The National Medical Products Administration (NMPA) has released the “Drug Conditional Approval Filing Review and Approval Procedures (trial)(revised draft proposal)”. This revised draft optimizes and adjusts the working procedures and requirements for conditional approvals compared to the trial version implemented since 2020.
Enhanced Communication and Conditional Approval Requirements
The revised draft requires applicants to communicate with the Center for Drug Evaluation (CDE) regarding the marketing conditions, post-marketing research work, and research completion deadlines for products intended for conditional approval. Confirmatory research must have been initiated when applying for Class II meetings, while Class I meetings can be applied for those that have been awarded breakthrough therapy designation (BTD) status. After submitting a conditional market filing, applicants who meet the relevant conditions can be transferred to the regular review process during the review period based on the confirmatory research results that have been completed or are about to be completed.
Research Work Deadlines and Reporting Requirements
The deadline for completing research work after conditional approval should not exceed 4 years in principle, and a written report on the progress of research after listing should be submitted to the CDE every 12 months. If the clinical trial with the attached conditions cannot be conducted due to objective reasons, a supplementary application can be submitted. If the evaluation meets the requirements, the research protocol can be modified.
Continuation of Research and Sales Suspension
If the clinical trial of the drug with the attached conditions cannot be completed on schedule after being approved for listing, a supplementary application may be submitted. Those who meet the requirements after evaluation are allowed to continue the research. During the continuation of the research period, the sales of relevant drugs will be suspended. For patients already in the clinics, with informed consent, the drugs can continue to be provided until the patients complete the treatment course.
Market Exclusivity and Limitations on Similar Applications
It is worth noting that the revised draft clearly states that drugs awarded conditional market approval in China will not be released as reference preparations in principle until they are converted to routine approval. After a particular drug is conditionally approved for marketing, in principle, the NMPA will no longer allow other similar clinical trial applications for molecules with the same mechanism, target, and indication. This provides a certain market exclusivity opportunity for new drugs that have been conditionally approved in the future.-Fineline Info & Tech
