 Home > Active Ingredient News > Drugs Articles > The State Food and Drug Administration on the application of "M9: Bioequivalence Exemption Based on Biopharmaceutical Classification System" and Q&A documents and "Q5D: Source and Identification of Cellular Matrices Used in the Production of Biotechnology Products and Biological Products" International Human Drugs Announcement of Guiding Principles of Registration Technology Coordination Committee (No. 61 of 2021)

The State Food and Drug Administration on the application of "M9: Bioequivalence Exemption Based on Biopharmaceutical Classification System" and Q&A documents and "Q5D: Source and Identification of Cellular Matrices Used in the Production of Biotechnology Products and Biological Products" International Human Drugs Announcement of Guiding Principles of Registration Technology Coordination Committee (No. 61 of 2021)

 Last Update: 2021-05-22
 Source: Internet
 Author: User

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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.

National Food and Drug Administration

April 28, 2021

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