EMA: European Medicines Agency

What is the EMA?

The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU) responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU. The mission of the European Medicines Agency (EMA) is to foster scientific excellence in the evaluation and supervision of medicines, for the benefit of public and animal health in the European Union (EU).

EMA is committed to enabling timely patient access to new medicines, and plays a vital role in supporting medicine development for the benefit of patients. The Agency uses a wide range of regulatory mechanisms to achieve these aims, which are continuously reviewed and improved.

EMA plays a role in supporting research and innovation in the pharmaceutical sector, and promotes innovation and development of new medicines by European micro-, small- and medium-sized-enterprises.

EMA also has responsibilities for monitoring and mitigating potential or actual shortages of critical medicines caused by major events and in crisis situations.

Engaging patients and consumers

The European Medicines Agency (EMA) and patients have been actively interacting since the creation of the Agency in 1995. This cooperation was extended to include consumer groups with an interest in medicines. Both of these stakeholder groups bring a ‘real-life’ experience as well as specific knowledge and expertise to scientific discussions on medicines and on the impact of regulatory decisions. Collaborating with these groups supports transparency and improves regulatory processes within the EMA.

The framework for engagement between EMA and patients and consumers and their organisations outlines the basis for involving patients and consumers in Agency activities.

Patients and consumers are involved in a wide range of activities at the Agency, including:

  • as members of the Management Board
  • as members of scientific committees
  • being consulted on disease-specific requests by the scientific committees and working parties
  • taking part in discussions on the development and authorisation of medicines
  • reviewing written information on medicines prepared by the Agency
  • being involved in the preparation of guidelines
  • taking part in the Agency’s conferences and workshops

The role of EFCNI within EMA

EFCNI has been collaborating with EMA for over ten years and has provided input to several of the above activities. These include reviewing written information on medicines and providing input on specific diseases.

Most recently, in 2022, EFCNI was selected to be a member of the EMA’s Patient and Consumer Working Party (PCWP) for the 2022 – 2025 mandate. The Patients’ and Consumers’ Working Party (PCWP) provides a platform for exchange of information and discussion of issues of common interest between EMA and patients and consumers.

The PCWP provides recommendations to the EMA and its Human Scientific Committees on matters of direct or indirect interest to patients in relation to medicines for human use and monitor the overall interactions between EMA and patients and consumers. The PCWP will facilitate EMA’s dialogue and exchange with patient and consumer organisations on relevant issues related to medicines for human use within the European legal framework. Through the PCWP, EMA will inform and will obtain input and feedback from patients and consumers on various EMA activities. Ultimately, the PCWP is expected to contribute to EMA’s strategic goal of advancing public health by supporting its initiatives to bringing real-life data into regulatory science and promoting a safer and more rational use of medicines.

As a member of the PCWP, EFCNI will contribute to topics such as digital health, information on/about medicines, vaccines, patient data and visibility of the patient contribution to EMA activities as well as many other topics that are still to be defined. EFCNI will be represented at at least two meetings per year of the PCWP.

EFCNI has joined a call to EMA to declare the current shortage of antibiotics in the EU a „major event“. Have a look at the letter addressed to the EMA and co-signed by EFCNI.