The European Medicines Agency has signed a three-year work plan with EUnetHTA, the network covering the continent’s health technology assessment bodies such as NICE.
The organisations have been working together since 2010 and say they will build on that collaboration “in key areas”. These include offering “scientific advice [and] early dialogue” with drugmakers and developing guidelines for clinical-trial design “that can generate data relevant for both benefit-risk and relative effectiveness assessments”.
The EMA and EUnetHTA will look to develop approaches for collection of post-authorisation data to help regulators and HTA bodies and exploring ways of sharing information on orphan drugs “for the common benefit of patients affected by rare diseases and the financial sustainability of the healthcare systems”.
The two groups note that they have been working on a project that looks “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”. They claim that this scheme has already resulted in “a series of improvements to the EPAR template” and they 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 next month.
