The National Medical Products Administration (NMPA) has released the 58th batch of reference drugs for generic quality consistency evaluation (GQCE) work. This batch includes a total of 41 new specifications, among which 13 are injectables. The release aims to further standardize the quality of generic drugs in the Chinese market, ensuring they meet the same high standards as their branded counterparts.
Modifications and Corrections
In this batch, two specifications underwent modifications due to the correction of marketing authorization holder (MAH) errors and other reasons. These adjustments highlight the NMPA’s commitment to accuracy and compliance in the regulatory process, ensuring that all reference drugs listed for GQCE are correctly identified and categorized.
Impact on the Generic Drug Market
The release of these reference drugs is a crucial step in the ongoing efforts to enhance the quality and consistency of generic drugs in China. By providing clear benchmarks for quality evaluation, the NMPA aims to boost confidence in generic medications and support the broader use of cost-effective treatment options in the healthcare system.-Fineline Info & Tech
