On October 18, the website of the National Medical Products Administration (NMPA) reported that Li Li, Secretary of the Party Leadership Group and Director of the NMPA, chaired a meeting to discuss and launch a pilot program for segmented production of biological products. The program includes the approval of the “Pilot Work Plan for Segmented Production of Biological Products.”
During the meeting, it was emphasized that the central government places significant importance on the high-quality development of the biopharmaceutical industry. The pilot program for segmented production reform represents a crucial step for drug regulatory authorities to implement the spirit of the Third Plenary Session of the 20th Central Committee of the Communist Party. It aims to enhance international cooperation in the pharmaceutical sector, driving high-quality development in the industry. This initiative responds to the current landscape of China’s biopharmaceutical sector and regulatory practices, addressing the industry’s developmental needs. By exploring a delegated manufacturing model for certain innovative and urgently needed biological products, the program seeks to invigorate corporate research and development, promote specialized drug research and production, and enhance the capacity to supply innovative and urgently needed biological products to better meet public demand for medications.
The meeting highlighted that the pilot program will be conducted in provincial regions that align with the central government’s strategy for coordinated regional development, particularly in areas known for their biopharmaceutical industry concentration, project demands, and robust regulatory capabilities. The focus will be on the assessment and approval of segmented production of biological products, enterprise quality management, and post-market supervision. Aiming to establish a scientific and efficient management system for the entire segmented production process, the program seeks to optimize resource allocation in the biopharmaceutical industry and integrate smoothly into the global pharmaceutical innovation and supply chain.
The “Pilot Work Plan for Segmented Production of Biological Products” lays out the scope of the pilot, implementation steps, timelines, supervisory requirements, and support measures, all of which will be announced soon. The NMPA will strengthen coordination and increase support for pilot provinces across review and approval, inspection, testing, and post-market supervision, fully committing to the advancement of the pilot project.
