Bilateral interactions with non-EU regulators

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The European Medicines Agency cooperates with many of the world’s largest regulatory bodies outside the European Union (EU) in areas such as inspections, safety of medicines and exchange of information on issues of mutual concern.

In an increasingly globalised pharmaceutical market and a world in which public health issues go beyond national borders, cooperation among medicine regulators has become key to supervising complex supply chains and avoiding duplication of regulatory work and make best use of resources.

International agreements are the basis for current model of collaboration, allowing not only sharing of information but also sharing of work. 

In cooperating with non-EU regulators, EMA focuses on mutual reliance and work-sharing and training and capacity-building in countries with less-developed regulatory systems.

Promoting awareness of EU regulatory system (new)

EMA organised an awareness session in September 2017 to present the European medicines regulatory network and EMA’s role in it to international regulators and non-governmental organisations (NGO):

Further information and materials are available on the meeting page. 

Sixty regulators from non EU-European, African, Asian and American countries and several international NGOs attended the session.

Based on positive feedback, EMA is planning to organise further sessions, if possible twice a year.

Bilateral interactions with non-EU regulators

The Agency has agreements in place with regulators including:

The Agency supports the European Commission's collaboration on pharmaceuticals with:

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