The Center for Drug Evaluation (CDE) has released the “NMPA Drug Review Timekeeping Suspension and Resumption Management Specifications” (trial rules), which take immediate effect. The document outlines six specific cases of timekeeping suspension and corresponding operations for resumption.
Suspension and Resumption Cases
- Time Occupied by Applicant’s Objection and Expert Argumentation:
- If the review conclusion is “not approved,” the CDE will publicize the reason on the 药品注册申请人之窗 and suspend timekeeping. The applicant may raise an objection within 15 days from the date of publicity. If no objection is raised, the review time will resume. During the objection period, if the applicant proposes expert argumentation, the CDE will suspend timekeeping and proceed according to relevant procedures.
- Time Taken by Applicant to Supplement Information, Rectify After Verification, and Check Production Process, Quality Standards, and Instructions:
- Review timekeeping will be suspended from the date of issuing the notice of supplementary information. Timekeeping resumes after the CDE confirms receipt of all supplementary research materials. If a drug inspection is required, timekeeping resumes after the inspection report is accepted, except for priority evaluation varieties and clinically urgent overseas new drugs. For verification and rectification, the CDE will confirm the suspension time and resume it after receiving the verification report.
- Time Taken by Delayed Inspection, Examination, Expert Consultation, etc., Due to the Applicant:
- If the verification and inspection report is not received 40 days before the expiration of the review time limit, the CDE will suspend timekeeping and resume it after receiving the report.
- Time Occupied During Suspension of Review and Approval Procedure:
- If patent issues are involved, the “Implementation Measures for a Drug Patent Early Dispute Resolution Mechanism” shall prevail. For other similar varieties of chemical generic drugs that have not received a verdict within the waiting period, are judged to fall within the scope of relevant patent protection, and are within the exclusive market period, timekeeping will be suspended after the completion of the technical review and resumed before the expiration of the waiting period/patent period/exclusive market period. Associated varieties require synchronous timekeeping suspension and resumption.
- Time Occupied by Overseas Verification:
- If the verification report is not received 40 days before the expiration of the review time limit, the CDE will suspend timekeeping and resume it after receiving the report.
Applicability
The document applies to the registration application of all types of drugs (including APIs) and related applications of pharmaceutical excipients and drug packaging materials, including marketing license applications, supplementary applications, re-registration applications of imported drugs, quality consistency evaluation applications, etc. Generally, timekeeping is not suspended during the review of a drug clinical trial application, except for those entering the objection procedure or when a casual inspection is initiated.-Fineline Info & Tech
