EFPIA On How EU Can Become A ‘World Leader’ In Life Sciences

Report Draws On 60 Case Studies Of Regulatory Hurdles

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 Medicines Agency's building in Amsterdam
The EMA is at the center of the EU regulatory network • Source: Alamy

The European pharmaceutical industry federation EFPIA has published a report outlining a set of “clear and actionable recommendations” for improving the EU pharmaceutical legislation to “enable rapid patient access to medicines without compromising safety.”

The report, called Evidence MIX: Evaluating the EU Regulatory System, is part of EFPIA’s response to the European Commission’s Pharmaceutical Strategy, in particular a proposal for a wholesale revision of the EU medicines legislation, which is expected at the end of this year

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