China Releases Working Procedures for Breakthrough Therapy Drugs, Conditional Approval and Priority Review

In order to support the implementation of the new Regulations of Drug Registrations, The National Medical Products Administration(NMPA) of China has published interim regulatory decisions pertaining to drug conditional and priority review which are namely, the “Working Procedure for the Review and Approval of Breakthrough Therapy Designated Drugs”, “Working Procedure for Drug Conditional Marketing Authorization Application, Review and Approval” and “Working Procedure for Drug Priority  Marketing Authorization Review and Approval”.

The Working Procedure for the Review and Approval of Breakthrough Therapy Designated Drugs aims to stimulate and encourage research and development of innovative drugs with apparent clinical benefits.
In the event the drug exhibits benefits of treating life-threatening or serious conditions with initial clinical proof showing benefits as compared to other available therapies, the drug sponsors may apply for breakthrough therapy designation during Phase 1 & Phase 2 clinical trial periods. The content of the guideline covers administrative steps and requirements and scope of requirements and application for designation. The annexure contains information on the key issues during the initial communication between the evaluation authority and applicant and required application forms.

The second annexure, namely the Working Procedure for Drug Conditional Marketing Authorization Application, Review and Approval (Interim), increase the marketing authorization approval rate for drugs that possess high clinical value or are in critical clinical need.  This applies to drugs that are meant to treat life-threatening or seriously debilitating diseases when no alternative treatment is available or are vaccines in critical need during any public health emergency or in the requirement for public health.

The final annexure which is the Working Procedure for Drug Prioritized Marketing Authorization Review and Approval (Interim) is aimed to stimulate research and development of innovative drugs of urgent clinical needs or which has substantial clinical value. The function of drugs includes of which possess apparent clinical benefits, innovative pediatric drugs, drugs for rare diseases, drugs that are critically needed for disease prevention and control. The sponsors may apply for prioritized approval and review. The annexure contains templates for the relevant application forms as well the guideline provides administrative procedures and requirements as well as criteria and scope for priority review.

NMPA has made an announcement on launching an online application portal on its website that enables the application of prioritized marketing authorization and breakthrough therapy designated drugs.

The decisions could be accessed here:-

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