July 2020: China Regulatory Update

In accordance with the relevant requirements of the 2019 version of the “Drug Administration Law” and the 2020 version of the “Drug Registration Management Measures”, combined with common problems in the use of the original registration platform, the system upgrade and functional transformation were initiated in early 2020. The new platform merges the “drug clinical trial registration and information disclosure platform” with the “chemical generic drug bioequivalence and clinical trial filing information platform”.

At the same time, in order to ensure the authenticity of the applicant’s identity and the authenticity and validity of the registration information, the new platform uses the real-name ukey account in the “Applicant Window” section of the Drug Evaluation Center website to log in.

On September 6, 2013, the China Food and Drug Administration (CFDA) announced that it has established a Registration and Information Disclosure Platform for Drug Clinical Studies (“Platform”) via the website of CFDA’s Center for Drug Evaluation (website: www.cde.org.cn).  CFDA requires all clinical studies being conducted in China and approved by CFDA, including Phase I, II, III & IV studies, bioequivalence and PK studies, to be registered on the Platform.


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