In order to promote the technical standards of drug registration in line with international standards, upon study, NMPA decided to apply the ICH Guidelines M9 Biopharmaceutics Classification System-based Biowaivers and Q&A document thereof and Q5D Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products. On April 28, 2021, relevant matters were announced as follows:

I. Applicants are required to carry out the study in accordance with the ICH Guidelines as early as possible based on current technical requirements. For relevant studies that start 6 months after the issuance date of this Announcement (based on the time point of the trial record), the above ICH Guidelines shall apply.

II. The relevant technical guidelines may be accessed on the website of the Center for Drug Evaluation of NMPA. The Center for Drug Evaluation of NMPA shall be responsible for relevant technical guidance during the implementation of this Announcement.