The European Medicines Agency (EMA) hosted an awareness session to present the European Union’s (EU) medicines regulatory system and EMA’s role in it to international regulators and non-governmental organisations.
All the speakers were part of the Agency and will present on the European medicines regulatory network and the various activities carried out by EMA as part of it. The issue will be to show a clear understanding of how medicines are regulated in different parts of the word is of prime importance in an increasingly globalised world where regulators rely on close cooperation.
- European Union (EU) marketing authorisation procedures
- Support to innovation
- Benefit/risk assessment of new medicines
- Pharmacovigilance activities
- Stakeholder engagement
The European medicines regulatory system is based on a network of around 50 regulatory authorities from the 31 EEA countries (28 EU Member States plus Iceland, Liechtenstein and Norway), the European Commission and EMA.
This network is what makes the EU regulatory system unique. The network is supported by a pool of thousands of experts drawn from across Europe, allowing it to source the best possible scientific expertise for the regulation of medicines in the EU and to provide scientific advice of the highest quality.
EMA and the Member States cooperate and share expertise in the assessment of new medicines and of new safety information. They also rely on each other for exchange of information in the regulation of medicine, for example regarding the reporting of side effects of medicines, the oversight of clinical trials and the conduct of inspections of medicines’ manufacturers. This works because EU legislation requires that each Member State operates to the same rules and requirements regarding the authorisation and monitoring of medicines.
For more information, please see the programme.