China Drug Registration and Approval - Overview
National Medical Products Administration (NMPA) (formerly known as China Food and Drug Administration [CFDA]), is the main Regulatory authority responsible for pharmaceutical product/ drug registration in China. The Center for Drug Evaluation (CDE) of NMPA is responsible for evaluating drug clinical trial applications, drug marketing authorization applications, supplementary applications, and NMPA registration renewal applications of drugs manufactured overseas.
Medicinal Product Classification in China
The NMPA regulations classify drugs into the following categories.
- Chemical Drugs (small molecules).
- Total nine (09) classes.
- Two (02) classes related to the NCE (marketed outside China, not marketed globally).
- Biological Products (Thirteen (13) classes).
- Traditional Chinese Medicine (Ten (10) classes).
Medicinal Product Registration in China
The pathway for the medicines/drug registration in China depends upon the categorization of the drug product as per the NMPA regulation. The classification decides the Regulatory approval process in China.
A foreign manufacturer/applicant must have a legally appointed local agent responsible for the pharmaceutical Regulatory affairs in China to carry out the registration process with the National Medical Products Administration (NMPA). The applicant must submit the Marketing Authorization Holder (MAH) application to the National Medical Products Administration (NMPA).
For imported drugs, the marketing approval, as part of the China drug approval process, includes the drug approval license. The applicant needs to submit the M1 administrative documents, drug information, and the M2-5 CTD dossier. The M1 should include the cover letter, application form, labeling, clinical trial information (if needed), specification, production-process information, and approval-supporting documents (if needed), such as the DMF certification, GMP certification, COPP, LOA/POA, etc.
The CDE carries out a technical evaluation of the dossier content after a comprehensive review of the application dossier, verification, and audit results. Once the review is complete and the NMPA has approved the product, the CDE authorizes a Drug Approval License.
Important Validities
The Drug Approval License is valid for five (05) years, and according to the NMPA regulations, the MAH must apply for the renewal certificate six (06) months prior to the expiry of the validity period.
China Drug Registration and Approval - Freyr Expertise
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