EUCOPE Wants Simpler Manufacturing Rules And Framework For Combined Trials Under EU Biotech Act

EU authorities must “take advantage” of the upcoming Biotech Act to reassess the bloc’s policies and “offset existing challenges” for small and midsized enterprises, trade association EUCOPE has said.

A proposal for the Biotech Act is expected next year following an upcoming public consultation (Shutterstock)

Key Takeaways

EUCOPE has urged the European Commission to simplify data requirements on product manufacturing under the upcoming Biotech Act to support small and mid-sized biotech companies.

The European Commission should simplify manufacturing data requirements and establish a coordinated framework for drug-device combination trials under its upcoming...

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