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EU Industry Wants ‘More Fluid’ Accelerated Assessment Procedure At EMA

 
• By Neena Brizmohun

EFPIA says that the European Medicines Agency’s fast-track regulatory review mechanism can be perceived by sponsors as being “hard to get and easy to lose.”

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The accelerated assessment procedure can cut the time it takes to review a drug marketing application • Source: Shutterstock

European pharmaceutical industry federation EFPIA says it would like to see enhancements made to the accelerated assessment procedure that the European Medicines Agency uses to speed up its review of EU marketing authorization applications (MAAs) for certain drugs.

The fast-track status can be perceived by sponsors as being “hard to get and easy to lose” and maintaining it during the review of the MAA requires “flawless procedure management” by the

Key Takeaways

  • The reason for the sharp drop last year in the number of requests from drug companies seeking an accelerated assessment of their planned EU marketing applications is not clear.

  • The main reasons for accelerated assessment requests being rejected in 2021 and 2022 were either that the unmet medical need the medicine was expected to address was not adequately justified, or that the data provided did not justify a major public health interest

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