Shanghai: Strengthening Targeted Regulation in Key Areas and Key Varieties
2026-11-09 14:57:57
According to CoinMeta, the Shanghai Food and Drug Safety Commission has issued the "15th Five-Year Plan for Ensuring Drug Safety and Promoting High-Quality Development of the Pharmaceutical Industry in Shanghai." The plan proposes to strengthen targeted supervision in key areas and for key varieties of drugs. It aims to improve the implementation of responsibilities for entrusted production and mechanisms for shared risk management, as well as to reinforce the primary responsibilities for quality and safety and the obligations stipulated in quality agreements for entrusted production. The plan also calls for more thorough inspections of vaccine manufacturing enterprises that are currently in production. Full coverage supervision will be implemented for vaccines, blood products, advanced therapeutic drugs, sterile drugs, special drugs, and products produced in segments, with a focus on risk prevention and control in critical areas such as data reliability, sterility assurance, deviation management, and change management. Supervision over key medical device varieties, including implantable devices, sterile devices, and those selected through centralized procurement, will be enhanced, with a "one-product, one-strategy" approach to regulating innovative medical devices. Inspections of key processes such as the procurement of critical raw materials, finished product testing, and release before leaving the factory will also be intensified. Additionally, actions to improve the production quality management systems of cosmetics companies will be carried out, with increased supervision over special cosmetics and those containing new raw materials, as well as strengthened management of raw materials.
Source:Jin10 Data
This content is for market information only and does not constitute investment advice.
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