To promote the alignment of drug registration technical standards with international standards, after research, the National Medical Products Administration (NMPA) has decided to adopt the ICH Guideline M13A: Bioequivalence for Oral Solid Immediate-Release Products (hereinafter referred to as the M13A Guideline). The relevant matters are hereby announced as follows:
1. From the date of this announcement, all varieties submitted for registration shall follow the M13A Guideline (including Q&A documents). For varieties that have already conducted bioequivalence studies according to previous clinical trial protocols and statistical analysis plans, and are submitted within 12 months from the date of this announcement, the original technical standards may still be followed for research and review.
2. The Chinese and English versions of the M13A Guideline are available on the NMPA Centre for Drug Evaluation website. The NMPA Centre for Drug Evaluation is responsible for providing technical guidance during the implementation of this announcement.
3. Other previously issued guidelines involving oral solid immediate-release products, if inconsistent with the technical standards of the M13A Guideline, shall follow the M13A Guideline.
National Medical Products Administration
May 20, 2026
(Reprinted from: Official WeChat account of the Centre for Drug Evaluation, National Medical Products Administration)