China’s NMPA to improve the transparency and efficiency of the registration dossier acceptance and review, NMPA CDE issued a revision of the guidelines of the registration dossier acceptance for chemical drug and biologics, which is now ready for public comment due by March 4th, 2022.


For order to timely update and disclose the acceptance standards, improve the quality of acceptance work, and better serve the applicants, and at the same time, in order to implement the requirements of the “implementation measures for the early resolution mechanism of drug patent disputes (trial)”, it is proposed to revise the guidelines for the acceptance and review of the registration of traditional chinese medicines, chemical drugs and biological products. The center has organized the drafting of the “guidelines for the acceptance and review of the registration of chinese medicines

The guidelines for the acceptance and review of the registration of chemical drugs , and the guidelines for the acceptance and review of the registration of biological products , are published on the website of the center to widely listen to the opinions and suggestions of all walks of life. welcome valuable comments and suggestions from all walks of life on the revised content, and please give timely feedback to our center.

Main Changes: In the Registration Dossier for Chemical and Biological Drugs


1. Reiterate the information consistency of API/excipient/packaging material registration numbers with those disclosed on CDE’s DMF registry platform.
2. For local-manufactured drug product using APIs imported out of China, if API registration is not completed on CDE’s DMF registry platform for specific reasons, notarized certification documents and Chinese translations of the drug substance overseas marketing and manufacturing site in compliance with GMP shall be submitted.
 3. The validation of the commercial scale manufacturing process should be completed when applying for drug registration under “other application dossiers”. Process validation protocol and process validation report shall be submitted in the marketing authorization dossier. 
4. When submitting an application for drug marketing authorization for a chemical generics, the applicant shall make a statement on each relevant drug patent of the generic drug in accordance with the proprietary information that is already disclosed on the platform for the registration platform of patent information for drugs marketed in China.
5. Applicant should select the reference product disclosed in the final list of Chemical Generic Drug Reference Products from NMPA website, and fill in the corresponding information of the reference product used in the study in the “Reference Product Information (applicable for generic drug)” .
6. Certificate of Origin of Reference Product generally includes batch approval information on the official website, photographs of the physical and packaging labels (including primary and secondary packaging) of the purchased reference product, purchase invoices, package inserts, import drug approvals and copies of import drug clearance forms (to be provided when using reference products
7. The source (marketing country or region) of the reference product, the generic name, English name, trade name, strength, dosage form, license holder, etc. of the reference product shall be described. “



 For the link, click here (Only available in Chinese).

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