According to Xinhua News Agency, the draft vaccine management law was first submitted to the seventh meeting of the 13th NPC Standing Committee for deliberation.
The draft separate legislation on vaccine management, highlighting the characteristics of vaccine management, strengthening vaccine risk management, overall control, strict supervision and social co-governance, and practically guarantee vaccine safety, effectiveness and standardized vaccination.
The Party Central Committee and the State Council attach great importance to vaccine supervision and work, and demand to accelerate the improvement of the long-term mechanism of vaccine and drug supervision. Separate legislation for vaccine management is conducive to further improving the authority and stability of vaccine management measures.
▍Establish a full-chain vaccine management system
According to the person in charge of the Policy and Regulation Department of the State Food and Drug Administration, the State Council promulgated the "Regulations on the Administration of Vaccine Circulation and Vaccination" in 2005, which was revised in 2016. The draft vaccine management law submitted for review this time clearly stipulates the legal form of vaccine development, production, distribution, vaccination, compensation and compensation, which is conducive to the establishment of a systematic and full-chain vaccine management system.
The person in charge said that the draft adheres to the strategic and public welfare of vaccines and incorporates the development, production and storage of vaccines against major diseases into the national strategy.
For example, it is proposed that the country formulate development plans and industrial policies for the vaccine industry to encourage large-scale and intensive production; establish a departmental coordination mechanism to coordinate and coordinate vaccine safety supervision; further strengthen the national immunization planning system and clearly implement a fault-free compensation mechanism for abnormal reactions.
▍Implement mandatory vaccine liability insurance
In order to reflect the strictest supervision, the draft proposes that the state implement a stricter access system for vaccine production than for general pharmaceutical production. Vaccines are generally not allowed to be entrusted for production, and legal representatives, main responsible persons, and other key position personnel must have good credit records, and have corresponding professional backgrounds and professional experience.
Implement a vaccine batch issuance system and compulsory insurance for vaccine liability. In addition, it also stipulates that clinical trials of vaccines should be carried out or organized by third-level medical institutions or disease control institutions at or above the provincial level.
Regarding the entire process of vaccine development, production, distribution, and vaccination, the relevant provisions of the draft clearly implement the responsibilities of all parties.
▍Quality tracking of marketed vaccines
The state implements a complete information traceability system for vaccines, and conducts quality tracking and analysis on the marketed vaccines. In the circulation process, disease prevention and control organizations organize the distribution of vaccines to vaccination units, and other units or individuals may not supply vaccines to vaccination units.
The draft clarifies supervisory responsibilities, strengthens supervisory capacity building, and severely cracks down on illegal activities. Requires drug regulatory authorities and health administrative departments to establish information sharing mechanisms and implement a unified system for the publication of vaccine safety information; build a team of professional and specialized inspectors at the national and provincial levels; strengthen accountability of regulatory authorities and local governments to reflect vaccine violations Heavier punishment principle.