FDAnews Drug Daily Bulletin

China Proposes Changes for Clinical Trials Practices and Regulations

Dec. 30, 2016

China’s Food and Drug Administration recently proposed revisions to its good clinical practices guidelines, standardizing the conduct of drug studies. According to the global law firm Ropes & Gray, the revisions are similar to those proposed by the International Conference on Harmonization guidelines.

The proposed changes, which are taking comments through January 2017, include regulating the handling of biological specimens, extending insurance coverage to institutions, allowing individuals to serve as sponsors or contract research organizations, and requirements to notify investigators and participants of which treatment they received following the unblinding of a randomized study.

The revisions would also mandate that clinical trial agreements must be structured as a three-party agreement between the sponsor, investigator and institution. For multi-center studies, sponsors must sign the agreement with all participating investigators and institutions.

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