NMPA Approves Jilin and Hainan to Conduct Pilot Programs for Optimizing the Review and Approval Procedures for Drug Supplemental Applications

Recently, the National Medical Products Administration (NMPA) has issued the Official Reply on Approving the Jilin and Hainan Medical Products Administrations to Conduct Pilot Programs for Optimizing the Review and Approval Procedures for Drug Supplemental Applications (the "Reply").

According to the Reply, the NMPA approves the Jilin and Hainan Medical Products Administrations to carry out the pilot reform of optimizing the review and approval procedures for drug supplemental applications. The Reply requires the two provincial authorities to strictly organize and implement the pilot programs in accordance with the Work Plan for the Pilot Reform of Optimizing the Review and Approval Procedures for Drug Supplemental Applications, and to strengthen organization and management and carry out relevant pre-filing services pursuant to the Circular of the General Office of the National Medical Products Administration on Strengthening the Management of Pilot Programs for Optimizing the Review and Approval Procedures for Drug Supplemental Applications and the Circular of the National Medical Products Administration on the Pilot Program for Optimizing the Review and Approval Procedures for Supplemental Applications of Overseas-manufactured Drugs.



(Source: https://www.nmpa.gov.cn/xxgk/fgwj/gzwj/gzwjyp/20251210171806128.html)

Note: The link to the Chinese official website of the document is for your reference.