To implement the newly formulated Vaccine Administration Law and the newly revised Drug Administration Law, and reinforce the supervision and administration of the lot release of biological products, NMPA drafted the Provisions for the Lot Release of Biological Products (hereinafter referred to as the Provisions). The Provisions has been adopted upon deliberation at the 11th Executive Meeting of the State Administration for Market Regulation on November 19, 2020, and shall go into effect as of March 1, 2021.

Vaccines are of great significance to people's health, public health safety and national security. General Secretary Xi Jinping requires to improve China's vaccine administration system and resolutely hold on to the bottom line of safety. During the revision process of the Provisions, drawing on the advanced experience of foreign lot release administration, the State Administration for Market Regulation and the NMPA resolutely implemented the "Four Strictest" requirements of the Party Central Committee and the State Council on the drug safety of vaccines, elaborated the principles and systems established by the Vaccine Administration Law and the Drug Administration Law in a practical way for solving problems, and further improved the administrative measures for determination of competent agencies for lot release of biologicals, as well as for the corresponding application, review and inspection processes, to effectively ensure the quality and supply of biological products. At the same time, strict approval administrative measures are adopted to fortify risk prevention and control, further consolidate the principal responsibility of drug marketing authorization holders, and reinforce the supervision and administration in this domain. These Provisions contain 48 Articles in eight Chapters, of which the major revisions include:

1. Clarifications of the assignment of responsibilities for lot release agencies, and improvement of the procedures for investigating and handling products with serious quality risks. Additional clauses provide that the provincial drug regulatory departments shall be responsible for the daily management of lot release agencies in the administrative area, while investigating major deviations that may affect product quality in the production process of the enterprise. The requirements for on-site inspection and handling in relation to lot release are specified, clarifying that if the drug regulatory department spots biological products with serious quality risks during the supervision and inspection, it should promptly notify the lot release agency based on the inspection results to reject or suspend the lot release of application by relevant drug marketing authorization holders and order for rectification.

2. Standardization of administrative requirements for lot release, clarifying the exemptions, inspection items and frequency requirements for lot release, and emphasizing control over production process deviations. According to the Vaccine Administration Law, vaccines that are urgently needed to prevent and control infectious diseases or respond to emergencies shall be exempted, with NMPA approval, from lot release. Detailed regulations have been made on the lot release methods, inspection items, and frequency for vaccines and other biological products, and it is required that the lot release of vaccines should be subject to dossier review and sampling inspection. It is stipulated that relevant dossiers such as production process deviation should be submitted while applying for lot release, to facilitate the competent agency's review and on-site inspections.

3. Implementation of the principal responsibilities of the marketing authorization holders, emphasizing life-cycle management requirements. Additional clauses provide that the drug marketing authorization holders should build up a complete production quality management system and deviation control; lot release products should be produced in accordance with approved processes and should meet national drug standards and drug registration standards; and the whole process of production should conform to drug GMP requirements. It is clarified that for products with quality problems or other safety hazards, the holders should take immediate measures such as stopping sales and use, and recalling defective products, etc. At the same time, the handling measures for violations of laws and regulations in the lot release process are clearly defined in accordance with the law, to implement the requirement of strictest supervision and strictest punishment.

In the next step, the NMPA will quickly formulate supporting documents to ensure that all regulations are fully implemented and that the biological products such as vaccines are safe and effective.