EMA Signs 3-Year Work Plan with EUnetHTA

Published on: 

Plan outlines key areas of collaboration.

The European Medicines Agency ( EMA) and the European network for Health Technology Assessment (EUnetHTA) have published a joint work plan outlining key areas of collaboration. This initiative follows a commitment made by both organisations during a meeting in May 2013. The publication will focus on data generation that supports decision making by regulators and HTA assessment agencies. Both EMA and EUnetHTA will review the work plan on an ongoing basis and update it if required.

The key areas for the next three years include:

— Scientific advice and early dialogue with sponsors, involving medicines regulators and health-technology assessment (HTA) bodies;

— Exchange on the development of scientific and methodological guidelines to facilitate clinical-trial design that can generate data relevant for both benefit-risk and relative effectiveness assessments;

— Developing approaches for collection of post-authorisation data to support activities of both medicines regulatory authorities and HTA bodies;


— Orphan medicinal products, exploring ways of sharing information for the common benefit of patients affected by rare diseases and the financial sustainability of the healthcare systems.

EMA and EUnetHTA started collaborating in 2010 with the aim of addressing recommendations by a group of European policy makers, i.e., the Pharmaceutical Forum , as well as to improve the use of benefit-risk assessment data published by EU regulators to better address the needs of HTA organisations. The template of the European assessment report has seen a series of improvements since then. EMA and EUnetHTA are in the process of publishing the outcome of this project in more detail. Both organisations will be holding another meeting in December 2013 and the minutes of the meeting will be available on their websites.

Source: EMA, EUnetHTA