To align the technical standards for drug registration with international standards, the NMPA has decided upon deliberation to adopt the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines S12: Nonclinical Biodistribution Considerations for Gene Therapy Products(hereinafter referred to as S12). The relevant items are hereby announced as follows:

Nonclinical studies starting from the issuance of this Announcement shall be applied to S12. The determination of the starting date of nonclinical studies shall be in accordance with the relevant provisions of the Good Laboratory Practice for drugs.

The guidelines can be found at the website of the Center for Drug Evaluation(CDE) of the NMPA. The CDE of NMPA is responsible for providing relevant technical guidance during the implementation of this Announcement.

National Medical Products Administration

September 4, 2023