To align the technical standards for drug registration with international standards, the NMPA has decided to adopt the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. The relevant items are hereby announced as follows:

1. The guidelines of Q12 provide a new approach and regulatory tool for post-approval changes for drugs. Applicants can conduct change management in accordance with the relevant regulations, provisions and guiding principles of change management in China, or use the new approach provided by Q12 when submitting marketing applications and/or supplementary applications. Before implementing Q12, applicants should fully evaluate whether they have the research and development foundation and implementation conditions applicable to the guidelines.

2. Starting from August 25, 2023, there will be a transition period of 24 months for the implementation of Q12. For drug registration applications during the transition period, if the applicant adopts Q12 for change management, please communicate and exchange with the Center for Drug Evaluation (CDE) of NMPA before submitting the drug registration application according to the relevant requirements of the management measures for communication and exchange of drug research and development and technical review (the NMPA CDE Notice No. 48 of 2020). Before the end of the 24 month transition period, it will be determined whether to extend the transition period based on the practical conditions during the transition period.

3. The Chinese and English versions of Q12 guidelines can be found at the CDE website. The CDE of NMPA is responsible for providing relevant technical guidance during the implementation of this Announcement.

National Medical Products Administration

August 25, 2023