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国家药监局:部署生物制品分段生产改革试点工作

National Medical Products Administration: Deploys pilot work on segmented production reform of biological products.

Breakings ·  14:25

On October 18, the National Medical Products Administration reviewed and approved the "Biological Product Segmented Production Pilot Work Plan". This pilot work is based on the current situation and regulation of China's biomedical industry, actively responding to the needs of industry development, exploring the segmented production of some innovative and clinically urgently needed biological products through commissioned production. This will help further stimulate the research and development innovation vitality of enterprises, promote the specialization of drug research and development production, enhance the level of product quality and safety assurance, strengthen the supply guarantee capability of innovative and clinically urgently needed biological products, and meet the medication needs of the general public. The pilot work will focus on the evaluation and approval of segmented production biological products, enterprise quality management, post-market supervision, etc., exploring the establishment of a scientific and efficient segmented production full-process management system, promoting the optimization of resource allocation in the biomedical industry, orderly integrating into the international industry chain, and achieving high-quality development.

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