The Center for Drug Evaluation (CDE) in China has announced the selection of the 89th batch of reference preparations for the purpose of generic quality and consistency evaluation (GQCE). This process is crucial for ensuring that generic drugs meet the same high standards of quality and efficacy as their branded counterparts.
Expansion of Reference Preparations and Specifications
The draft opinion for this batch includes the addition of 35 new drugs and 40 specifications to the list of reference preparations. These additions are part of the ongoing efforts to expand the range of drugs available for GQCE, thereby facilitating the development and approval of high-quality generic medications.
Drugs That Failed Review
Concurrently, the CDE has reported that a total of 18 drugs did not pass the review process. The reasons for their failure to be included as reference preparations include ineligibility to act as a reference, as well as literature that could not sufficiently support their clinical value. These drugs will not be used as benchmarks for the GQCE process.
Implications for Generic Drug Development
The selection of reference preparations is a critical step in the generic drug development process. It ensures that manufacturers have clear standards to meet when developing generic alternatives. The CDE’s rigorous review process helps maintain the quality and consistency of medications available to patients, promoting public health and safety.-Fineline Info & Tech
