The National Medical Products Administration (NMPA) has officially released the “Pilot Work Plan for Phased Manufacturing of Biological Products,” which is set to take effect immediately and continue through December 31, 2026. The plan calls for applicants and drug registration holders interested in participating in the pilot program to submit their pilot applications to the provincial medical products administration bureau by December 31, 2025. These bureaus will then conduct a preliminary selection of pilot enterprises and varieties, developing detailed work plans based on the “one product, one policy” principle.
The document outlines that the pilot varieties for phased production should be innovative biological products, clinically urgently needed biological products, or other products specified by the NMPA, including multivalent vaccines, antibody-based biological products, antibody-conjugated biological products, glucagon-like peptide-1 based biological products, and insulin-based biological products. The pilot areas encompass provincial-level administrative regions identified in the Party Central Committee and the State Council’s regional coordinated development strategy for exploring phased manufacturing tasks for biological products, as well as regions with a concentrated biopharmaceutical industry, real project demand, and strong regulatory capacity for biological products.
Applicants for the pilot program must have self-developed varieties and be well-versed in the product’s research and development, production process, and quality control. They are required to establish and improve drug quality management systems and be legally responsible for the safety, effectiveness, and quality controllability of the drug throughout its development, production, operation, and use. Entrusted production enterprises should possess a robust drug quality assurance system and relevant commercial production experience for biological products. They must organize production in compliance with drug GMP, strictly implement quality agreements and commissioned production agreements, and actively cooperate with the holder’s on-site audits and spot checks.
This initiative by the NMPA underscores China’s commitment to fostering innovation in the biopharmaceutical sector and enhancing the efficiency and quality of biological product manufacturing.- Flcube.com
