The National Medical Products Administration (NMPA) has released the 55th batch of reference drugs for generic quality consistency evaluation (GQCE) work. This batch includes 16 injectables among a total of 78 new specifications. Additionally, 21 specifications saw modifications, including four injectables.
Batch Details
The latest batch aims to provide updated reference standards for generic drug manufacturers to ensure quality consistency. The inclusion of 16 injectable formulations highlights the focus on expanding reference criteria for this category of drugs.
Modifications
Among the 21 modified specifications, four injectables were updated. These changes reflect ongoing efforts to refine and improve the evaluation criteria for generic drugs, ensuring they meet the required safety and efficacy standards.-Fineline Info & Tech
