The General Administration of Market Supervision issued the Measures for the Administration of the Approval of Biological Products

In order to implement the newly enacted Vaccine Management Law and the newly revised Drug Administration Law and strengthen the supervision and management of the issuance of biological products, the Drug Administration has drafted and revised the Measures for the Administration of the Approval of Biological Products (hereinafter referred to as the Measures). On November 19, 2020, the 11th Meeting of the State Administration of Market Supervision and Administration in 2020 deliberated and adopted the Measures, effective March 1, 2021.Vaccines are related to people's health, public health and national security. General Secretary Xi Jinping called for improving China's vaccine management system and firmly safeguarding the safety bottom line. In the course of the revision of the Measures, the General Administration of Market Supervision and the Drug Administration resolutely implement the "four most stringent" requirements of the CPC Central Committee and the State Council on the safety of vaccine drugs, refine the principle system determined by the Vaccine Management Law and the Drug Administration Law, highlight problem orientation, draw on the advanced experience of foreign batch issuance management, and further improve the management measures such as identification, approval application and examination and inspection of biological products, and effectively safeguard the quality and supply of biological products. At the same time, strict examination and approval management, strengthen risk prevention and control, further strengthen the main responsibility of drug listing license holders, strengthen the supervision and management of the issuance of biological products. The Measures consist of eight chapters and 48 articles, the main amendments include:First, to clarify the division of responsibilities for the issuance of issues and the duties of the issuing agencies, and improve the procedures for the investigation and prosecution of products of major quality risks. It is stipulated that the provincial drug regulatory department shall be responsible for the day-to-day management of the issuing institutions within the administrative region and investigate any significant deviations that may affect the quality of the products in the production process of the enterprises. If the requirements for on-site inspection and disposal of batch issuance are refined and the drug supervision and administration department finds that there is a significant quality risk in biological products in supervision and inspection, the issuing institution shall promptly notify the issuing authority, in accordance with the results of the inspection, not to issue or suspend the issuance of the relevant products of the drug market license holder and order rectification.
Second, standardize the batch issuance management requirements, clearly issue exemptions, inspection items and frequency requirements, strengthen the management of production process deviations. In accordance with the provisions of the Vaccine Management Law, vaccines that are clearly needed to prevent or control infectious disease outbreaks or respond to emergencies shall be exempted from issuance with the approval of the State Drug Administration. The methods, inspection items and frequency of batch issuance of vaccine products and other biological products shall be specified in detail, and the batch issuance of vaccines shall be examined and sampled on a case-by-case basis. It is stipulated that relevant information such as deviations in the production process shall be submitted when issuing the declaration, and the relevant information shall be examined and carried out on-site inspection by the issuing institution.
Third, the implementation of the main responsibility of listing license holders, strengthen the full life cycle management requirements. It is stipulated that drug market license holders shall establish a complete production quality management system and continuously strengthen deviation management; that the batch of products issued shall be produced in accordance with the approved process and shall comply with the national drug standards and drug registration standards; and that the whole process of production shall conform to the requirements of the drug production quality management norms. It is clear that for products with quality problems or other safety hazards, the holder shall take measures such as stopping the sale, use and recall of defective products. At the same time, in accordance with the law, clearly approve the process of issuing illegal and illegal measures to deal with, the implementation of the most stringent supervision and the most severe penalties.
Next, the State Drug Administration will urgently formulate supporting documents to ensure that the provisions are implemented, and effectively ensure that vaccines and other biological products are safe and effective. (General Administration of Market supervision
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