In order to implement the newly formulated "Vaccine Administration Law" and the newly revised "Drug Administration Law" and strengthen the supervision and management of the batch issuance of biological products, the Food and Drug Administration drafted and revised the "Management Measures for the Batch Issuance of Biological Products" (hereinafter referred to as the "Methods") ).
On November 19, 2020, the 11th Executive Meeting of the State Administration for Market Regulation in 2020 deliberated and approved the "Measures", which will be implemented on March 1, 2021.
Vaccines concern the health of the people, public health safety and national security.
General Secretary Xi Jinping asked to improve my country's vaccine management system and firmly maintain the bottom line of safety.
During the revision process of the Measures, the State Administration for Market Regulation and the Food and Drug Administration resolutely implemented the “four strictest” requirements of the Party Central Committee and the State Council on vaccine drug safety, and refined the principles and systems established by the Vaccine Administration Law and the Drug Administration Law. Highlight the problem orientation, learn from the advanced experience of foreign batch issuance management, and further improve the management measures of biological product batch issuance agency determination, batch issuance application, review and inspection, and effectively guarantee the quality and supply of biological products.
At the same time, strict approval management, strengthen risk prevention and control, further consolidate the main responsibility of drug marketing license holders, and strengthen the supervision and management of the batch issuance of biological products.
The "Measures" has eight chapters and 48 articles, and the main amendments include:
The first is to clarify the responsibilities of batch issuance and the responsibilities of batch issuance agencies, and improve the procedures for investigating and handling products with major quality risks.
It is added that the provincial drug regulatory department is responsible for the daily management of the batch issuing agencies in the administrative area, and investigating major deviations that may affect product quality in the production process of the enterprise.
Refine the requirements for site inspection and disposal of the batch, and clarify that if the drug supervision and administration department finds that there are major quality risks in biological products during the supervision and inspection, it should promptly notify the batch issuing agency based on the inspection results to not grant the relevant products of the drug marketing license holder Batch issuance or suspension of batch issuance and order for rectification.
The second is to standardize batch issuance management requirements, clarify batch issuance exemptions, inspection items and frequency requirements, and strengthen production process deviation management.
According to the "Vaccine Management Law", vaccines that are urgently needed to prevent and control infectious diseases or respond to emergencies shall be exempted from approval by the State Drug Administration.
Detailed regulations have been made for the batch issuance methods, inspection items and frequency of vaccine products and other biological products, and it is required that vaccine batches shall be subject to data review and sampling inspection batch by batch.
It is stipulated that relevant materials such as production process deviations should be submitted when the batch issuance declaration, and the batch issuing agency shall review the relevant materials and carry out on-site inspections.
The third is to implement the main responsibility of the listing license holder and strengthen the management requirements for the whole life cycle.
It is added that drug marketing license holders should establish a complete production quality management system and continue to strengthen deviation management; batch-issued products should be produced in accordance with approved processes and should comply with national drug standards and drug registration standards; the entire production process should be consistent with drugs The requirements of production quality management standards.
It is clear that for products with quality problems or other safety hazards, the holder should take measures such as stopping sales and use, and recalling defective products.
At the same time, the handling measures for violations of laws and regulations in the process of approval and issuance are clearly defined in accordance with the law, and the strictest supervision and strictest punishment requirements are implemented.
In the next step, the State Food and Drug Administration will expeditiously formulate supporting documents to ensure that various regulations are implemented, and to ensure the safety and effectiveness of biological products such as vaccines.