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Regulatory Focus™ > News Articles > China to Require Registration of all Clinical Trials, Bioequivalence Studies

China to Require Registration of all Clinical Trials, Bioequivalence Studies

Posted 19 September 2013 | By Ansis Helmanis,

China's Food and Drug Administration (CFDA) is requiring clinical trial sponsors to register all trials (Phases I, II, III, IV) and bioequivalence testing, according to World Health Organization (WHO) requirements posted online.

The 6 September 2013 bulletin mandates that the required information be posted within one month after pre-registration of the trial, followed by an update within one year.

The trial's approval will be revoked if the registration requirements are not complied with within three years. For approved drugs, the registration must be completed within three months of the date of the notice. 

The website will be managed by CFDA's Center for Drug Evaluation.

CFDA Clinical Trial Registration Requirements

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