Posted by Michael Wonder on 07 May 2017
Conditional approval of medicines by the EMA
2 May 2017 - The process fails to improve the evidence after early licensing.
Like other expedited procedures for early marketing authorisation, conditional approval stems from the assumption that immediate availability of new drugs offers patients a benefit that outweighs the risks of limited clinical information.
To some extent, this assumption applies to all licensed drugs, but early approval magnifies the need for “managing the unknown.”
