Focus on data generation that supports decision making by both regulators and health-technology assessment bodies
The European Medicines Agency (EMA) and EUnetHTA, the European network for Health Technology Assessment, today published a joint three-year work plan outlining key areas of collaboration. The publication of the work plan follows a commitment made at their May 2013 meeting, which reviewed the progress of their cooperation.
- scientific advice/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.
The EMA and EUnetHTA will review and update the work plan as necessary, and at least once annually.
More on EMA-EUnetHTA collaboration
The collaboration between the EMA and EUnetHTA started in 2010 to address recommendations by the Pharmaceutical Forum, a high-level group of European policy makers, to improve the way data published by EU regulators as part of their benefit-risk assessment contribute to relative effectiveness assessments by HTA organisations. The EMA and EUnetHTA started a project in the same year that looked specifically into how the information on the benefits and risks of a medicine contained in European public assessment reports (EPARs) could better address the needs of HTA organisations. The project has resulted in a series of improvements to the EPAR template. The EMA and EUnetHTA are in the process of publishing the outcome of this project in more detail.
The next meeting between the EMA and EUnetHTA will be held in December 2013. Minutes of the meeting will be published on the EMA and EUnetHTA websites following the meeting.