China’s Center for Drug Evaluation (CDE) has released the 91st batch of reference preparations for generic drug quality and consistency evaluation (GQCE). This update is part of the ongoing efforts to standardize and improve the quality of generic drugs in the country.
New Additions and Rejections
The latest batch includes 59 new drugs and 27 specifications. However, 29 drugs failed to pass the review. Reasons for rejection include ineligibility to act as a reference, lack of clinical advantage, and inability to prove the adequacy of clinical data.
Implications for the Generic Drug Market
The CDE’s continuous updates to the reference preparation list reflect China’s commitment to enhancing the quality and efficacy of generic drugs. By maintaining rigorous standards, the CDE aims to ensure that generic medications meet the necessary criteria for safety and effectiveness, ultimately benefiting patients through more reliable treatment options.-Fineline Info & Tech
Leave a Reply