The National Medical Products Administration (NMPA) has released the 60th batch of reference drugs for generic quality consistency evaluation (GQCE) work. This batch includes 75 specifications, with 18 specifications undergoing modifications due to increases in marketing authorization holders (MAH) or changes to unlimited trade names.
Details of the Release
The release of the 60th batch of reference drugs is part of NMPA’s ongoing efforts to ensure the quality and consistency of generic drugs in the Chinese market. The inclusion of 75 specifications highlights the agency’s commitment to expanding the scope of drugs subject to GQCE. The modifications to 18 specifications reflect changes in marketing authorization holders or updates to trade names, ensuring that the reference drugs list remains current and accurate.
Implications for the Generic Drug Market
This update is significant for pharmaceutical companies aiming to produce generic versions of these drugs, as it provides clear guidelines and reference standards for quality consistency evaluation. The NMPA’s GQCE program is designed to enhance the quality and efficacy of generic drugs, ultimately benefiting patients by ensuring access to high-quality, affordable medications.-Fineline Info & Tech
