The National Medical Products Administration (NMPA) has released a document outlining procedures for the adjustment of “Chemical Drug Generic Reference Preparation,” which are set to take effect immediately. This move aims to streamline and update the reference preparations for generic drugs in China, ensuring alignment with current pharmacopoeia standards and review technical requirements.
Background on Generic Reference Preparations
Since 2016, the NMPA has released 66 batches of preparations for generic reference, covering 2,408 drug varieties and 6,174 specifications. However, some reference preparations are now deemed out of line with the current Chinese pharmacopoeia or review technical requirements, or have been delisted due to safety or efficacy issues. This has necessitated the adoption of a dynamic management procedure to remove ineligible products from the lists.
Adjustment Scenarios Detailed by NMPA
Scenario 1: Reference preparations included in the Generic Reference Preparation List will be removed if they are delisted from the market due to safety or efficacy issues. If the reference preparation is sourced from abroad and the country of origin has withdrawn the variety due to safety or effectiveness reasons, the corresponding variety in the reference preparation list should be removed after a full evaluation if the risk outweighs the benefit. If a drug is withdrawn from the market in the country of origin for non-safety or effectiveness reasons, the reference formulation in the list will not be adjusted.
Scenario 2: Some drugs currently on the market at home and abroad still fail to meet the current Chinese Pharmacopoeia or technical review requirements even after technical improvement.
Scenario 3: Other situations as outlined in the document.
Impact on Generic Drug Applications and Listings
For drugs under Scenario 1, any pending applications for generic drug marketing and generic drug quality and efficacy consistency evaluation will not be approved. Varieties belonging to Scenarios 2 and 3 will not be included in the Catalogue of Listed Drugs after the review of the generic drug listing application. Applications for consistency evaluation of the quality and efficacy of generic drugs under review will be evaluated in line with the supplementary application for post-marketing changes, and the relevant policies for consistency evaluation will not apply after approval. Generic drugs that have been approved for marketing or have passed the quality and efficacy consistency evaluation will be removed from the Catalogue of Listed Drugs simultaneously.-Fineline Info & Tech
