EMA is the European Medicines Agency decentralised of the European Union. EMA is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union.

Since 2010, EUnetHTA and EMA have been in regular contact to exchange information and discuss various issues of mutual interest.

The cooperation started with a project on improving EPARs followed by discussions and concrete cooperation on the following topics:

  • databases for post-licensing studies;
  • new EU Pharmacovigilance legislation;
  • significant benefit for orphan medicinal products;
  • EUnetHTA’s rapid model for Relative Effectiveness Assessment of Pharmaceuticals (pilot and future developments; i.e. possibilities to streamline the timelines of rapid pilots with EMA assessments);
  • early scientific advice; EMA-HTA scientific advice, and multi-HTA scientific advice;
  • regulatory and HTA methodological guidelines

Discussions take place at the bi-annual meetings between the EUnetHTA and EMA representatives, via participation of EMA as observer in relevant activities of the EUnetHTA Joint Actions (2010-2012 and 2012-2015), by mutual commenting on specific documents produced by either of the organisation.

EUnetHTA and its members participate in the EMA-supported ENCePP network.

Press releases:

EUnetHTA-EMA meetings:

Read more about EMA

EMA