NMPA Announcement on Adopting ICH Guidelines M10 Q&As and FAQs

To align the technical standards for drug registration with international standards, the NMPA upon deliberation decided to adopt the ICH(International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) Guidelines M10: Bioanalytical Method Validation And Study Sample Analysis (hereinafter referred to as M10) Q&As documents and FAQs documents. The relevant items are hereby announced as follows:

1. The relevant studies starting from July 29, 2023 (based on the original record time of biological sample analysis) are applicable to M10 Q&As documents and FAQs documents.

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

The National Medical Products Administration

June 29, 2023