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NMPA Announcement on Adopting ICH Guidelines M7(R2)

To align the technical standards for drug registration with international standards, the NMPA has decided to adopt the ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use) Guidelines M7(R2): Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk (hereinafter referred to as M7(R2)). The relevant items are hereby announced as follows:

1. Applicants are required to carry out the study in accordance with the M7(R2), M7(R2) Q&As, Addendum to M7(R2) Guidelines based on current technical requirements. For relevant studies that start from July 3, 2024 (based on the time point of the study record), the above ICH Guidelines shall apply.

2. The relevant technical guidelines may be accessed on the website of the Center for Drug Evaluation of NMPA. CDE of NMPA shall carry out technical guidance in relation to the implementation of this Announcement.