The National Medical Products Administration (NMPA) has released the 78th batch of reference drugs for generic quality consistency evaluation (GQCE) work, marking a significant step in ensuring the quality and consistency of generic drugs. This batch includes 28 new specifications and 28 specifications with modifications, with 7 of these being injectables and 4 involving modifications related to the addition of marketing authorization holders (MAH).
The inclusion of these new and modified specifications underscores the NMPA’s commitment to enhancing the standards of generic drugs, thereby promoting patient access to affordable and high-quality medications. The modifications, particularly those involving MAHs, reflect the dynamic nature of the pharmaceutical industry and the need for continuous updates to regulatory frameworks to accommodate market changes and advancements in drug development.- Flcube.com