The Center for Drug Evaluation (CDE) has released a new set of Guidelines for “the Acceptance and Review of Quality and Efficacy Consistency Evaluation of Generic Drugs.” Although described as a draft proposal with a one-month feedback period from the date of issuance, the guidelines are set to take immediate effect, impacting the generic drug evaluation process in China.
Clarification on Generic Quality and Consistency Evaluation (GQCE) Process
The Guidelines provide clarity on the generic quality and consistency evaluation (GQCE) process for chemical drugs in China. They outline application items, reference formulations, stability, clinical data, and other review points critical to the GQCE process. Applicants are required to conduct an evaluation of a generic drug against reference preparations based on the National Medical Products Administration’s (NMPA) Generic Reference Preparation List.
Application Process and Timelines
Applications for GQCE trials can be submitted alongside other change requests, with the CDE mandated to acknowledge receipt of materials and conduct a formal review within 5 days. For products that fail to meet the requirements, the CDE will either request corrections or issue a rejection, explaining the reasons. Products that meet the requirements can proceed to the subsequent technical review.
Significant Changes to Previous Rules
A significant departure from previous rules is the stipulation that three years after the first generic version of a particular molecule passes the GQCE evaluation, no other GQCE filings for the same variety will be accepted. Products deemed clinically necessary and in short supply may apply for an extension of this period with the local provincial drug regulatory department. Drugs manufactured overseas or pharmaceutical products from Hong Kong, Macao, and Taiwan can apply to the national drug regulatory authority for an extension of the cut-off period.-Fineline Info & Tech
