The National Medical Products Administration (NMPA) has released the 57th batch of reference drugs for generic quality consistency evaluation (GQCE) work, including 19 injectables among a total of 86 new specifications. Nine specifications were modified due to increases in marketing authorization holders (MAHs).
Batch Details
The latest batch aims to expand the list of reference drugs for GQCE, supporting the development of high-quality generic drugs in China. The inclusion of injectables and modifications to existing specifications reflects ongoing efforts to improve drug quality and availability.
Implications
The updates will guide generic drug manufacturers in conducting consistency evaluations, ensuring that generics meet the required standards for efficacy and safety. The modifications to specifications due to MAH increases highlight the dynamic nature of the drug approval process.-Fineline Info & Tech
