Member Article

Recently, the National Medical Products Administration (the "NMPA") issued the "Pilot Work Plan for the Segmented Production of Biological Products" (the "Pilot Plan"), introducing a pilot initiative for the segmented production of biological products. This represents a breakthrough in the regulation of segmented production, a long-awaited achievement in the biopharmaceutical industry. This breakthrough suggests the possibility of cross-provincial and even cross-border production of biological products, which marks the significant progress in optimizing resource allocation, reducing production costs, and improving production efficiency, and will promote the integration of China's biopharmaceutical industry into the global market, enhancing international competitiveness. In this article, we analyze the impact of the Pilot Plan, including the types of pilot products, requirements for pilot enterprises, international/cross-border collaboration, and tightened regulatory requirements. We hope to share our insights from these perspectives to provide a reference for the industry.