Posted by Michael Wonder on 26 Oct 2018
Does fast-track drugs approval in EU run too fast?
25 October 2018 - In 2017, only 7 out of 92 medicines received a recommendation for marketing authorisation following an EU accelerated assessment procedure. Under the US counterpart scheme 18 out of 46 medicines were authorised in the same time period.
More than two years after its launch, the EU’s fast-track approval process for marketing new drugs, called PRIME, is broadly welcomed by patients and industry, walking the fine line between patients’ safety and expediency, and between the need to foster innovation and remaining abuse-proof.
What remains problematic is the “conditional market authorisation,” another procedure that was introduced before PRIME, because of additional data requirements after the approval.
