Agency cites “increasing volume” of pandemic-related treatment assessments
The EU’s medicines regulator has taken extra steps to prioritise its work on Covid-19, by temporarily relaxing requirements on assessments of treatments for other diseases.
The European Medicines Agency announced on 11 May that it was “implementing additional temporary measures to further streamline activities…to enable experts to deal with an increasing volume of Covid-19-related assessment procedures”.
It said that, with certain exceptions, applications for initial marketing authorisations for non-Covid treatments will not undergo two separate assessments in the first phase of their evaluation. Instead, the second assessor will merely critique the primary assessor’s work, freeing up some of the former’s time.
Other temporary measures include dropping the use of a “separate, formally appointed peer reviewer” for all assessments, to instead rely only on the “intrinsic peer review” that is part of its approval committee’s evaluation process.
The changes will come into effect this month, the agency said.