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Top EU Regulator Attacks Complexity & Duplication In European System

Long Approval Times In The Spotlight At DIA Europe

 
• By Ian Schofield

Industry and agency speakers at the DIA Europe 2022 conference voiced a litany of complaints about the EU’s drug regulatory framework, saying it has failed to keep up with developments in science and that too much assessment work is being duplicated.

3D illustration of 3 flows of spheres converging in a single row over black background
The EU regulatory system could do with some streamlining • Source: Alamy

The European medicines regulatory system has become too complex, there are too many decision-makers with overlapping responsibilities, and its design is “not quite fit” for the 21st century.

On top of that, the system suffers from resource issues at EU member state agencies that mean the European Medicines Agency’s human drugs committee, the CHMP, cannot do its job...

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