The National Medical Products Administration (NMPA) has unveiled the “Pilot Work Plan for Optimizing the Review and Approval Procedures of Supplementary Drug Applications,” aimed at enhancing the efficiency of the drug review and approval process. This initiative seeks to streamline the supplementary filing review process for pharmaceutical companies.
Under the pilot program, eligible provincial medical product administration bureaus will be tasked with providing pre-guidance, verification, inspection, and filing services for companies intending to make significant changes to drug approvals within their jurisdictions. This approach is grounded in the principles of “early intervention, one enterprise, one policy, full process guidance, and research and review linkage.”
To facilitate this pilot, the NMPA’s Center for Drug Evaluation, Center for Food and Drug Inspection, and the National Institutes for Food and Drug Control will establish an exchange mechanism with participating provincial units. This collaboration will include training, technical support, and information system assistance for front-end services, while also exploring the creation of a cohesive team, network, and set of standards to enhance coordination throughout the review process.- Flcube.com
