On October 21, 2024, China’s NMPA rolled out a pilot plan that allows non-end-to-end and segmented production of biologics between different facilities. In the past, the NMPA insisted the entire production process be done inside a single facility. This pilot plan is in line with international practices and aims to improve productivity in the biopharmaceutical sector by outsourcing portions of the production to contract development and manufacturing organizations (CDMOs).
This pilot program will run through December 31, 2026, in selected provinces only with developed biopharma infrastructures like Shanghai, Beijing, Guangdong, and Jiangsu. Products eligible for this program are innovative biologics, monoclonal antibodies, GLP-1 receptor agonists, antibody-drug conjugates (ADCs), multi-valent vaccines, and insulin. Experienced quality assurance personnel from participating companies must be responsible for monitoring outside contract manufacturers to ensure that outsourced production abides by the same quality standards as the original drug maker.
This new pilot program is expected to reduce manufacturing costs, especially those related to complex treatments such as ADCs, which are produced in specialized facilities. The pilot also builds on previous regulatory changes. In 2019, China officially put into place the Marketing Authorization Holder system, which allows segmented production of certain drugs, such as vaccines. However, ambiguity over what products are eligible for segmented manufacturing has led many to invest in full-scale facilities to gain approval from regulators. This has curtailed the intended effect of the MAH system. This latest pilot could give more clarity and support to biologics manufacturers looking to utilize outsourcing more effectively in China.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.