1. Pink Sheet

Pharma Industry Lists Multiple Failings Of EU Regulatory System

EFPIA Wants Less Complexity, More Flexibility In Drug Evaluations

 
• By Ian Schofield

The European Commission’s plans for overhauling the EU medicines legislation have elicited a number of proposals from the pharmaceutical industry to improve the regulatory framework, including streamlining the committee system, improving the use of expedited evaluation pathways, and expanding the European Medicines Agency’s role in assessing drug/device combination products.

Hand moving pawn on a conceptual maze.
The EU regulatory system is in need of streamlining • Source: Alamy

The EU’s regulatory framework is “complex, slow and administratively burdensome,” and the European Medicines Agency’s committee structure and network operating model are “reaching their limits” in terms of speedy, high-quality assessments.

More expertise is needed to assess highly innovative medicines, but this may not be available in the EU network and...

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