{"id":36985,"date":"2025-07-09T12:40:21","date_gmt":"2025-07-09T04:40:21","guid":{"rendered":"https:\/\/flcube.com\/?p=36985"},"modified":"2025-07-09T12:40:22","modified_gmt":"2025-07-09T04:40:22","slug":"nmpa-updates-review-procedures-for-conditional-drug-marketing-approval-applications","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=36985","title":{"rendered":"NMPA Updates Review Procedures for Conditional Drug Marketing Approval Applications"},"content":{"rendered":"\n
The National Medical Products Administration (NMPA) this week released a revised draft proposal for the “Review and Approval Procedures for Drug Conditional Marketing Approval Application (Trial)”, alongside a policy interpretation.<\/p>\n\n\n\n
Application Process<\/strong> Drugs meeting conditional approval criteria can apply for authorization during clinical trials or real-world evidence studies by submitting an application to the Center for Drug Evaluation (CDE) under the NMPA. For drugs urgently needed for public health, a recommendation from the National Health Commission or other relevant authorities is required. Vaccines for major public health emergencies must target diseases classified as Grade II (major) or Grade I (extraordinarily severe) under the “Public Health Emergency Response Regulation” and the “National Public Health Emergency Response Plan.”<\/p>\n\n\n\n
Post-Approval Requirements<\/strong> Upon approval, the drug will receive a marketing authorization certificate specifying its validity period, post-marketing study requirements, and completion timelines, which generally must not exceed four years from conditional approval. The marketing authorization holder must implement risk management measures and submit annual progress reports on post-marketing studies via the Development Safety Update Report (DSUR) to the CDE within 12-month intervals.<\/p>\n\n\n\n
Additional Provisions<\/strong> For other investigational drugs sharing the same mechanism, target, or indication, if their pivotal clinical trials for conditional approval have been agreed upon with the CDE, research may continue as planned. However, sponsors must closely monitor risks. Once one drug in the class achieves full approval, other conditional approval applications for the same category will no longer be accepted. Drugs under conditional approval cannot be listed as reference products until converted to full approval. If a drug gains full approval while still including conditionally approved indications, it may qualify as a reference product if it meets selection criteria.-Fineline Info & Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"