A central pillar in the European Medicines Agency's (EMA) strategy to protect public health is the strengthening of collaboration at international level to promote harmonisation of regulatory requirements, sharing of information and addressing common challenges.
Approximately 80% of all active substances in the medicines used in Europe come from outside the European Union (EU).
Manufacturing phases of a medicine may now be carried out in different countries or even different continents, and a medicine may often be distributed in multiple regions. In addition, clinical trials supporting the authorisation of medicines in the EU take place in increasing number of different countries around the world.
In this globalised context, international cooperation among medicine regulators has become key to supervising complex supply chains and avoiding duplication of regulatory work to make best use of resources.
EMA's international cooperation activities aim to:
- ensure the quality of medicines and the integrity and security of the supply chain;
- ensure the integrity of data used to support clinical trials and manufacturing;
- encourage a global approach to authorisation and supervision of medicines;
- promote effective use of global regulatory resources by avoiding unnecessary duplication of efforts;
- streamline public communication on common topics.
Trends in international cooperation
International cooperation is moving from harmonisation of technical requirements towards a more convergence-based approach, emphasising information and work-sharing through multilateral cooperation and coalitions.
International agreements are the basis for current change in the model of collaboration, allowing not only sharing of information but also addressing common challenges.
The Agency's international strategy promotes:
- mutual reliance and work-sharing with other international authorities;
- training and capacity-building in countries with less-developed regulatory systems;
- convergence of global standards in global regulatory fora.
It also offers its expertise to support countries with less regulatory experience and infrastructure, reinforcing its role as a global reference authority which provides the oversight expected by citizens in the EU and worldwide.