The National Medical Products Administration (NMPA) has released the 59th batch of reference drugs for generic quality consistency evaluation (GQCE) work. This batch includes a total of 67 new specifications, among which 15 are injectables. The update aims to further standardize and improve the quality of generic drugs in the Chinese market.
Details of the Release
In this batch, 13 specifications underwent modifications due to various reasons, including the correcting of specifications and generic names, as well as the addition of Marketing Authorization Holders (MAH). These changes reflect the NMPA’s ongoing efforts to ensure the accuracy and reliability of reference drugs used in the GQCE process.
Impact on Generic Drug Market
The release of the 59th batch of reference drugs is part of the NMPA’s broader strategy to enhance the quality and consistency of generic drugs. By providing clear reference standards, the administration aims to support the development and approval of high-quality generic medications, ultimately benefiting patients through increased access to affordable and effective treatments.-Fineline Info & Tech
