Content Analysis and Basic Evaluation of the Third Revised Version of China's “Provisions for Drug Registration”

Abstract

Abstract

China's Food and Drug Administration (CFDA) published three revised versions of “Provisions for Drug Registration” from 2014 to 2017. The Third Revised Version of “Provisions for Drug Registration” was promulgated recently and approaches maturity. On the one hand, the Third Revised Version of “Provisions for Drug Registration” enhances the authority of CFDA; sets requirements for types of drug registrations, clinical drug trial authenticity, drug registration application review, and drug registration standards; and strengthens both drug intellectual property protection and drug experimental data protection, resulting in a reduction in the pass rate for drug registration applications. On the other hand, The Third Revised Version of “Provisions for Drug Registration” relaxes restrictions on drug registration applicant qualifications and on the use of overseas experimental data, introduces priority review and approval regulations, allows drug advance marketing authorizations (with conditions), and approves drug extended therapy. Under it, in the future, more attention will be paid to new drugs and drug quality in China's drug registration application.