The National Medical Products Administration (NMPA) has released the 70th batch of reference drugs for the purpose of generic quality consistency evaluation (GQCE) work. This release is a part of ongoing efforts to ensure the quality and consistency of generic drugs in the market.
Changes in the Official Version Compared to Draft Proposal
The official version of the 70th batch differs from the draft proposal, with the removal of remimazolam (25mg and 50mg) and acetylcysteine from the list. This leaves 16 newly added specifications that have been retained for evaluation. Additionally, 10 specifications have undergone modifications, which include changes to the generic name and alterations in the marketing authorization holder (MAH).
Implications for Generic Drug Manufacturers
These updates to the reference drugs list are critical for generic drug manufacturers as they provide a benchmark for quality and consistency. The changes reflect the dynamic nature of the pharmaceutical industry and the need for continuous evaluation and adjustment to maintain standards. Manufacturers must align their products with these reference specifications to meet regulatory requirements and ensure patient safety.-Fineline Info & Tech
