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Germany Courts Clinical Trials With Regulator Reshuffle & New Federal Ethics Committee

 
• By Francesca Bruce

Plans to rejig two regulators’ roles and streamline the ethics committee system have drawn some criticism.

BfArM
New bill would see BfArM become responsible for approving most clinical studies and for coordinating filings for marketing authorizations • Source: Shutterstock

A new bill going through the legislative process in Germany aims to make the country a more attractive location for clinical research by streamlining the system governing ethics committees and reorganizing the competencies of Germany’s two regulators, BfArM and the Paul-Ehrlich-Institute (PEI).

The bill could reduce bureaucracy and bring more simplicity to the processes for authorizing clinical studies, said Adem Koyuncu, a Frankfurt-based partner at the law firm Covington & Burling. However, there is some concern that the regulator reorganization will lead to confusion and a “loss of energy,” he told the Pink Sheet

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