Posted by Michael Wonder on 14 Sep 2018
EMA Priority Medicines scheme (PRIME): will more paying-for-performance agreements be needed due to immature data?
14 September 2018 - The EU’s centralized procedure for the authorization of a new drug is performed by the EMA.
This well-known process requires the analysis of a large amount of data generated by clinical trials, as well as from other sources.
As HTA agencies are also common in many EU countries, their assessments may also be requested by some institutions before adopting decisions about the introduction of a new drug in the public service catalog. In total, since the application for the centralised authorisation by EMA until the drug can be prescribed to a given patient, the process can easily take 24 months, and sometimes even longer.
