Pharma Industry Lists Multiple Failings Of EU Regulatory System
EFPIA Wants Less Complexity, More Flexibility In Drug Evaluations
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.
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More agile regulatory processes, a much shorter period for the European Commission to make new drug approval decisions, and a firm legal basis for the European Medicines Agency in assessing combination products. These are among proposals put forward by Europe’s R&D-based pharmaceutical industry amid moves to revise the EU medicines legislation.
The European Commission has launched the process for reshaping and addressing the long-standing weakness in the EU’s pharmaceutical legislation. It has listed in a roadmap the issues it wants to address as it considers policy options for reforms.
In an exclusive interview with the Pink Sheet, the European Medicines Agency’s Tony Humphreys explains the thinking behind the agency’s regulatory science strategy, why the PRIME scheme is to get a boost – and why the need to tackle health threats ranked so low in a stakeholder consultation.