On October 21, 2024, the China National Medical Products Administration (NMPA) released a pilot plan that allows non-end-to-end manufacturing of biologics. The NMPA has a longstanding position to require an end-to-end production of biologics in a single manufacturing location. In other words, the drug substance and the drug product shall in principle be produced at the same manufacturing facility. The domestic biopharmaceutical industry has been advocating a relaxation of this position, especially since foreign biologics manufacturers have been allowed to manufacture the biological drug substance and the drug product in separate manufacturing locations.
This pilot plan is applicable in provinces selected by the NMPA or having a cluster of biopharmaceutical companies and being experienced in supervising biologics manufacturers. The eligible product categories include innovative biologics, biologics that are urgently needed, multivalent vaccines, monoclonal antibodies, ADCs, GLP-1 receptor agonists, and insulin. Marketing authorization applicants or foreign biologics manufacturers that are interested in relocating the manufacture of their products to China can apply with the provincial MPA by December 31, 2025. The applicants must assign at least two experienced Quality Assurance (QA) personnel to oversee the contract manufacturing organization’s (CMO) manufacturing operations and ensure that the CMOs of drug substance and drug products share identical quality management systems with the applicants. Upon the end of the pilot program on December 31, 2026, the NMPA will likely be ready to allow all biologics to be manufactured with a non-end-to-end process.
About our practice
Ropes & Gray’s internationally recognized Asia life sciences practice offers integrated and comprehensive counsel to leading investment funds and global pharmaceutical, biotechnology, medical device and consumer product companies on doing business in one of the world’s fastest growing and most challenging regions. For further information on our Asia life sciences practice, click here.
Subscribe to Ropes & Gray Viewpoints by topic here.
Stay Up To Date with Ropes & Gray
Ropes & Gray attorneys provide timely analysis on legal developments, court decisions and changes in legislation and regulations.
Stay in the loop with all things Ropes & Gray, and find out more about our people, culture, initiatives and everything that’s happening.
We regularly notify our clients and contacts of significant legal developments, news, webinars and teleconferences that affect their industries.