Guidance for medicine developers and other stakeholders on COVID-19
The European Medicines Agency (EMA) is providing guidance for medicine developers and pharmaceutical companies to help speed up medicine and vaccine development and approval for COVID-19, and on how they should address the?regulatory challenges?arising from?the COVID-19 pandemic.
Guidance for developers of COVID-19 medicines in the research and development phase.
Guidance for developers of COVID-19 medicines preparing to submit data to EMA for evaluation.
Guidance on post-authorisation monitoring of COVID-19 medicines.
Guidance is available for clinical-trial sponsors on how they should adjust the management of clinical trials and participants during the COVID-19 pandemic.?This covers concrete changes and protocol deviations for dealing with extraordinary situations, such as the need for isolating participants, limited access to public spaces and the reallocation of healthcare professionals:
Guidance is also available on the?actions?that?sponsors?of affected clinical trials should take to help ensure the integrity of their studies and the interpretation of the study results while safeguarding the safety of trial participants as a first priority.
EMA revised this guidance on 29 June 2020 following a four-week public consultation.
For inspectors, guidance on how to initiate and conduct good clinical practice inspections remotely during the pandemic is also available:
Guidance is available for companies responsible for human medicines 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:
- Notice to stakeholders: Questions and answers on regulatory expectations for medicinal products for human use during the COVID-19 pandemic
The guidance covers:
- marketing authorisation and regulatory procedures;
- the manufacturing and importation of active substances and finished products;
- an exceptional change management process (ECMP);
- quality variations;
- labelling and packaging requirements;
- good manufacturing practice (GMP) and good distribution practice (GDP) certificates and inspections;
- pharmacovigilance?inspections,?system audits and corrective and preventive actions (CAPAs);
- submitting?individual case safety reports (ICSR) to EudraVigilance.
Companies should note that some of the measures described in the guidance are reserved for crucial medicines used for treating COVID-19 patients.
The guidance?was agreed by EMA, the European Commission, the European medicines regulatory network and endorsed by the EU Executive Steering Group on Shortages of Medicines Caused by Major Events.?
Additional guidance is available for?marketing authorisation holders on submitting COVID-19-related ICSRs to EudraVigilance, including on the?correct use of COVID-19-related terms of version 23.0 of the Medical Dictionary for Regulatory Activities (MedDRA):
Guidance is available for companies responsible for veterinary?medicines on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic:
- Notice to stakeholders: Questions and answers on regulatory expectations for medicinal products for veterinary?use during the COVID-19 pandemic
The guidance covers:
- marketing authorisation procedures;
- pharmacovigilance, including pharmacovilance inspections;
- good manufacturing practice (GMP)?certificates and inspections;
The guidance was agreed by EMA, the European Commission, the European medicines regulatory network and endorsed by the EU Executive Steering Group on Shortages of Medicines Caused by Major Events. It was first published on 30 April 2020.
The guidance was updated on 1 July 2020 to cover pharmacovigilance inspections.
Further updates to this guidance are possible?as the pandemic develops.