The National Medical Products Administration (NMPA) has released the 67th batch of reference drugs for generic quality consistency evaluation (GQCE) work, further expanding the list of drugs under evaluation. This batch includes 50 new specifications, with 11 injectables and 29 specifications undergoing modifications.
Details of the 67th Batch of Reference Drugs
The modifications in this batch encompass changes and increases in marketing authorization holder (MAH) details. These updates are crucial for maintaining the accuracy and relevance of the reference drugs list, ensuring that generic drugs meet the required quality standards.
Implications for Generic Drug Manufacturers
The release of the 67th batch of reference drugs by the NMPA is a significant step for generic drug manufacturers. It provides clarity on the expectations for quality and consistency, facilitating the development and approval process for generic drugs. This initiative is part of the ongoing efforts to improve access to affordable, high-quality medicines for patients in China.-Fineline Info & Tech
