To promote the technical standards of drug registration in line with international standards. After research, the National Medical Products Administration decided to apply "M9: Bioequivalence Exemption Based on Biopharmaceutical Classification System" and Q&A documents and "Q5D: Source and Identification of Cell Matrix Used in the Production of Biotechnology Products and Biological Products" Guidelines for the International Technical Coordination Committee on Drug Registration for Human Use (ICH). The relevant matters are hereby announced as follows:
        1. The applicant shall conduct research in accordance with the ICH guidelines as soon as possible on the basis of the current technical requirements. Relevant research (subject to the time point of the test record) starting 6 months after the date of this announcement shall be subject to the above-mentioned ICH guidelines.
        2. Relevant technical guidelines can be found on the website of the Center for Drug Evaluation of the State Drug Administration. The Drug Evaluation Center of the National Medical Products Administration is responsible for the relevant technical guidance during the implementation of this announcement.
        Special announcement.

National Food and Drug Administration