On Sept. 25, 2023, China Center for Drug Evaluation (CDE) released the draft of the Guidance for the Acceptance Review of Quality and Therapeutic Equivalence Evaluation Applications for Generic Drugs.
Equivalence Approval Must be Achieved within the Required Timeframe, or No Opportunity Will be Granted
One of the most noteworthy regulations outlined in the draft is that the CDE will no longer accept equivalence evaluation applications for generic drugs of the same type if they are submitted three years or more after the first generic drug passes the equivalence evaluation.
In this context, "same type" refers to drugs that contain identical active pharmaceutical ingredients (APIs).
Equivalence evaluation is aimed at generic drugs that were granted marketing authorization based on standards that were established long ago and are currently considered lower than those of the reference listed drugs (RLDs) recognized by the National Medical Products Administration (NMPA). Abbreviated new drug applications (ANDAs) that are approved on par with RLDs automatically pass the equivalence evaluation.
Exemptions
The draft also includes provisions for exemptions. Under certain conditions and corresponding filing requirements, the three-year period for equivalence evaluation can be extended. This means that generic drug companies have the opportunity to apply for equivalence evaluation even if more than three years have passed since the first generic drug successfully completed the evaluation.
Table: Conditions and requirements for extending the 3-year period for equivalence evaluation following approval of the first generic drug
Condition for drug | Requirement for applicant |
Based on the evaluation conducted by the applicant company, the drug has been determined to be clinically necessary and experiencing a shortage in the market. | The applicant is required to submit a request for an extension to the local provincial-level medical products administration. |
The drug is manufactured outside of China or in China's Hong Kong Special Administrative Region (SAR) / Macao SAR. | The applicant is required to file a request for an extension to CDE |
The competent authority mentioned in the aforementioned table will make a decision regarding the approval of the requested extension after studying the proposed drug.
In 2016, China started inplementing equivalence evaluations with the aim of aligning the quality and efficacy of previously approved generics with that of RLDs. However, not all generics with marketing authorization have successfully undergone equivalence evaluations.
If generics fail to meet the current drug standards and do not pass the required equivalence evaluation within the designated timeframe, they will be ineligible for the renewal of their marketing authorization license.
Consequently, for generics companies, it is crucial to successfully complete the equivalence evaluation in order to remain competitive in the market, particularly when their competitors manufacturing the same type of drugs achieve equivalence that is recognized by NMPA.
Related: Previous Webinar: China’s Quality and Therapeutic Equivalence Evaluations of Generic Drugs
Contact BaiPharm to know more about China’s pharmaceutical regulations.
