CFDA issues extensive DRR draft amendments

The China FDA invites comments on their latest revision of their Drug Registration Regulation

The China Food and Drug Administration (CFDA) this week issued a draft of revisions to the Drug Registration Regulations (DRR), seeking public feedback until August 26, 2016. Notably, preliminary analysis indicates that the revisions are extensive reducing the length of the current 2007 edition of the DRR to eight sections and 147 clauses from 15 sections and 177 clauses previously. The DRR is the key legal document underpinning drug registrations in China. An upgrade is necessitated by the changes in the definition of “novel” and “generic” drugs; the shift to take into account the product’s level of innovation and clinical advantage in selecting registration category; and the requirement for quality and efficacy evaluations between generic and originator drugs.

The text of the new regulation is available in Chinese language only on the CFDA homepage.

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