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COVID-19

COVID-19: latest updates

The latest updates?on the COVID-19 pandemic from the European Medicines Agency (EMA)?are available below.

What's new

DATETOPICUPDATEMORE
INFORMATION
29/04/2021COVID-19 treatments: under evaluation
EMA's?CHMP started evaluating an application to extend the use of immunosuppressant Olumiant (baricitinib) for the treatment of COVID-19
EMA starts evaluating use of Olumiant in hospitalised COVID-19 patients requiring supplemental oxygen
28/04/2021COVID-19 vaccines: authorised
EMA updated the product information for Vaxzevria in all EU languages to include a new manufacturing site
Vaxzevria (previously COVID-19 Vaccine AstraZeneca)
26/04/2021COVID-19 vaccines: Article 5(3) reviewsEMA published the assessment report for the CHMP's analysis of benefits and risks of Vaxzevria in different age groups and at different infection rates?
26/04/2021Monitoring of COVID-19 medicinesEMA and ECDC launched an initiative to strengthen post-marketing monitoring of the safety, effectiveness and impact of COVID-19 vaccines in the EU?EMA and ECDC join forces for enhanced post-marketing monitoring of COVID-19 vaccines in Europe
26/04/2021COVID-19 vaccines: authorisedEMA published?a?direct healthcare professional communication (DHPC) on how to monitor and report any suspected adverse reactions with COVID-19 Vaccine JanssenCOVID-19 Vaccine Janssen
23/04/2021COVID-19 vaccines: Article 5(3) reviewsEMA’s CHMP provided further analysis of the benefits and risks of Vaxzevria in different age groups and at different infection rates, to help inform national decisions on the use of the vaccineAstraZeneca’s COVID-19 vaccine: benefits and risks in context
23/04/2021COVID-19 vaccines: authorisedEMA’s CHMP adopted recommendations to increase COVID-19 vaccine manufacturing capacity and supply in the EUIncrease in vaccine manufacturing capacity and supply for COVID-19 vaccines from BioNTech/Pfizer and Moderna
23/04/2021COVID-19 vaccines: authorised
EMA published a new safety update for COVID-19 Vaccine Janssen
COVID-19 Vaccine Janssen
21/04/2021COVID-19 vaccines: authorised
EMA published the updated product information for COVID-19 Vaccine Janssen, following endorsement of PRAC’s recommendations by CHMP
COVID-19 Vaccine Janssen
20/04/2021COVID-19 vaccines: authorised
EMA published the updated product information for Comirnaty in all EU languages
Comirnaty
20/04/2021COVID-19 vaccines: authorisedEMA’s safety committee (PRAC) concluded that unusual blood clots with low blood platelets should be listed as a very rare side effect with COVID-19 Vaccine JanssenCOVID-19 Vaccine Janssen: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets
16/04/2021COVID-19 vaccines: authorisedEMA updated the?product information?for Vaxzevria to include a new manufacturing siteVaxzevria (previously COVID-19 Vaccine AstraZeneca)
16/04/2021COVID-19 vaccines: authorised
EMA published new safety updates for Comirnaty, COVID-19 Vaccine Janssen and Vaxzevria
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15/04/2021COVID-19 vaccines: authorised
EMA updated the product information for Comirnaty and Vaxzevria
Comirnaty

Vaxzevria (previously COVID-19 Vaccine AstraZeneca)
15/04/2021COVID-19 treatments: Article 5(3) reviewsEMA's?CHMP?started an Article 5(3) review of the monoclonal antibody VIR-7831 to treat COVID-19, to support national authorities who may decide on the use of this medicine for COVID-19 prior to authorisationEMA starts review of VIR-7831 for treating patients with COVID-19
14/04/2021COVID-19 vaccines: Article 5(3) reviewsEMA's?CHMP?started an Article 5(3) review of?AstraZeneca’s COVID-19 vaccine,?Vaxzevria, to provide further context on the risk of very rare blood clots with low blood plateletsAstraZeneca’s COVID-19 vaccine: EMA to provide further context on risk of very rare blood clots with low blood platelets
14/04/2021COVID-19 vaccines: authorisedEMA’s safety committee (PRAC) is reviewing very rare cases of unusual blood clots with low platelets following the use of Janssen’s COVID-19 vaccine in the USACOVID-19 Vaccine Janssen: assessment of very rare cases of unusual blood clots with low platelets continues
13/04/2021COVID-19 vaccines: authorised
EMA published the assessment report for its review of reported cases of blood clots with AstraZeneca’s COVID-19 vaccine, Vaxzevria
Vaxzevria (previously COVID-19 Vaccine AstraZeneca)
13/04/2021COVID-19 vaccines: authorised
EMA updated the?direct healthcare professional communication (DHPC) on how to monitor and report any suspected adverse reactions with AstraZeneca’s COVID-19 vaccine, Vaxzevria
Vaxzevria (previously COVID-19 Vaccine AstraZeneca)
09/04/2021COVID-19 vaccines: authorisedEMA published the updated?product information?for AstraZeneca’s COVID-19 vaccine in all EU languages, following endorsement of PRAC’s recommendations by CHMP and the European Commission
08/04/2021COVID-19 vaccines: authorisedEMA published the updated product information for AstraZeneca’s COVID-19 vaccine following endorsement of the PRAC’s recommendation by CHMPVaxzevria (previously COVID-19 Vaccine AstraZeneca)
07/04/2021COVID-19 vaccines: authorisedEMA reminded healthcare professionals and people receiving AstraZeneca’s COVID-19 vaccine to remain aware of the possibility of very rare cases of blood clotsAstraZeneca’s COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets
31/03/2021COVID-19 vaccines: authorised
EMA’s PRAC is continuing its?review of?reported cases of blood clots with AstraZeneca’s COVID-19 vaccine; its?preliminary assessment report is available
AstraZeneca COVID-19 vaccine: review of very rare cases of unusual blood clots continues
30/03/2021COVID-19 vaccines: authorisedEMA published safety updates for Comirnaty, COVID-19 Vaccine Moderna and Vaxzevria?
29/03/2021COVID-19 guidance: research and developmentEMA has extended the availability of free scientific advice for potential COVID-19 treatments and vaccines to 15 September 2021?
29/03/2021Transparency: exceptional measures for COVID-19 medicinesEMA published the video recording and presentation slides from its public
meeting on COVID-19 vaccines on 26 March 2021
Public stakeholder meeting: approval, safety monitoring and impact of COVID-19 vaccines in the EU
26/03/2021COVID-19 vaccines: authorised
EMA updated the product information for AstraZeneca’s COVID-19 vaccine, to include the Halix manufacturing site and the new name of the product, Vaxzevria
Vaxzevria (previously COVID-19 Vaccine AstraZeneca)
26/03/2021COVID-19 vaccines: authorisedEMA’s CHMP adopted recommendations to increase COVID-19 vaccine manufacturing capacity and supply in the EUIncrease in vaccine manufacturing capacity and supply for COVID-19 vaccines from AstraZeneca, BioNTech/Pfizer and Moderna
26/03/2021COVID-19 treatments: Article 5(3) reviews
EMA concluded that regdanvimab can be used in COVID-19 patients not requiring oxygen and at high risk of progressing to severe disease
EMA issues advice on use of regdanvimab for treating COVID-19
26/03/2021Transparency: exceptional measures for COVID-19 medicines
EMA published an open letter in response to questions it had received about COVID-19 vaccines
25/03/2021COVID-19 vaccines: authorised
EMA’s safety committee (PRAC) is continuing its assessment of reported cases of blood clots with COVID-19 Vaccine AstraZeneca
COVID-19 Vaccine AstraZeneca – Update on ongoing evaluation of blood clot cases
24/03/2021COVID-19 treatments: Article 5(3) reviews
EMA published the assessment report for its review of the antibody combination bamlanivimab / etesevimab in COVID-19 patients
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24/03/2021COVID-19 vaccines: authorisedEMA published?a?direct healthcare professional communication (DHPC) on how to monitor and report any suspected adverse reactions with COVID-19 Vaccine AstraZenecaVaxzevria (previously COVID-19 Vaccine AstraZeneca)
23/03/2021COVID-19 vaccines: authorised
EMA published updated product information for COVID-19 Vaccine AstraZeneca in all EU languages, following its review of a signal of blood clots
Vaxzevria (previously COVID-19 Vaccine AstraZeneca)
22/03/2021Public-health advice during COVID-19 pandemicEMA concluded a review of the use of ivermectin for the prevention and the treatment of COVID-19EMA advises against use of ivermectin for the prevention or treatment of COVID-19 outside randomised clinical trials
22/03/2021Transparency: exceptional measures for COVID-19 medicines
EMA will hold a third public meeting on 26 March 2021 to provide an update on the assessment, approval and safety monitoring of COVID-19 vaccines
Public stakeholder meeting: approval, safety monitoring and impact of COVID-19 vaccines in the EU
19/03/2021COVID-19 vaccines: authorised
EMA's CHMP endorsed PRAC’s recommendations following review of a signal of blood clots and agreed to update?the product information of COVID-19 Vaccine AstraZeneca
Vaxzevria (previously COVID-19 Vaccine AstraZeneca)
18/03/2021COVID-19 vaccines: authorisedEMA published the?full assessment report and risk management plan?for COVID-19 Vaccine Janssen.COVID-19 Vaccine Janssen
18/03/2021COVID-19 vaccines: authorised
EMA’s safety committee (PRAC) concluded its preliminary review of a signal of blood clots in people vaccinated with COVID-19 Vaccine AstraZeneca.
COVID-19 Vaccine AstraZeneca: benefits still outweigh the risks despite possible link to rare blood clots with low blood platelets
16/03/2021COVID-19 vaccines: authorisedEMA published an update on its investigation of COVID-19 Vaccine AstraZeneca and thromboembolic events.Investigation of COVID-19 Vaccine AstraZeneca and thromboembolic events continues
16/03/2021COVID-19 vaccines: under evaluationEMA published?a?paediatric investigation plan?for the COVID-19 vaccine NVX-CoV2373, developed by?Novavax CZ AS.?
15/03/2021COVID-19 vaccines: authorisedEMA’s safety committee (PRAC) will meet on 18 March to further discuss the information gathered on COVID-19 Vaccine AstraZeneca and thromboembolic events.EMA’s safety committee continues investigation of COVID-19 Vaccine AstraZeneca and thromboembolic events – further update
15/03/2021COVID-19 guidance: evaluation and marketing authorisationEMA published guidance on flexibilities to help developers of COVID-19 treatments?with packaging and?labelling.?
11/03/2021COVID-19 vaccines: authorisedThe European Commission authorised the fourth COVID-19 vaccine in the EU,?COVID-19 Vaccine Janssen, following evaluation by EMA.?
11/03/2021COVID-19 vaccines: authorisedEMA published the clinical data supporting the authorisation of Comirnaty. Health Canada also published these data at the same time.Clinical data?(login required)
11/03/2021COVID-19 vaccines: authorisedEMA confirmed that COVID-19 Vaccine AstraZeneca’s can continue to be administered while investigations are ongoing.COVID-19 Vaccine AstraZeneca: PRAC investigating cases of thromboembolic events - vaccine’s benefits currently still outweigh risks - Update
11/03/2021COVID-19 treatments: Article 5(3) reviewsEMA published the assessment report of its review of the REGN-COV2 antibody combination (casirivimab / imdevimab) in COVID-19 patients.?
11/03/2021COVID-19 vaccines: under evaluationEMA's?CHMP?issued a positive opinion for a?conditional marketing authorisation?for the COVID-19 vaccine developed by Janssen-Cilag International N.V.EMA recommends COVID-19 Vaccine Janssen for authorisation in the EU
11/03/2021COVID-19 treatments: under evaluationEMA's?CHMP?has started a rolling review of two?monoclonal antibodies from?Eli Lilly for the treatment of?COVID-19.EMA starts rolling review of Eli Lilly antibodies bamlanivimab and etesevimab for COVID-19
10/03/2021COVID-19 treatments: authorisedEMA is reviewing a batch of COVID-19 Vaccine AstraZeneca that has been suspended in some EU countries.COVID-19 Vaccine AstraZeneca: PRAC preliminary view suggests no specific issue with batch used in Austria
10/03/2021Public-health advice during COVID-19 pandemicThe info-card for healthcare professionals on how to report suspected side effects with medicines is now available in all EU languages.?
05/03/2021COVID-19 treatments: Article 5(3) reviewsEMA concluded that bamlanivimab and etesevimab can be used together in COVID-19 patients not requiring oxygen and at high risk of progressing to severe disease.EMA issues advice on use of antibody combination (bamlanivimab / etesevimab)
04/03/2021COVID-19 vaccines: authorisedEMA published safety updates for Comirnaty and COVID-19 Vaccine Moderna.?
04/03/2021COVID-19 vaccines: under evaluationEMA’s?CHMP?has started the rolling review of the COVID-19 vaccine Sputnik V (Gam-COVID-Vac), developed by Russia’s Gamaleya National Centre of Epidemiology and Microbiology.EMA starts rolling review of the Sputnik V COVID-19 vaccine
02/03/2021COVID-19 vaccines: under evaluationEMA’s CHMP will hold an extraordinary meeting on 11 March to consider COVID-19 Vaccine Janssen. The aim of the meeting is to conclude the evaluation, if possible.Extraordinary meeting of the Committee for Medicinal Products for Human Use (CHMP): 11 March 2021
02/03/2021COVID-19 treatments: Article 5(3) reviewsEMA's?CHMP?started an Article 5(3) review of the monoclonal antibody regdanvimab to treat COVID-19, to support national authorities who may decide on the use of this medicine for COVID-19 prior to authorisation.EMA review of regdanvimab for COVID-19 to support national decisions on early use
02/03/2021COVID-19 vaccines: authorised
EMA and?Health Canada published the full clinical data supporting their authorisations of COVID-19 Vaccine Moderna.
EMA and Health Canada publish clinical data used to support their authorisations of the Moderna COVID-19 vaccine
26/02/2021COVID-19 treatments: Article 5(3) reviewsEMA concluded that casirivimab / imdevimab can be used in COVID-19 patients not requiring oxygen and at high risk of progressing to severe disease.EMA issues advice on use of REGN-COV2 antibody combination (casirivimab / imdevimab)
25/02/2021Treatments and vaccines for COVID-19EMA published guidance for developers planning to adapt COVID-19 vaccines to address SARS-CoV-2 variants.Adapting COVID-19 vaccines to SARS-CoV-2 variants: guidance for vaccine manufacturers
25/02/2021International Coalition of Medicines Regulatory Authorities (ICMRA)
At their workshop on 10 February 2021,?ICMRA members discussed surveillance activities and data requirements for updating available vaccines against new virus strains. A report is available.
International cooperation to align approaches for regulation of COVID-19 vaccines and medicines
25/02/2021International Coalition of Medicines Regulatory Authorities (ICMRA)
At their workshop on 9 February 2021,?ICMRA members discussed issues around COVID-19 medicines in pregnant and breastfeeding women, including knowledge gaps and how to overcome them. A report is available.
International cooperation to align approaches for regulation of COVID-19 vaccines and medicines
24/02/2021Treatments and vaccines for COVID-19EMA’s?CHMP?has started the rolling review of a monoclonal antibody for the treatment of COVID-19 from Celltrion.EMA starts rolling review of Celltrion antibody regdanvimab for COVID-19
18/02/2021Treatments and vaccines for COVID-19EMA published the?European public assessment report?for COVID-19 Vaccine?AstraZeneca.?
16/02/2021Treatments and vaccines for COVID-19EMA’s?CHMP?began evaluating an application for?conditional marketing authorisation?for COVID-19 Vaccine Janssen, developed by Janssen-Cilag International N.V.EMA receives application for conditional marketing authorisation of COVID-19 Vaccine Janssen
16/02/2021Treatments and vaccines for COVID-19EMA published?a?paediatric investigation plan?for COVID-19 Vaccine Janssen, developed by Janssen-Cilag International N.V.?
12/02/2021Treatments and vaccines for COVID-19EMA’s?CHMP?has started the rolling review of the COVID-19 vaccine CVnCoV. The vaccine is being developed by CureVac AG.EMA starts rolling review of CureVac’s COVID-19 vaccine (CVnCoV)
10/02/2021COVID-19 vaccines: key factsEMA has requested all COVID-19 vaccine developers to investigate if their vaccine can offer protection against any new virus variants, and to submit relevant data.EMA preparing guidance to tackle COVID-19 variants
10/02/2021Treatments and vaccines for COVID-19EMA clarified that it has not received an application for a rolling review or a marketing authorisation for the Sputnik V vaccine (Gam-COVID-Vac) developed by the Gamaleya National Centre of Epidemiology and Microbiology in Russia, despite reports stating the opposite.Clarification on Sputnik V vaccine in the EU approval process
08/02/2021International Coalition of Medicines Regulatory Authorities (ICMRA)At their workshop on 25 January 2021, ICMRA members shared information on COVID-19 observational studies and discussed progress with international cohort building, pregnancy studies, vaccines surveillance and pharmacovigilance.International regulators working together to enhance collaboration on COVID-19 observational research
05/02/2021Treatments and vaccines for COVID-19EMA published the first safety update for COVID-19 Vaccine Moderna.?
04/02/2021Treatments and vaccines for COVID-19EMA's?CHMP?started reviewing data on the use of combinations of monoclonal antibodies to treat COVID-19.EMA reviewing data on monoclonal antibody use for COVID-19
04/02/2021EMA’s governance during COVID-19 pandemicEMA is running a pilot of non-EU regulators and WHO?taking part in its scientific evaluations.
03/02/2021Treatments and vaccines for COVID-19EMA’s?CHMP?has started the rolling review of the COVID-19 vaccine NVX-CoV2373. The vaccine is being developed by Novavax CZ AS.
01/02/2021Treatments and vaccines for COVID-19EMA’s CHMP has started the rolling review of a medicine to treat and prevent COVID-19. It is being developed by Regeneron Pharmaceuticals, Inc. and F. Hoffman-La Roche, Ltd (Roche).EMA starts rolling review of REGN-COV2 antibody combination (casirivimab / imdevimab)
29/01/2021Treatments and vaccines for COVID-19The European Commission authorised the third COVID-19 vaccine in the EU,?COVID-19 Vaccine AstraZeneca, following evaluation by EMA.?
29/01/2021Treatments and vaccines for COVID-19EMA's?CHMP?issued a positive opinion for a?conditional marketing authorisation?for the COVID-19 vaccine developed by AstraZeneca and University of Oxford.EMA recommends COVID-19 Vaccine AstraZeneca for authorisation in the EU
29/01/2021Treatments and vaccines for COVID-19EMA published its first COVID-19 vaccine safety update, beginning with an update on the safety of Comirnaty.First COVID-19 vaccine safety update published
28/01/2021Treatments and vaccines for COVID-19EMA's?CHMP?updated?the?product information?for Comirnaty?to clarify its position on the interval between the first and second doses.Clarification of Comirnaty dosage interval
22/01/2021EMA’s governance during COVID-19 pandemicEMA is holding meetings for its scientific committees, working parties and stakeholders virtually until further notice.?
20/01/2021Public-health advice during COVID-19 pandemicThe info-card for patients on how to report suspected side effects with medicines is now available in all EU languages.?
20/01/2021Treatments and vaccines for COVID-19EMA published the?European public assessment report?for COVID-19 Vaccine Moderna.COVID-19 Vaccine Moderna:?European public assessment report
19/01/2021International Coalition of Medicines Regulatory Authorities (ICMRA)ICMRA has developed a statement to inform and help healthcare professionals answer questions about COVID-19 vaccines.Global regulators highlight key role of healthcare professionals in fostering confidence in COVID-19 vaccines
15/01/2021Transparency: exceptional measures for COVID-19 medicinesEMA extended its target timeframe for publishing European public assessment reports for COVID-19 medicines.??
14/01/2021Coronavirus disease (COVID-19)
Information on COVID-19 from EU / EEA?Member States is available in national languages.
Heads of Medicines Agencies (HMA): information on COVID-19
12/01/2021Treatments and vaccines for COVID-19
EMA’s CHMP began evaluating an application for conditional marketing authorisation for the COVID-19 vaccine ChAdOx1-SARS-CoV-2 developed by AstraZeneca and?University of Oxford.
EMA receives application for conditional marketing authorisation of COVID-19 Vaccine AstraZeneca
08/01/2021Treatments and vaccines for COVID-19EMA's CHMP?recommended?updating the product information for Comirnaty:?each vial contains 6 doses.
06/01/2021Treatments and vaccines for COVID-19
The European Commission authorised the second vaccine to prevent COVID-19 in the EU, COVID-19 Vaccine Moderna, following evaluation by EMA.?
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06/01/2021Treatments and vaccines for COVID-19
EMA's?CHMP?issued a positive opinion for a conditional marketing authorisation for the COVID-19 vaccine developed by Moderna Biotech Spain, S.L.
EMA recommends COVID-19 Vaccine Moderna for authorisation in the EU
05/01/2021Treatments and vaccines for COVID-19EMA published?a paediatric investigation plan?for the COVID-19 vaccine ChAdOx1-SARS-CoV-2 developed by AstraZeneca,?in collaboration with the University of Oxford.?
30/12/2020Treatments and vaccines for COVID-19EMA provided an update on the rolling review for the COVID-19 vaccine ChAdOx1-SARS-COV-2 developed by AstraZeneca and Oxford University.Update on rolling review of AstraZeneca’s COVID-19 vaccine
23/12/2020Treatments and vaccines for COVID-19EMA published the European public assessment report for Comirnaty,?the first COVID-19 vaccine to be authorised in the EU.?Comirnaty:?European public assessment report
22/12/2020Transparency: exceptional measures for COVID-19 medicinesEMA is holding a second public meeting on 8 January 2021 to inform European citizens about the assessment, approval and roll-out of new COVID-19 vaccines.EMA organises a second public meeting about the new COVID-19 vaccines
21/12/2020Treatments and vaccines for COVID-19The European Commission authorised the first vaccine to prevent COVID-19 in the EU, following evaluation by EMA.?European Commission: Union Register of medicinal products for human use
21/12/2020Treatments and vaccines for COVID-19EMA's CHMP issued its first positive opinion on a vaccine to prevent COVID-19 in the EU.?EMA recommends first COVID-19 vaccine for authorisation in the EU
18/12/2020Treatments and vaccines for COVID-19EMA published paediatric investigation plans for the COVID-19 vaccines BNT162b2?developed by BioNTech and Pfizer and mRNA-1273 developed by Moderna.??
17/12/2020Treatments and vaccines for COVID-19EMA provided an update on the evaluation timeline for the COVID-19 vaccine mRNA-1273 developed by Moderna.Update on assessment of marketing authorisation application for Moderna’s mRNA-1273 COVID-19 vaccine
15/12/2020Treatments and vaccines for COVID-19EMA provided an update on the evaluation timeline for the COVID-19 vaccine BNT162b2 developed by BioNTech and Pfizer.?Update on assessment of the BioNTech and Pfizer BNT162b2 vaccine marketing authorisation application
11/12/2020Treatments and vaccines for COVID-19EMA held a virtual meeting to explain the processes for the?development, evaluation, approval and safety monitoring of COVID-19 vaccines?in the EU.Public stakeholder meeting: development and authorisation of safe and effective COVID-19 vaccines in the EU
14/12/2020Treatments and vaccines for COVID-19EMA signed a contract with Utrecht University to study the safety of COVID-19 vaccines in EU Member States.?
11/12/2020Treatments and vaccines for COVID-19EMA published information on the studies for the approval of COVID-19 vaccines.?
10/12/2020Transparency: exceptional measures for COVID-19 medicinesEMA updated information on its exceptional transparency measures to cover post-authorisation procedures?
01/12/2020Treatments and vaccines for COVID-19EMA’s?CHMP?has started the rolling review of the COVID-19 vaccine Ad26.COV2.S. The vaccine is being developed by Janssen-Cilag International N.V.EMA starts rolling review of Janssen’s COVID-19 vaccine Ad26.COV2.S
01/12/2020Treatments and vaccines for COVID-19EMA’s?CHMP?began evaluating an application for conditional marketing authorisation for the COVID-19 vaccine mRNA-1273 by Moderna Biotech Spain, S.L.EMA receives application for conditional marketing authorisation of Moderna COVID-19 vaccine
01/12/2020Treatments and vaccines for COVID-19EMA’s?CHMP?began evaluating an application for conditional marketing authorisation for the COVID-19 vaccine BNT162b2 developed by BioNTech and Pfizer.EMA receives application for conditional marketing authorisation of COVID-19 mRNA vaccine BNT162b2
27/11/2020Guidance for medicine developers and other stakeholders on COVID-19EMA published guidance on flexibilities to help developers of COVID-19 vaccines prepare and roll out packaging and?labelling?for their vaccines quickly.?
27/11/2020International Coalition of Medicines Regulatory Authorities (ICMRA)ICMRA members encouraged?stakeholders responsible for clinical trials of COVID-19 vaccines to continue running these trials for as long as is feasible.Global regulators urge continuation of COVID-19 vaccine trials for longer-term safety and efficacy follow-up
27/11/2020International Coalition of Medicines Regulatory Authorities (ICMRA)ICMRA members expressed their?support for regulatory reliance.?
27/11/2020Guidance for medicine developers and other stakeholders on COVID-19EMA published guidance for developers of COVID-19 vaccines and treatments on where to find the standards and requirements related to pharmaceutical quality that are applicable in the EU.?
20/11/2020Treatments and vaccines for COVID-19EMA provided an update on Veklury (remdesivir), after the World Health Organization (WHO) had issued conditional recommendations against its use in hospitalised patients with COVID-19.Update on remdesivir - EMA will evaluate new data from Solidarity trial
20/11/2020Guidance for medicine developers and other stakeholders on COVID-19EMA and the Heads of Medicines Agencies (HMA) encouraged developers of COVID-19 vaccines to use the?centralised procedure?for their EU marketing authorisation applications.HMA/EMA statement on approval of vaccines?
19/11/2020Treatments and vaccines for COVID-19EMA is holding a virtual public meeting on Friday 11 December to explain the regulatory processes for COVID-19 vaccines and to listen to European citizens’ needs, expectations and concerns.EMA organises public meeting on COVID-19 vaccines
19/11/2020Treatments and vaccines for COVID-19EMA published guidance for developers of potential COVID-19 vaccines on the?clinical evidence?to include in their?marketing authorisation application.EMA considerations on COVID-19 vaccine approval
16/11/2020Treatments and vaccines for COVID-19EMA’s?CHMP has started the rolling review of a?third?COVID-19 vaccine. The vaccine is being developed by Moderna?Biotech Spain, S.L.EMA starts rolling review of mRNA COVID-19 vaccine by Moderna Biotech Spain, S.L.
13/11/2020COVID-19 vaccines: development, evaluation, approval and monitoringEMA and the national competent authorities have prepared a safety monitoring plan for COVID-19 vaccines. Guidance is also available on preparing risk management plans for COVID-19 vaccines.?EMA publishes safety monitoring plan and guidance on risk management planning for COVID-19 vaccines
06/11/2020International Coalition of Medicines Regulatory Authorities (ICMRA)ICMRA and?the World Health Organization have committed to work together to enable the earliest possible patient access to safe and effective medicines against COVID-19 worldwide.International regulators and WHO join forces to address COVID-19 challenges
30/10/2020Transparency: exceptional measures for COVID-19 medicinesEMA’s Executive Director sent an open letter?to members of the European Parliament, in response to their enquiry on transparency related to the evaluation of COVID-19 vaccines.Reply to open letter concerning the transparency and evaluation of vaccines for COVID-19
30/10/2020Treatments and vaccines for COVID-19EMA has published a list of COVID-19? treatments and vaccines that have received scientific advice or informal guidance from EMA’s pandemic Task Force.Extra transparency measures for COVID-19 vaccines and therapeutics
30/10/2020Treatments and vaccines for COVID-19EMA has published the clinical data supporting the initial authorisation of Veklury (remdesivir).Extra transparency measures for COVID-19 vaccines and therapeutics
23/10/2020International Coalition of Medicines Regulatory Authorities (ICMRA)At their workshop on 13 October, ICMRA members discussed their experiences supporting and assessing real-world evidence to facilitate regulatory decision-making on COVID-19 treatments and vaccines.Strengthening global collaboration on COVID-19 real-world evidence and observational studies
06/10/2020Treatments and vaccines for COVID-19EMA’s?CHMP has started the rolling review of a second COVID-19 vaccine. The vaccine is being developed by BioNTech in collaboration with Pfizer.EMA starts second rolling review of a COVID-19 vaccine
05/10/2020EMA’s governance during COVID-19 pandemicEMA’s Executive Director sent an open letter to the European Ombudsman, in response to her enquiry on the transparency and independence of EMA’s activities in supporting the development and evaluation of COVID-19 medicines.EU regulators fully uphold transparency and independence standards for COVID-19 treatments and vaccines
01/10/2020Treatments and vaccines for COVID-19EMA’s CHMP has started the first rolling review of a COVID-19 vaccine. It is being developed by the company AstraZeneca in collaboration with Oxford University.EMA starts first rolling review of a COVID-19 vaccine in the EU
01/10/2020COVID-19 vaccines: key factsEMA has published information on the development and evaluation of safe and effective vaccines for COVID-19.??
29/09/2020Treatments and vaccines for COVID-19EMA?had finalised?30?scientific advice?procedures?for potential medicines to treat COVID-19, with a further 21?ongoing. It had also been in contact with the developers of?163?potential COVID-19 treatments and?39?potential COVID-19 vaccines.?
18/09/2020Treatments and vaccines for COVID-19EMA has endorsed the use of dexamethasone for the treatment of hospitalised adults and adolescents patients with COVID-19 who are receiving respiratory support.EMA endorses use of dexamethasone in COVID-19 patients on oxygen or mechanical ventilation
18/09/2020EMA’s governance during COVID-19 pandemicEMA, the European Commission and the Heads of Medicines Agencies (HMA) updated the European medicines regulatory network's business continuity plan to cover pharmacovigilance and inspection procedures.?
02/09/2020Treatments and vaccines for COVID-19EMA?had finalised 17?scientific advice?procedures?for potential medicines to treat COVID-19, with a further 22?ongoing. It had also been in contact with the developers of?158?potential COVID-19 treatments and?38 potential COVID-19 vaccines.?
02/09/2020Treatments and vaccines for COVID-19EMA’s?CHMP?began evaluating Dexamethasone Taw for a?marketing authorisation?for the?treatment of hospitalised adult patients?with COVID-19.EMA receives application for marketing authorisation of Dexamethasone Taw for COVID-19
20/08/2020EMA’s governance during COVID-19 pandemicEMA decided to continue holding its committee and working-party meetings and its stakeholder events virtually until the end of 2020.?
31/07/2020Treatments and vaccines for COVID-19EMA?had finalised 17 scientific advice?procedures?for potential medicines to treat COVID-19, with a further 15 ongoing. It had also been in contact with the developers of?154 potential COVID-19 treatments and?38 potential COVID-19 vaccines.?
31/07/2020International Coalition of Medicines Regulatory Authorities (ICMRA)Progress is being made on developing a pharmacovigilance network for vaccines, carrying out research in pregnant women and the establishment of international patient cohorts.Global regulatory workshop on COVID-19 real-world evidence and observational studies?
31/07/2020International Coalition of Medicines Regulatory Authorities (ICMRA)Regulatory authorities are receiving numerous proposals for phase 3 clinical trials from developers of COVID-19 treatments. Regulators have agreed on acceptable clinical-trial endpoints to facilitate rapid and consistent clinical trials for COVID-19 treatments.Global regulatory workshop on COVID-19 therapeutics #2: agreement on acceptable endpoints for clinical trials
24/07/2020Treatments and vaccines for COVID-19EMA's CHMP started a review under Article 5(3) of Regulation 726/2004 of the results of a study using dexamethasone in hospitalised patients with COVID-19. CHMP will provide an opinion on the results of the study and on the potential use of dexamethasone to treat adults with COVID-19.EMA starts review of dexamethasone for treating adults with COVID-19 requiring respiratory support
21/07/2020Treatments and vaccines for COVID-19EMA?is applying exceptional transparency measures for treatments and vaccines against?COVID-19 that are approved or are under evaluation, to address the high interest in information on?COVID-19 medicines and to support global research.?
21/07/2020Treatments and vaccines for COVID-19EMA signed a contract with Utrecht University to study the impact of COVID-19 infection and medicines in pregnancy. This project completes EMA's infrastructure to support the real-world monitoring of COVID-19 treatments and vaccines.COVID-19: EMA sets up infrastructure for real-world monitoring of treatments and vaccines
16/07/2020Treatments and vaccines for COVID-19EMA had finalised 9 scientific advice procedures for potential medicines to treat COVID-19, with a further 13 ongoing. It had also been in contact with the developers of 148 potential COVID-19 treatments and 36 potential COVID-19 vaccines.?
14/07/2020Guidance for medicine developers and other stakeholders on COVID-19EMA urged?researchers to adhere to the latest revision of the ENCePP Guide on methodological standards in pharmacoepidemiology.?The?foreword highlights?chapters relevant to COVID-19 and examples of good practice.European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP)
09/07/2020International Coalition of Medicines Regulatory Authorities (ICMRA)ICMRA published a report summarising its second workshop on the development of COVID-19 vaccines. The report highlights key considerations and data requirements for the design and conduct of phase 3 clinical trials.International regulators align positions on phase 3 COVID-19 vaccine trials
06/07/2020Treatments and vaccines for COVID-19The European Public Assessment Report (EPAR) for Veklury (remdesivir), including CHMP's assessment report, is available.Veklury
06/07/2020Guidance for medicine developers and other stakeholders on COVID-19EMA?provided a template and dedicated email address for notifications of exceptional change management process (ECMP), as foreseen in the questions and answers on regulatory expectations for medicinal products for human use during the COVID-19 pandemic.?
03/07/2020Treatments and vaccines for COVID-19The European Commission granted a conditional marketing authorisation for Veklury (remdesivir), for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen. Veklury is the first treatment against COVID-19 in the EU.

European Commission authorises first treatment against COVID-19??

03/07/2020Treatments and vaccines for COVID-19EMA?has been in contact with the developers of:
  • 144 potential COVID-19 treatments;
  • 35?potential COVID-19 vaccines.
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01/07/2020International Coalition of Medicines Regulatory Authorities (ICMRA)EMA endorsed a joint statement on clinical trials?from the International Coalition of Medicines Regulatory Authorities (ICMRA), which outlines the characteristics of COVID-19 trials most likely to generate conclusive evidence, and encourages adequate patient enrolment and public reporting of results.International regulators provide guiding principles for COVID-19 clinical trials
01/07/2020Guidance for medicine developers and other stakeholders on COVID-19EMA, the European Commission and the Heads of Medicine Agencies updated their?questions and answers on regulatory expectations for medicinal products for ?human use during the COVID-19 pandemic?to cover pharmacovigilance inspections, system audits and the management of corrective and preventive actions (CAPAs).?
01/07/2020Guidance for medicine developers and other stakeholders on COVID-19EMA, the European Commission and the Heads of Medicine Agencies updated their?questions and answers on regulatory expectations for medicinal products for veterinary use during the COVID-19 pandemic?to cover pharmacovigilance inspections.?
30/06/2020EMA’s governance during COVID-19 pandemicEMA and the Ministry of Food and Drug Safety of the Republic of Korea (MFDS) signed an ad hoc confidentiality agreement to share confidential information and documents on COVID-19 and medicines intended for its diagnosis, prevention or treatment.EMA and Korean Ministry of Food and Drug Safety to share confidential COVID-19 information
29/06/2020EMA’s governance during COVID-19 pandemicEMA decided to continue holding its committee and working-party meetings virtually until the end of September 2020. Stakeholder events planned until the end of September will either be postponed or held virtually.?
29/06/2020Guidance for medicine developers and other stakeholders on COVID-19EMA revised its guidance on? PDF icon Implications of COVID-19?on methodological aspects of ongoing clinical trials following a four-week public consultation.?
25/06/2020Treatments and vaccines for COVID-19EMA's CHMP recommended for approval the first treatment against COVID-19 in the EU. CHMP gave a positive opinion for a conditional marketing authorisation for Veklury (remdesivir), for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen.First COVID-19 treatment recommended for EU authorisation
24/06/2020International Coalition of Medicines Regulatory Authorities (ICMRA)EMA and the United States Food and Drug Administration?(FDA) jointly chaired the second regulatory workshop on the development of COVID-19 vaccines on Monday 22 June, under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). Participants discussed certain methodological aspects and data requirements for the design and conduct of phase 3 clinical trials.Global regulators discuss data requirements for phase 3 trials of COVID-19 vaccines
24/06/2020Treatments and vaccines for COVID-19EMA contracted IQVIA Ltd. on 8 June 2020 to carry out a project to build a framework for the conduct of multicentre cohort studies on the use of medicines in COVID-19 patients.?
22/06/2020Treatments and vaccines for COVID-19EMA and the United States Food and Drug Administration (FDA) shared their experiences and challenges in facilitating the development, review and availability of COVID-19 vaccines at their 2020 bilateral meeting, among other topics. They also?discussed the use of real world evidence to support regulatory decisions.European Commission, EMA and FDA agree new priorities to strengthen their collaboration on medicines
16/06/2020Treatments and vaccines for COVID-19EMA?has been in contact with the developers of:
  • 132?potential COVID-19 treatments;
  • 34?potential COVID-19 vaccines.
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15/06/2020International Coalition of Medicines Regulatory Authorities (ICMRA)EMA participated in the fifth bi-weekly global regulators’ meeting on COVID-19-related policy approaches and regulatory flexibility on Friday, 12 June, under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). Participants focused on the planning, progress and prioritisation of COVID-19 clinical?trials.Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #4
15/06/2020Fees payable to the European Medicines AgencyEMA introduced a fee for its rolling review procedure. This fee is deductible from the fee EMA would charge for the marketing authorisation application once the company submits the full dossier following the rolling review. Micro, small and medium-sized enterprises (SMEs) are eligible for a 90% fee reduction?for the rolling review. PDF icon Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures - Revised implementing rules to the Fee Regulation as of 12 June 2020
10/06/2020Good clinical practice (GCP) inspection proceduresEMA published PDF icon guidance on remote good-clinical-practice (GCP) inspections during the pandemic. This is the first in a series of guidance documents on remote inspections for the verification of compliance with EU and international standards during the pandemic.?
10/06/2020Treatments and vaccines for COVID-19EMA extended its medical literature monitoring service to cover authorised active substances that could help treat COVID-19. EMA’s service aims to reduce duplication of effort and multiple reporting of suspected adverse events for active substances that have many marketing authorisation holders.Medical literature monitoring
10/06/2020Public-health advice during COVID-19 pandemicEMA reiterated its advice to patients and healthcare professionals that angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs, or sartan medicines) can continue to be used during the pandemic. This follows a review of recently published studies that showed no link between the use of these medicines and a higher risk of infection or worsening of COVID-19.Latest data support continued use of ACE inhibitors and ARB medicines during COVID-19 pandemic
08/06/2020Availability of medicines during COVID-19 pandemicEMA provided an update on the measures EU authorities are putting in place to support the continued availability of medicines during the pandemic, following a meeting of the EU Executive Steering Group on Shortages of Medicines Caused by Major Events. The steering group agreed that EMA would set up an ad hoc working group to improve the forecasting of future medicines demand in the EU, in preparation for a potential second wave of infections.EU actions to support availability of medicines during COVID-19 pandemic – update #7
08/06/2020Treatments and vaccines for COVID-19EMA’s CHMP formally began evaluating remdesivir for a conditional marketing authorisation. The CHMP will assess this application under the minimum timeframe necessary to allow for a thorough evaluation of the medicine’s benefits and risks. EMA also published its decision on the paediatric investigation plan (PIP) for remdesivir.EMA receives application for conditional authorisation of first COVID-19 treatment in the EU
08/06/2020Guidance for medicine developers and other stakeholders on COVID-19EMA published a visual guide on its fast-track procedures for COVID-19 treatments and vaccines.?
04/06/2020European Medicines Agency (EMA) Patients' and Consumers' (PCWP) and Healthcare Professionals' (HCPWP) Working Parties Joint - Virtual meetingEMA updated patients’ and healthcare professionals’ organisations about its COVID-19-related activities at a virtual meeting with the Patients’ and Consumers’ Working Party and the Healthcare Professionals’ Working Party on Tuesday, 2 June 2020. A recording of the meeting is available.Patients’ and healthcare professionals’ organisations updated on EMA’s response to COVID-19
29/05/2020Guidance for medicine developers and other stakeholders on COVID-19EMA and the United States Food and Drug Administration published PDF icon joint procedural assistance for medicine developers planning to submit a paediatric investigation plan (PIP) to EMA and an initial pediatric study plan (iPSP) to the FDA for a COVID-19 vaccine or treatment. The aim of the joint document is to make it easier for developers to submit paediatric development plans simultaneously to the regulators.?
29/05/2020International Coalition of Medicines Regulatory Authorities (ICMRA)The International Coalition of Medicines Regulatory Authorities (ICMRA) published a report summarising its global regulatory workshop on COVID-19 observational studies and the use of real-world data. The report provides an overview of global regulators’ priority areas for cooperation in the areas of pregnancy research, building international clinical cohorts, and preparing for vaccine safety and effectiveness monitoring.?
29/05/2020Public-health advice during COVID-19 pandemicEMA reminded healthcare professionals to closely monitor patients with COVID-19 who are receiving chloroquine or hydroxychloroquine. Several observational studies in COVID-19 have reported that chloroquine and hydroxychloroquine are associated with an increased risk of heart problems, a well-known side effect of such treatments, including cardiac arrhythmias and cardiac arrest.COVID-19: reminder of the risks of chloroquine and hydroxychloroquine
29/05/2020Treatments and vaccines for COVID-19EMA’s Executive Director sent an PDF icon open letter to researchers from the Institute for Quality and Efficiency in Health Care (IQWiG) and the Cochrane Collaboration, in response to their call for EMA to make the clinical data submitted as part of COVID-19-related evaluation procedures publicly available rapidly.?
29/05/2020Treatments and vaccines for COVID-19The rolling review of data on remdesivir concluded on 15 May 2020. The next step is for the company to submit an application for a conditional marketing authorisation, together with the additional data requested by EMA’s CHMP. The CHMP will assess this application under the minimum timeframe necessary to allow for a thorough evaluation of the medicine’s benefits and risks.?Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 May 2020
28/05/2020International Coalition of Medicines Regulatory Authorities (ICMRA)EMA chaired the fourth bi-weekly strategic meeting on COVID-19-related policy approaches and regulatory flexibility on Wednesday 27 May, under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). Participants discussed regulatory aspects of COVID-19 medicine development, pragmatic approaches to address challenges posed by the pandemic, and the mandate of the newly established ICMRA COVID-19 Working Group.Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #3
28/05/2020Guidance for medicine developers and other stakeholders on COVID-19EMA, the European Commission and the Heads of Medicine Agencies updated their guidance for pharmaceutical companies on adaptations to the regulatory framework to clarify the exceptional change-management process in place to reduce the risk of shortages or disruption of supply of crucial medicines for COVID-19. The update also introduces further temporary flexibility on good-manufacturing- and good-distribution-practice inspections and new guidance on inspections of plasma collection centres.?
28/05/2020EMA’s governance during COVID-19 pandemicEMA announced that essential work to combat the COVID-19 pandemic would continue during the Agency’s closure on 1 June.Essential work to combat the COVID-19 pandemic to continue during EMA's closure on 1 June 2020
28/05/2020EMA’s governance during COVID-19 pandemicEMA, together with the European Commission and the Heads of Medicines Agencies (HMA), published their PDF icon business continuity plan . This sets out principles to ensure that the European medicines regulatory network can continue to operate its core regulatory activities during the COVID-19 pandemic. It covers procedures related to medicines for COVID-19, as well as core procedures for other human and veterinary medicines.European medicines regulatory network fully mobilised in fight against COVID-19
27/05/2020Treatments and vaccines for COVID-19EMA gave an update stating that it had been in contact with the developers of around:
  • 125 potential COVID-19 treatments;
  • 33 potential COVID-19 vaccines.
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27/05/2020Treatments and vaccines for COVID-19EMA signed a contract with Utrecht University to conduct research into data sources and methods that can be used to monitor the safety, effectiveness and coverage of COVID-19 vaccines in clinical practice once they are authorised in the EU. Under the ACCESS (vACcine Covid-19 monitoring readinESS) project, researchers will identify a Europe-wide network of data sources and possible adverse events requiring extra consideration.EMA commissions independent research to prepare for real-world monitoring of COVID-19 vaccines
26/05/2020Guidance for medicine developers and other stakeholders on COVID-19EMA encouraged collaboration between EU researchers on high-quality, multi-centre observational studies of COVID-19 treatments and vaccines. A new COVID-19 response group, set up by the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), is in place to facilitate this collaboration. Recommendations on conducting high-quality observational research during the pandemic are also available in a recently published article by EMA staff and EU researchers.EMA calls for high-quality observational research in context of COVID-19
20/05/2020International Coalition of Medicines Regulatory Authorities (ICMRA)EMA and Health Canada jointly chaired the fourth global regulatory workshop on Tuesday 19 May, under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). The participants identified priority areas for cooperation on observational research during COVID-19: pregnancy research, medicines used in clinical practice, and monitoring vaccine safety and effectiveness.Global regulators commit to cooperate on observational research in the context of COVID-19
19/05/2020EMA’s governance during COVID-19 pandemicEMA decided to continue holding its committee and working-party meetings virtually until the end of August 2020. Stakeholder events planned until the end of August will either be postponed or held virtually.?
19/05/2020EMA’s governance during COVID-19 pandemicEMA announced that essential work to combat the COVID-19 pandemic would continue during the Agency’s closure from 21 to 22 May.Essential work to combat the COVID-19 pandemic to continue during EMA's closure on 1 June 2020
18/05/2020EMA’s governance during COVID-19 pandemicEMA’s Executive Director, Guido Rasi, attended the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) on Monday, 18 May, to respond to questions on EMA’s response to COVID-19. This followed his statement to the committee on Tuesday, 12 May. A recording of the session is available on the European Parliament’s website.?
18/05/2020International Coalition of Medicines Regulatory Authorities (ICMRA)
EMA participated in the third bi-weekly global regulators’ meeting on COVID-19-related policy approaches and regulatory flexibility on Thursday 14 May, under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). Participants discussed COVID-19 clinical-trial management, focusing in particular on the use of master protocols to help generate the robust evidence needed for regulatory decisions, and measures for mitigating medicine-supply issues.??
Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #2
15/05/2020Availability of medicines during COVID-19 pandemicEMA provided an update on the measures EU authorities are putting in place to support the continued availability of medicines during the pandemic, following a meeting of the EU Executive Steering Group on Shortages of Medicines Caused by Major Events.EU actions to support availability of medicines during COVID-19 pandemic – update #6
15/05/2020Guidance for medicine developers and other stakeholders on COVID-19Members of EMA staff and its scientific committees published an article setting out concrete actions that stakeholders involved in COVID-19 clinical trials should take in order to generate the conclusive evidence needed to enable rapid development and approval of potential treatments and vaccines against COVID-19. The article is available via open access on the website of Clinical Pharmacology & Therapeutics.International coordination needed to encourage conduct of large, decision-relevant COVID-19 clinical trials
14/05/2020Treatments and vaccines for COVID-19EMA held a virtual press briefing explaining its efforts to expedite the development and approval of COVID-19 treatments and vaccines, its role in ensuring the continued availability of crucial medicines in the EU during the pandemic, and its publication of reliable information for patients and healthcare professionals. The press briefing featured No?l Wathion, EMA’s Deputy Executive Director, and Marco Cavaleri, EMA’s Head of Biological Health Threats and Vaccines Strategy. A recording of the briefing is available.?
14/05/2020Fees payable to the European Medicines AgencyEMA announced that it is waiving its fees for on-site inspections of manufacturing sites and blood establishments that have been inspected remotely during the pandemic but where the remote inspection could not confirm compliance with good manufacturing practice (GMP) standards. For further details, see the
PDF icon decision of EMA’s Executive Director .?
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14/05/2020Treatments and vaccines for COVID-19EMA gave an update stating that it had been in contact with the developers of around:
  • 115 potential COVID-19 treatments;
  • 33 potential COVID-19 vaccines.
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13/05/2020EMA’s governance during COVID-19 pandemicEMA’s Executive Director, Guido Rasi, briefed the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) on EMA’s response to COVID-19 on Tuesday, 12 May. He explained EMA’s efforts to expedite the development and approval of COVID-19 treatments and vaccines, its role in ensuring the continued availability of crucial medicines in the EU during the pandemic, and its publication of reliable information for patients and healthcare professionals. A recording of the session is available on the European Parliament’s website.?
11/05/2020Treatments and vaccines for COVID-19
EMA’s CHMP recommended extending the compassionate use of the investigational medicine remdesivir to further groups of patients in Europe, based on preliminary results of studies with the medicine. The updated recommendations cover hospitalised patients who are requiring supplemental oxygen, non-invasive ventilation, high-flow oxygen devices or ECMO (extracorporeal membrane oxygenation), in addition to those on invasive mechanical ventilation.?
EMA recommends expanding remdesivir compassionate use to patients not on mechanical ventilation
08/05/2020Availability of medicines during COVID-19 pandemicEMA provided an update on the measures EU authorities are putting in place to support the continued availability of medicines during the pandemic, following a meeting of the EU Executive Steering Group on Shortages of Medicines Caused by Major Events.EU actions to support availability of medicines during COVID-19 pandemic – update #5
07/05/2020Guidance for medicine developers and other stakeholders on COVID-19EMA updated the eSubmission Gateway user interface to allow applicants to flag submissions related to COVID-19. The aim is to help EMA rapidly identify and prioritise COVID-19-related submissions. More information, including an updated user guide and release notes are available on the eSubmission website.?
05/05/2020International Coalition of Medicines Regulatory Authorities (ICMRA)EMA chaired the second bi-weekly global regulators’ meeting on COVID-19-related policy approaches and regulatory flexibility on Thursday 30 April, under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). Participants focused on the development of medicines and vaccines development against COVID-19, and stressed the need for the alignment of regulatory requirements to help speed their development, evaluation and availability.Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19
04/05/2020Guidance for medicine developers and other stakeholders on COVID-19EMA published PDF icon guidance for developers on the rapid review procedures it has put in place to speed up development and approval of COVID-19 treatments and vaccines. The rapid procedures can accelerate every step of the regulatory pathway while ensuring that robust evidence on efficacy, safety and quality is generated to support scientific and regulatory decisions. As these procedures require developers to submit well-prepared dossiers, EMA encourages them to contact the Agency as soon as possible to discuss their strategy for evidence-generation, by emailing their proposals to 2019-ncov@ema.europa.eu.?COVID-19: how EMA fast-tracks development support and approval of medicines and vaccines
04/05/2020Guidance for medicine developers and other stakeholders on COVID-19EMA updated its guidance for marketing authorisation holders on how to submit COVID-19-related individual case safety reports (ICSR) to EudraVigilance. The update of the guidance follows the implementation of version 23.0 of the Medical Dictionary for Regulatory Activities (MedDRA) containing additional COVID-19-related terms in EudraVigilance on Monday, 4 May.??
04/05/2020Guidance for medicine developers and other stakeholders on COVID-19EMA, the European Commission and the national competent authorities published questions and answers on regulatory expectations for medicinal products for veterinary use during the COVID-19 pandemic. This guidance is for pharmaceutical companies responsible for veterinary medicines and sets out the adaptations to the regulatory framework in place to address challenges arising from the COVID-19 pandemic. It covers marketing authorisation procedures, pharmacovigilance and good-manufacturing-practice (GMP) certificates, and inspections for veterinary medicines.?Regulatory flexibility to ensure availability of veterinary medicines during COVID-19 pandemic
30/04/2020Treatments and vaccines for COVID-19EMA announced that its CHMP has started a rolling review of data on the use of the investigational antiviral medicine remdesivir for the treatment of COVID-19. This means that the CHMP is assessing data as they become available on a rolling basis while development is still ongoing. This is one of the Agency's regulatory tools to speed up the evaluation of a promising investigational treatment during a public health emergency.EMA starts rolling review of remdesivir for COVID-19
30/04/2020Availability of medicines during COVID-19 pandemicEMA provided an update on the measures EU authorities are putting in place to support the continued availability of medicines during the pandemic, following a meeting of the EU Executive Steering Group on Shortages of Medicines Caused by Major Events.EU actions to support availability of medicines during COVID-19 pandemic – update #4
28/04/2020Guidance for medicine developers and other stakeholders on COVID-19EMA, the European Commission and the Heads of Medicines Agencies updated the Guidance on the management of clinical trials during the COVID-19 (coronavirus) pandemic. The updated guidance includes more recommendations on simple and flexible measures sponsors can take to manage clinical trials during the COVID-19 pandemic, given the impact it is having on European health systems and society in general.European Commission:?Coronavirus: Commission issues guidance to mitigate clinical trial disruption in the EU
28/04/2020International Coalition of Medicines Regulatory Authorities (ICMRA)EMA endorsed a joint statement by the members of the International Coalition of Medicines Regulatory Authorities (ICMRA). The statement commits the international regulators to strengthen global collaboration to facilitate rapid development, approval and roll-out of safe and effective medicines against COVID-19.International regulators pledge collective support to combat COVID-19 pandemic
24/04/2020Availability of medicines during COVID-19 pandemicEMA provided an update on the measures EU authorities are putting in place to support the continued availability of medicines during the pandemic, following a meeting of the EU Executive Steering Group on Shortages of Medicines Caused by Major Events.?This includes the development of guidance for pharmaceutical companies responsible for veterinary medicines on adaptations of the regulatory framework to address COVID-19-related challenges.EU actions to support availability of medicines during COVID-19 pandemic – update #3
24/04/2020Public-health advice during COVID-19 pandemic
EMA and the national competent authorities reminded patients with suspected or confirmed COVID-19 to report any suspected side effects that they are experiencing with any medicine, including medicines taken to treat COVID-19 and pre-existing conditions. Healthcare professionals treating COVID-19 patients should also report the suspected side effects that their patients are experiencing. These reports help regulators understand how medicines act in patients with COVID-19, complementing the knowledge generated in clinical trials and other studies.
Reporting suspected side effects of medicines in patients with COVID-19
23/04/2020EMA’s governance during COVID-19 pandemicEMA announced that essential work to combat the COVID-19 pandemic would continue during the Agency’s closure on 27 April and on 1 May 2020.Essential work to combat the COVID-19 pandemic to continue during EMA's closure on 27 April and on 1 May 2020
23/04/2020Public-health advice during COVID-19 pandemicEMA reminded patients and healthcare professionals that chloroquine and hydroxychloroquine medicines are known to potentially cause certain side effects, including heart rhythm problems. Healthcare professionals should carefully consider the possibility of heart rhythm problems when treating COVID-19 patients with these medicines, particularly in patients with pre-existing heart problems and with higher doses, and exercise extra caution when combining treatment with other medicines such as azithromycin that have similar effects on the heart.COVID-19: reminder of risk of serious side effects with chloroquine and hydroxychloroquine
21/04/2020International Coalition of Medicines Regulatory Authorities (ICMRA)EMA participated in the global regulators’ meeting on COVID-19-related policy approaches and regulatory flexibility on Thursday, 16 April, under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). Participants discussed high-level policy issues and regulatory challenges related to the rapid development of potential COVID-19 treatments and vaccines and the continued availability of medicines during the pandemic, in particular those used in intensive care. The meeting was the first of a series of bi-weekly meetings organised by ICMRA to allow medicine regulators worldwide to exchange information and build synergies for expediting COVID-19 medicine and vaccine development and approval and avoiding medicine shortages. EMA will chair every other meeting.?
21/04/2020Availability of medicines during COVID-19 pandemicEMA announced that it had launched, together with EU Member States and the pharmaceutical industry, an enhanced fast-track monitoring system to help prevent and mitigate supply issues with crucial medicines used for treating COVID-19 patients. Initially, the system will focus on medicines used in intensive care, which are in greatest demand, before extending to a broader range of medicines. The monitoring system, which involves each pharmaceutical company appointing an industry single point of contact (iSPOC), was set up by the EU Executive Steering Group on Shortages of Medicines Caused by Major Events in cooperation with pharmaceutical companies in the EU.Launch of enhanced monitoring system for availability of medicines used for treating COVID-19
21/04/2020EMA’s governance during COVID-19 pandemicEMA decided to continue holding its committee and working-party meetings virtually until the end of May 2020. Stakeholder events planned for May will either be postponed or held virtually. Most EMA staff are also continuing to work remotely until the end of May.?
20/04/2020Guidance for medicine developers and other stakeholders on COVID-19The European Commission, EMA and the Heads of Medicine Agencies updated their guidance for pharmaceutical companies on adaptations to the regulatory framework to address COVID-19 challenges to cover good manufacturing practice (GMP) and good distribution practice (GDP) inspections, and the submission of individual case safety reports (ICSRs) to EudraVigilance. EMA published PDF icon additional guidance for qualified persons for pharmcovigilance (QPPV) and marketing authorisation holders on how to submit COVID-19-related ICSRs to EudraVigilance, including on the use of the correct Medical Dictionary for Regulatory Activities (MedDRA) terms and free-text fields.Update to guidance on regulatory expectations in the context of COVID-19 pandemic
20/04/2020Availability of medicines during COVID-19 pandemicEMA provided an update on the measures EU authorities are putting place to support the continued availability of medicines during the pandemic, following a meeting of the EU Executive Steering Group on Shortages of Medicines Caused by Major Events. The update covers progress made in setting up an enhanced monitoring system for supply issues with crucial medicines for the treatment of COVID-19 and planned updates to the guidance for pharmaceutical companies on adaptations of the regulatory framework to address COVID-19-related challenges.EU actions to support availability of medicines during COVID-19 pandemic – update #2
16/04/2020International Coalition of Medicines Regulatory Authorities (ICMRA)The?International Coalition of Medicines Regulatory Authorities?published a?report?summarising the third global regulatory workshop?on the use of observational studies and real-world data in generating robust evidence on the safety and?efficacy?of COVID-19 vaccines and treatments. The report?provides a snapshot of ongoing and planned observational studies, platforms and registries in various countries and regions around the world. EMA co-chaired the meeting with Health Canada.Meeting highlights from ICMRA global regulatory workshop on COVID-19 observational studies and real world data
10/04/2020Availability of medicines during COVID-19 pandemicEMA, the European Commission and the European medicines regulatory network published guidance for companies on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic, with a particular focus on crucial medicines for use in COVID-19 patients.Guidance on regulatory requirements in the context of the COVID-19 pandemic
10/04/2020Availability of medicines during COVID-19 pandemicEMA provided an update on the measures EU authorities are putting place to support the continued availability of medicines during the pandemic. This covers the enhanced monitoring system for supply issues with crucial medicines for the treatment of COVID-19 and the guidance currently under development on the regulatory rules that could be applied with greater flexibility to help secure their continued supply.Update on EU actions to support availability of medicines during COVID-19 pandemic
09/04/2020EMA’s governance during COVID-19 pandemicEMA published the PDF icon mandate of its COVID-19 EMA pandemic Task Force (COVID-ETF). ?The Task Force is helping EU Member States and the European Commission to take quick and coordinated regulatory action on the development, authorisation and safety monitoring of treatments and vaccines intended for the treatment and prevention of COVID-19.EMA establishes task force to take quick and coordinated regulatory action related to COVID-19 medicines??
09/04/2020International Coalition of Medicines Regulatory Authorities (ICMRA)The?International Coalition of Medicines Regulatory Authorities?published the?report?summarising the second global regulatory workshop?on COVID-19 medicine development held on Thursday 2 April.?The report stresses the need for robust evidence to show which potential treatments work. EMA co-chaired the meeting.Global regulators stress need for robust evidence on COVID-19 treatments
07/04/2020International Coalition of Medicines Regulatory Authorities (ICMRA)EMA and?Health Canada?jointly chaired the third global regulatory workshop on Monday 6 April under the umbrella of the?International Coalition of Medicines Regulatory Authorities (ICMRA). The participants discussed how data generated during clinical practice in the treatment of COVID-19 could complement evidence from?clinical trials?of potential COVID-19 treatments and vaccines.Global regulators discuss observational studies of real world data for COVID-19 medicines
07/04/2020EMA’s governance during COVID-19 pandemicEMA announced that essential work to combat the COVID-19 pandemic would continue during the Agency’s Easter break from 9 to 13 April 2020.Essential work to combat the COVID-19 pandemic to continue during EMA's Easter break from 9 to 13 April 2020
06/04/2020Availability of medicines during COVID-19 pandemicEMA announced new EU-level measures to help prevent and mitigate supply issues with medicines used to treat COVID-19 patients. These include enhanced coordination with the pharmaceutical industry in monitoring supply issues and regulatory actions to support companies in increasing the available supply of critical medicines. During this extraordinary health crisis, EMA will act as the central EU coordinator, supporting Member States' activities in preventing and mitigating supply issues.EU authorities agree new measures to support availability of medicines used in the COVID-19 pandemic
03/04/2020Treatments and vaccines for COVID-19EMA’s CHMP gave recommendations on how the investigational antiviral medicine remdesivir should be used in compassionate use programmes across Europe when treating COVID-19 patients who are not eligible for inclusion in clinical trials. These recommendations aim to ensure a harmonised approach across EU Member States. They also explain which group of patients may benefit from treatment and provide preliminary information on the medicine’s safety.EMA provides recommendations on compassionate use of remdesivir for COVID-19
03/04/2020International Coalition of Medicines Regulatory Authorities (ICMRA)EMA and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) jointly chaired the second global regulatory workshop on Thursday 2 April under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). The participants discussed the progress made in the development of potential COVID-19 treatments and reaffirmed the need for large clinical trials to generate conclusive evidence on which treatments work. ICMRA will publish a summary report of the meeting shortly.International regulators discuss available knowledge supporting COVID-19 medicine development
01/04/2020Public-health advice during COVID-19 pandemicEMA advised patients and healthcare professionals to only use chloroquine and hydroxychloroquine medicines for their authorised indications or as part of clinical trials or national emergency use programmes for the treatment of COVID-19. This is to ensure patient safety and the best use of available supplies.COVID-19: chloroquine and hydroxychloroquine only to be used in clinical trials or emergency use programmes
31/03/2020Treatments and vaccines for COVID-19EMA announced that it has held discussions with developers of around 40 potential treatments and a dozen vaccines against COVID-19. No potential COVID-19 treatments had demonstrated efficacy based on the preliminary data available. EMA welcomes the launch of large clinical trials to test promising treatments and to generate conclusive evidence. Two vaccines had already entered phase I clinical trials. EMA estimated that it might take at least a year before a vaccine is ready for approval and available in sufficient quantities to enable widespread use.?Update on treatments and vaccines against COVID-19 under development
30/03/2020Certification of medicinal productsEMA started issuing certificates that are signed and authenticated electronically in place of paper certificates. This applies to all ongoing and future requests for certificates during the COVID-19 pandemic.EMA to issue electronic certificates for medicines
27/03/2020Guidance for medicine developers and other stakeholders on COVID-19EMA, the European Commission and the?Heads of Medicines Agencies?updated the?Guidance on the management of clinical trials during the COVID-19 (coronavirus) pandemic?to cover?safety reporting, the distribution of in-vitro diagnostics, medical devices and auditing.?The updated guidance also incorporates changes in other sections, in particular on communicating with authorities, informed consent and the distribution of investigational medicines.?
27/03/2020Public-health advice during COVID-19 pandemicEMA advised patients and healthcare professionals that angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs, or sartan medicines) can continue to be used to treat high blood pressure, heart failure or kidney disease during the COVID-19 pandemic. There is currently no evidence from clinical or epidemiological studies that establishes a link between these medicines and worsening of COVID-19. Patients taking these medicines should not interrupt their treatment without speaking to their doctor or pharmacist first. EMA will keep its information on new COVID-19-related treatment recommendations up to date.EMA advises continued use of medicines for hypertension, heart or kidney disease during COVID-19 pandemic
27/03/2020Treatments and vaccines for COVID-19EMA and the?European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP)?encouraged all researchers to register their pharmacoepidemiological studies related to the COVID-19 pandemic in the?EU PAS Register. They should also upload and make their study protocols public, with a description of the data collected or planned to be collected. This is to facilitate collaborations and speed up the design of observational studies by others. Researchers should include ‘COVID-19’ in the study title to allow easy retrieval of all COVID-19-related studies via the ‘Title of Study’ search filter.?
25/03/2020Guidance for medicine developers and other stakeholders on COVID-19EMA published?guidance on the actions that sponsors of ongoing clinical trials affected by the COVID-19 pandemic should take?to help ensure the integrity of their studies and the interpretation of study results while safeguarding the safety of trial participants as a first priority.?This complements the?good clinical practice guidance?on how sponsors should adjust the management of clinical trials?and participants during the pandemic.??
24/03/2020International Coalition of Medicines Regulatory Authorities (ICMRA)The?International Coalition of Medicines Regulatory Authorities?published a?summary report?of?the first global regulatory workshop on COVID-19 vaccine development which was co-chaired by EMA.?The report focuses on pre-clinical data requirements and?the?theoretical risk that vaccines against COVID-19 enhance the disease prior to starting first-in-human?clinical trials.Global regulators map out data requirements for phase 1 COVID-19 vaccine trials
24/03/2020Availability of medicines during COVID-19 pandemicSome Member States are experiencing medicine shortages due to an increased demand for some medicines. This is either because the medicines are used to treat COVID-19 patients or because patients are requesting more than their usual supplies.?In order to prevent unnecessary strain on supply chains, patients should only receive their usual supply of medicines.?For information on ongoing medicine shortages in the EU, patients and healthcare professionals can check the relevant?national shortages registers?and EMA's?shortages catalogue.?
24/03/2020Buying medicines onlineEMA urged patients to beware of potential?falsified medicines?sold by unregistered websites and vendors. These vendors may be exploiting fears during the COVID-19 pandemic and claiming that their products can prevent or cure COVID-19. They may also appear to provide easy access to medicines that are otherwise not readily available. Patients can stay safe when buying medicines online by following?EU advice.?COVID-19: Beware of falsified medicines from unregistered websites
20/03/2020Guidance for medicine developers and other stakeholders on COVID-19The European Commission, EMA and the Head of Medicines Agencies?provided?guidance for sponsors?on how they should adjust the management of?clinical trials?and participants during the COVID-19 pandemic. It covers how to deal with the extraordinary situations the pandemic presents and includes specific advice on?clinical trials?for COVID-19 treatments.Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic
20/03/2020EMA’s governance during COVID-19 pandemicEMA’s?first Management Board meeting of 2020?took place virtually and was reduced to one and a half hours to allow EMA and the Member States to continue to focus resources on the response to the pandemic.EMA Management Board – highlights of March 2020 meeting
19/03/2020Guidance for medicine developers and other stakeholders on COVID-19EMA's Committee for Medicinal Products for Human Use (CHMP) urged the EU research community to prioritise large randomised controlled clinical studies as these are most likely to generate the conclusive evidence needed to enable rapid development and approval of potential COVID-19 treatments. They also emphasised the need to include all EU countries in these trials. EMA is currently engaging with stakeholders who can further support the conduct of clinical trials across Europe.Call to pool research resources into large multi-centre, multi-arm clinical trials to generate sound evidence on COVID-19 treatments
18/03/2020International Coalition of Medicines Regulatory Authorities (ICMRA)The first global regulatory workshop on COVID-19?was convened under the umbrella of the?International Coalition of Medicines Regulatory Authorities. Co-chaired by EMA?and the US?Food and Drug Administration, it brought together delegates from 17 countries and experts from the?World Health Organization?and the?European Commission?to discuss the development of vaccines against COVID-19.?First regulatory workshop on COVID-19 facilitates global collaboration on vaccine development
18/03/2020Public-health advice during COVID-19 pandemicEMA advised patients and healthcare professionals that there?currently no scientific evidence establishing a link between ibuprofen and worsening of COVID 19. However, EMA calls for further studies, which it is ready to support. Patients and healthcare professionals should consider all available options for treating coronavirus symptoms, including paracetamol and NSAIDs, in line with the product information and national guidelines.EMA gives advice on the use of non-steroidal anti-inflammatories for COVID-19
18/03/2020EMA’s governance during COVID-19 pandemicEMA announced that it will participate?as observer in the European Commission's advisory panel on COVID-19. Chaired by Commission President Ursula von der Leyen and co-chaired by Stella Kyriakides, Commissioner for Health and Food Safety, the panel of European scientific experts will formulate EU guidelines for science-based and coordinated risk-management measures.?
17/03/2020EMA’s governance during COVID-19 pandemicAs of 16 March 2020, most EMA staff are working remotely. This is expected to last until the end of April 2020.??
13/03/2020Guidance for medicine developers and other stakeholders on COVID-19EMA provides?full fee waivers for scientific advice?for potential?vaccines and?treatments for COVID-19. Developers of potential therapeutics or vaccines against COVID-19 are invited to contact the Agency as soon as possible with information about their proposed development, by emailing?2019-ncov@ema.europa.eu.?COVID-19: developers of medicines or vaccines to benefit from free scientific advice
11/03/2020EMA’s governance during COVID-19 pandemicEMA announced that is holding all its committee and working party meetings virtually until the end of April 2020. Other EMA-hosted stakeholder events will either be held virtually or postponed until later in 2020. EMA has also initiated its business continuity plan for the effective management of the COVID-19 crisis. These measures do not impact EMA’s core activities.COVID-19: EMA meetings with delegates and experts will be held virtually until end April 2020
10/03/2020Availability of medicines during COVID-19 pandemicThe European medicines regulatory network has taken measures to monitor the potential impact of the outbreak of COVID-19 on human and veterinary medicine supply chains in the EU. This includes working with pharmaceutical industry associations, companies and manufacturers in the EU to assess the resilience of supply chains.Addressing the potential impact of novel coronavirus disease (COVID-19) on medicines supply in the EU
04/02/2020Guidance for medicine developers and other stakeholders on COVID-19EMA encouraged developers of potential vaccines or treatments?for novel coronavirus disease (COVID-19) to make use of the Agency's?regulatory mechanisms to speed up development and approval?and?to contact EMA as soon as possible to discuss their strategy for evidence-generation, by emailing?2019-ncov@ema.europa.eu.?EMA has activated its?plan for managing emerging health threats.EMA to support development of vaccines and treatments for novel coronavirus disease (COVID-19)

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