The National Medical Products Administration (NMPA) in China has released the 79th batch of reference drugs for Generic Quality Consistency Evaluation (GQCE) work, marking a significant step in ensuring the quality and consistency of generic drugs in the country. This batch includes 64 new specifications and 34 modified specifications for generic drugs, with 4 and 3 of these being injectables, respectively.
The specifications with modifications encompass a range of drugs, including originator drugs that have not yet been imported into China, those already listed in the Chinese market, as well as reference preparations that are part of the orange books in Japan and the United States. The release of these reference drugs is aimed at guiding pharmaceutical companies in the development of generic drugs that meet the required quality standards, thereby promoting the availability of affordable and consistent medications for patients. – Flcube.com
