While it is still early days, the European Medicines Agency’s adoption of a stricter policy regarding requests by companies for extended clock-stops during the review of their initial marketing authorization applications (MAA) is yielding positive outcomes.
EMA’s Tougher Stance On Substandard Filings Shows Early Success
Insight obtained by the Pink Sheet relating to the European Medicines Agency’s stricter approach to requests for clock-stop extension shows that refusals have not led to any companies withdrawing their marketing applications. On the contrary, companies were able to provide responses within the agreed timeframe after all.
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