The National Medical Products Administration (NMPA) has released the 69th batch of reference drugs for generic quality consistency evaluation (GQCE) work, further enhancing the standards for generic drug quality in the market. This batch includes 10 new specifications and 34 specifications with modifications, reflecting the NMPA’s ongoing commitment to ensuring the safety and efficacy of generic medications.
Details of the Modifications and New Specifications
The modifications in this batch encompass a range of updates that are crucial for the consistency and quality of generic drugs. These include changes in marketing authorization holder (MAH) increases and alterations in specifications, trade names, and English generic names. These updates are essential to maintain the accuracy and relevance of the reference drugs used for quality assessments.
Importance of Generic Quality Consistency Evaluation
The GQCE work is a critical component of the pharmaceutical industry’s efforts to ensure that generic drugs meet the same high standards of quality and efficacy as their branded counterparts. By regularly releasing batches of reference drugs, the NMPA is providing a benchmark for manufacturers to compare their products against, thereby promoting consistency and reliability in the generic drug market.-Fineline Info & Tech
