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EU looking at ‘possible regulatory bottlenecks’ for clinical trials


Commission official says delays to research related to “interplay” between two different laws

The European Commission is quietly consulting with the EU’s member states on “possible regulatory bottlenecks” for clinical trials involving diagnostics, amid pharmaceutical industry concern about the bloc’s rules causing delays.

The European Federation of Pharmaceutical Industries and Associations (Efpia) said last month that the In Vitro Diagnostic (IVD) Regulation, which sets rules on diagnostic tests using human blood or other samples, could lead to delay for hundreds of clinical trials.

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