The pharmaceutical industry is one of the European Medicines Agency's (EMA) main stakeholders. Interacting with pharmaceutical companies has been a major part of EMA's daily business since it began operating. These interactions are guided by a formal framework that rests on the principles of accountability, transparency and broad representation.
EMA routinely interacts with pharmaceutical companies through various channels, including:
- overseeing the centralised authorisation procedure, whereby pharmaceutical companies apply for a single marketing authorisation valid throughout the European Union (EU);
- providing scientific advice to companies to support research and development activities;
- offering targeted information to micro, small and medium-sized enterprises (SMEs);
- advising on compliance with EU regulatory requirements.
For certain activities, EMA charges pharmaceutical companies administrative fees. The bulk of the income from fees is redistributed among European Member States who provide the scientific expertise for assessing regulatory applications. For more information, see Fees payable to the EMA.
EMA also regularly discusses topics with industry representatives in the context of public health, including:
- the implementation and operational impact of new legislation and scientific guidelines;
- procedural and/or organisational developments at EMA, including policies such as those on transparency and public access to information;
- the latest scientific advances in medicine.
The Corporate Stakeholders Department, set up in 2014, acts as a central contact point dedicated to consolidating, streamlining and coordinating EMA's relations and communication activities with pharmaceutical industry associations. Industry representatives can write to email@example.com.
The framework for interaction with industry stakeholders formalises and structures interactions with pharmaceutical industry associations active in the human and veterinary medicines. It defines the following objectives:
- provide a platform to exchange views and promote dialogue with stakeholders on topics concerning medicines for human and veterinary use;
- improve communication and provide efficient, targeted and timely information in a proactive manner;
- enhance stakeholders' understanding of the EU medicines regulatory framework and the role of the regulators and enrich the EMA's understanding of issues that are pertinent from the industry perspective for product development and licensing;
- build on existing interactions between industry (including SMEs), academia and other stakeholders in the overall science, medicines, and healthcare arenas by co-operating with established networks and alliances;
- increase transparency of stakeholders engaging with the EMA and report on the interaction.
The framework takes account of the general principles for stakeholder consultation outlined in the European Commission's staff working document on 'Better Regulation Guidelines', adopted in May 2015. EMA's Management Board endorsed the framework for interaction in October 2015:?
EMA will undertake regular surveys to monitor the implementation of this framework and will publish a report on the progress of interacting with industry stakeholders annually.
The framework is in line with EMA's overarching framework for stakeholder relations management, which the EMA Management Board adopted in June 2016:
Reports of EMA interactions with industry stakeholders
2018-2019 biennial report
on its interactions with industry stakeholders.
For previous reports, see:
Any industry organisation and association may register as an interested party by writing to firstname.lastname@example.org. This allows them to receive information and notices of written consultations in selective areas of interest.
To be more directly involved in Agency activities, industry stakeholders will need to be deemed eligible for engaging in consultative dialogue and cooperating with Agency in specific areas.
Any not-for-profit industry organisation that fulfils the following eligibility criteria may apply:
- legitimacy, with statutes registered in the EU or European Economic Area (EEA);
- clear mission and objectives and an interest in human or veterinary medicines;
- registered in the European Commission EU Transparency registry;
- being representative of all its members and affiliations throughout the EU/EEA;
- adequate structure.
For full details, see:
- Criteria to be fulfilled by industry stakeholder organisations involved in EMA activities
- Application form for the involvement of industry stakeholder organisations in EMA activities
The eligibility criteria came into effect in January 2017. For the list of eligible organisations, see:
Compliance with the Agency's conflicts of interests policy continues to be pivotal to the Agency's accountability and governance for engagement with all of its stakeholders. Representatives of the pharmaceutical industry cannot be members of EMA's Management Board or be represented on any of EMA's seven scientific committees.
The report summarises the outcome of the 2015 EMA survey of industry stakeholders on centralised post-authorisation Type IB and Type II variations and PSUR procedures.