The National Medical Products Administration (NMPA) has released the 72nd batch of reference drugs for generic quality consistency evaluation (GQCE) work. This batch includes 22 new specifications, of which three are injectables, and 27 specifications with modifications, including one injectable. These reference drugs are crucial for ensuring the quality and consistency of generic drugs in the market.
Details of New and Modified Specifications
The modifications in the 72nd batch encompass changes in marketing authorization holder (MAH) increases and updates to both Chinese and English generic names. These updates are essential for maintaining accurate records and facilitating the evaluation process.
Implications for Generic Drug Manufacturers
The release of the 72nd batch of reference drugs by the NMPA is a significant step for generic drug manufacturers. It provides a benchmark for quality assessment and helps ensure that generic drugs meet the required standards. This process is vital for patient safety and the overall reliability of the pharmaceutical supply chain.-Fineline Info & Tech
