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Roche Wants EU Pharma Legislative Revision To ‘Dare Something New’

 
• By Ian Schofield

New, more flexible regulatory approaches will be needed to deal with the integrated therapies coming through company pipelines, and the European Medicines Agency should play a “key orchestrating role” in smoothing the way, says Sabine Atzor, Roche’s head of EU regulatory policies.

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The EU medicines legislative framework is to undergo a radical shake-up • Source: Shutterstock

The European Commission’s Pharmaceutical Strategy and the forthcoming revision of the medicines legislation represent a “unique” opportunity to remedy the deficiencies of the EU drug regulatory system and to implement a much lighter and more agile approach to medical product oversight at the European Medicines Agency, according to Sabine Atzor of Roche.

In future, more integrated products will be submitted to the EMA for assessment, including combinations of pharmaceuticals, diagnostics and digital tools, but the EU regulatory network as currently configured is too complex to

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