ARTICLE | Regulation

Fewer obligations, increased uptake of Europe’s conditional approval pathway

More companies seek approval via the expedited route as EMA changes its attitude toward risk

September 1, 2021 1:12 PM UTC

Early experience with EMA’s conditional approval process led to the perception that the additional rigors of Europe’s conditional marketing authorization pathway — annual renewals and tighter timelines for postmarket data submission — led companies to preferentially seek a standard MAA over the expedited route.

Data from the past three years suggest the tide has turned...

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