The system for regulating medicines in Europe is unique in the world. It is based on a closely-coordinated regulatory network of national competent authorities in the Member States of the European Economic Area (EEA) working together with the European Medicines Agency (EMA) and the European Commission.
The European medicines regulatory network is the cornerstone of EMA's work and success. The Agency operates at the heart of the network, coordinating and supporting interactions between over fifty national competent authorities for both human and veterinary medicines.
These national authorities supply thousands of European experts to take part in EMA's scientific committees, working parties and other groups.
For a list of national competent authorities in the EEA, see:
The regulatory network also includes the European Commission, whose principal role in the European system is to take binding decisions based on the scientific recommendations delivered by EMA.
By working closely together, this network ensures that safe, effective and high-quality medicines are authorised throughout the European Union (EU), and that patients, healthcare professionals and citizens are provided with adequate and consistent information about medicines.
Benefits of the network for EU citizens
- Enables Member States to pool resources and coordinate work to regulate medicines efficiently and effectively;
- Creates certainty for patients, healthcare professionals, industry and governments by ensuring consistent standards and use of best available expertise;
- Reduces the administrative burden through the centralised authorisation procedure, helping medicines to reach patients faster;
- Accelerates the exchange of information on important issues, such as the safety of medicines.
The European medicines regulatory network gives EMA access to experts from across the EU, allowing it to bring together the best-available scientific expertise in the EU for the regulation of medicines.
The diversity of the experts involved in the regulation of medicines in the EU encourages the exchange of knowledge, ideas and best practices between scientists striving for the highest standards for medicines regulation.
These European experts serve as members of the Agency's scientific committees, working parties or in assessment teams supporting their members. They can be nominated by Member States or by the Agency itself and are made available by the national competent authorities.
The Agency maintains a public European expert list containing details on all experts who can be involved in EMA work. Experts can only be involved once the Agency has assessed their declaration of interests.
Multinational assessment teams (new)
EMA and its regulatory network partners run a scheme to enable multinational teams to assess applications for human and veterinary medicines. The aim is to mobilise the best expertise for medicines evaluation, regardless of where experts are based.
EMA has encouraged the formation of multinational assessment teams since 2013 for initial marketing authorisation applications.
The concept enables rapporteurs and co-rapporteurs for EMA's scientific committees to include experts from other Member States in their assessment teams. This helps to optimse resource use across the regulatory network and encourage cross-border fertilisation of scientific expertise.
The scheme began with co-rapporteur assessment teams for human medicines (CHMP and CAT), then expanded to rapporteur assessment teams, veterinary medicines (CVMP) and scientific advice procedures.
From April 2017, multinational teams can also evaluate certain post-authorisation applications to extend existing marketing authorisations.
For more information, see:
EMA and the national authorities depend on standards, processes and Information Technology (IT) systems that allow important information on medicines to be shared between European countries and analysed together.
Some of the data are supplied by the Member States and centrally managed by EMA. This supports an exchange of information on a number of issues, including:
- suspected side effects reported with medicines;
- the oversight of clinical trials;
- inspections to check compliance with good practice in the clinical development, manufacturing and distribution, and safety monitoring of medicines.
This helps to reduce duplication and supports efficient and effective regulation of medicines across the EU.
For more information on the IT systems EMA manages together with the EU Member States, see EU Telematics.
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