The National Medical Products Administration (NMPA) has given its stamp of approval to the “Pilot Work Plan for Phased Manufacturing of Biological Products,” a document that outlines a comprehensive framework for the phased production of certain innovative and urgently needed biological products through contract manufacturing. The plan, anticipated to be released shortly, delineates the scope of pilot projects, implementation steps, timeline, supervisory and management requirements, and security measures.
Aimed at fostering the segmented production of biological products, the pilot work will initially be executed in provincial-level administrative regions that are poised to take on segmented production tasks. The plan also targets regions with a concentrated biopharmaceutical industry, real project demand, and robust regulatory capacity for biological products. The goal is to establish a scientific and efficient management system that encompasses the entire process of segmented production, from review and approval to enterprise quality management and post-market supervision.
This initiative is expected to optimize resource allocation within the biopharmaceutical industry and facilitate orderly integration into the global pharmaceutical innovation, industrial, and supply chains, thereby enhancing the industry’s competitiveness and meeting clinical needs more effectively.- Flcube.com
