EMA
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:
- Press release 13 November 2017: On Joint Work Plan 2017-2020. Find the work plan here
- Press release 4 July 2017: On joint platform for parallel consultation. Find the guidelines here
- Press release 14 April 2016: On implementation of the joint work plan covering the period between November 2012 and December 2015. Find the implementation report here
- Press release 24 June 2014: Joint EMA-EUnetHTA press release on the publication of the article “Improving the contribution of regulatory assessment reports to health technology assessments – a collaboration between the European Medicines Agency and the European network for Health Technology Assessment” in Value in Health, the Journal of The International Society For Pharmacoeconomics And Outcomes Research.
- Press release 19 November 2013: On the EMA-EUnetHTA 3-year work plan. Find the work plan here.
- Press release May 14, 2013: On the EMA-EUnetHTA meeting in London, UK to review the progress of collaboration.
- Press release 16 February 2010: Collaboration on improving EPARs.
EUnetHTA-EMA meetings:
- EUnetHTA-EMA face-to-face meeting summary, 5 July 2018, Amsterdam, Netherlands
- EUnetHTA-EMA face-to-face meeting summary, 15 December 2017, London, UK
- EUnetHTA-EMA face-to-face meeting summary, 8 June 2017, Diemen, the Netherlands
- EUnetHTA-EMA face-to-face meeting summary, 7 December 2016, London, UK
- EUnetHTA-EMA face-to-face meeting summary, 23 November 2015, Copenhagen, Denmark
- EUnetHTA-EMA face-to-face meeting summary, 8 May, 2015, London, UK
- EUnetHTA-EMA face-to-face meeting summarry, 9 December 2014, Diemen, the Netherlands
- EUnetHTA-EMA face-to-face meeting summary, 12 May, 2014, London, UK
- EUnetHTA-EMA face-to-face meeting summary, 10 December, 2013, Cologne, Germany
- EUnetHTA-EMA face-to-face meeting summary, 14 May, 2013, London UK
- EUnetHTA-EMA face-to-face meeting summary, 20 November 2012, Copenhagen Denmark
- EUnetHTA-EMA face-to-face meeting summary, 22 February, 2012, Paris France
- EUnetHTA-EMA face-to-face meeting summary, 7 March, 2011, Diemen Netherlands
- EUnetHTA-EMA face-to-face meeting summary, 3 June, 2010, London UK
- EUnetHTA-EMA face-to-face meeting summary, 11 February, 2010, London UK
