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Drug regulators agree approval processes must be better aligned

Urgency of cross-border Covid-19 trials means authorisation requirements must be compatible, regulators say

Medicines agencies around the world have agreed they must better align their pre- and post-authorisation regulatory requirements so that decentralised trials of Covid-19 treatments can progress at top speed.

In a meeting summarised by the European Medicines Agency on 5 May, regulators also said it was crucial to use common study protocols so results can be pooled and used to win approval.

The meeting came as parallel and linked trials of potential treatments for Covid-19 continue across Europe. The EMA will fast-track the approval of such drugs and is trying to take a more flexible approach to approvals generally.

The EMA said regulators are still concerned that multiple small trials of potential Covid-19 treatments are taking place, rather than more meaningful larger trials.