????Xinhua News Agency, Beijing, December 23rd (Reporter Zhao Wenjun, Yang Weihan) The draft vaccine management law was first submitted to the Seventh Session of the 13th the National People’s Congress Standing Committee (NPCSC) for deliberation on the 23rd. The draft legislates separately on vaccine management, highlights the characteristics of vaccine management, strengthens risk management, whole-process control, strict supervision and social co-governance of vaccines, and effectively ensures safe, effective and standardized vaccination of vaccines.
????The CPC Central Committee and the State Council attached great importance to vaccine supervision and demanded that the long-term mechanism of vaccine drug supervision be improved quickly. Separate legislation on vaccine management is conducive to further improving the authority and stability of vaccine management measures.
????The relevant person in charge of the Policy and Regulation Department of National Medical Products Administration introduced that in 2005, the State Council promulgated the Regulations on the Administration of Vaccine Circulation and Vaccination, which was revised in 2016. The draft vaccine management law submitted for deliberation clearly stipulates vaccine development, production, circulation, vaccination, compensation and compensation in legal form, 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 nature of vaccines and incorporates the development, production and storage of vaccines to prevent major diseases into the national strategy. For example, it is proposed that the state formulate the vaccine industry development plan and industrial policy to encourage the scale and intensification of production; Establish a departmental coordination mechanism to coordinate vaccine safety supervision; Further strengthen the national immunization planning system and clearly implement the no-fault compensation mechanism for abnormal reactions.
????In order to reflect the strictest supervision, the draft proposes that the state should implement a stricter access system for vaccine production than for general drug production. Vaccines are generally not required to be commissioned for production, and the legal representative, principal responsible person and other key personnel are required to have good credit records, corresponding professional background and working experience. Implement a vaccine batch issuance system and compulsory vaccine liability insurance. In addition, it also stipulates that clinical trials of vaccines should be implemented or organized by tertiary medical institutions or disease control institutions at or above the provincial level.
????For the whole process of vaccine development, production, circulation and vaccination, the relevant provisions of the draft clearly implement the responsibilities of all parties. The state implements the whole-process information traceability system of vaccines, and carries out quality tracking analysis of vaccines on the market; In the circulation link, the disease prevention and control institutions shall organize the distribution of vaccines to the inoculation units, and other units or individuals shall not supply vaccines to the inoculation units.
????The draft clarifies regulatory responsibilities, strengthens regulatory capacity building, and severely cracks down on illegal activities. Require drug regulatory authorities and health administrative departments to establish an information sharing mechanism and implement a unified announcement system for vaccine safety information; Building a team of professional and specialized inspectors at the national and provincial levels; Strengthen the accountability of regulatory authorities and local governments, reflecting the principle of heavier punishment for vaccine violations.