On Mar. 24, 2023, China National Medical Products Administration (NMPA) released the Procedures for Adjusting Reference Listed Drugs (RLDs) of Chemical Generic Drugs (Trial) (hereafter referred to the RLD Adjustment Procedures) with immediate effect. RLDs are reference drugs to which generic drugs should be equivalent in safety and efficacy.
As the pharmaceutical technology develops, China NMPA finds that some listed RLDs no longer meet the Chinese Pharmacopoeia standards or the current technological requirements. That’s why NMPA formulates and implements the RLD Adjustment Procedures.
1. Conditions for Adjusting the RLD Catalog
Drugs in the RLD Catalog fall into the scope of adjustment if they are in any of the following three conditions:
1.1 The drug has been withdrawn from the market due to safety or efficacy reasons.
1.2 The drug is not encouraged to be copied because it, even though after technological improvement, still cannot meet the current version of Chinese Pharmacopoeia or the technological requirements of drug review.
1.3 Other conditions: after being evaluated, the drug is deemed not fulfilling the RLD criteria.
2. Proposal for Adjusting the RLD Catalog
Drug manufacturers, research companies, industrial associations, and the Center for Drug Evaluation (CDE) under NMPA can propose adjustments of the RLD Catalog according to the abovementioned conditions.
Companies and industrial associations can submit adjustment applications with sufficient evidence materials through the “Application for Questioning RLD” Module at the RLD Selection Platform.
3. RLD Catalog Adjustment Procedures
3.1 CDE Preliminary Review
CDE conducts the preliminary review of RLD adjustment application, formulates the preliminary comments, and sends them to the expert committee.
3.2 Expert Discussion
Experts discuss about the adjustment application. The discussion conclusion will be approval or disapprova according to the majority rule.
3.3 Publicity for Public Comments
After receiving the adjustment application, CDE will publicize the expert’s discussion conclusion within 60 workdays. The publicity period is 10 workdays.
3.4 Response to Objection
After the publicity period ends, CDE will respond to the objection as either of the following items.
(1) CDE views that the objection does not provide new evidence and has been sufficiently studied with a clear conclusion. CDE will keep the original discussion conclusion without arranging another discussion, and send the response to the objector within 45 workdays.
(2) CDE views that the objection provides new evidence which needs further study, and will arrange another expert discussion. In principle, CDE should invite the interested parties relevant to the drug to the discussion. The discussion conclusion will be public within 60 workdays. In principle, no more than two expert discussions will be held on the same issue.
After the aforementioned procedures, CDE will send the drug(s) that need to be listed from the RLD Catalog to NMPA to finally announce the RLD Catalog adjustment.
Resource for You
- China Catalog of Reference Listed Drugs
- China Abbreviated New Drug Application (ANDA) for Generic Drugs
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