Simplified Chinese
Xinhua News Agency reports: Vaccine management will be governed by a separate law.
Release date:
2019-02-28
Author:
Source:
CyberBlue
Abstract
According to Xinhua News Agency, the draft Vaccine Administration Law was submitted for the first time to the seventh session of the Standing Committee of the 13th National People’s Congress. Meeting Deliberation.
The draft establishes a separate law on vaccine management, highlighting the distinctive features of this field and strengthening risk management, end-to-end control, stringent oversight, and collaborative governance. It aims to ensure the safety, efficacy, and standardized administration of vaccines.
The CPC Central Committee and the State Council attach great importance to vaccine regulation and have called for accelerating the establishment of a long-term, robust regulatory framework for vaccines and pharmaceuticals. The enactment of a separate law on vaccine management will help further enhance the authority and stability of vaccine‑related regulatory measures.
▍Establish a comprehensive, end-to-end vaccine management system
An official from the Policy and Regulations Department of the National Medical Products Administration stated that in 2005, the State Council promulgated the Regulations on the Circulation and Immunization of Vaccines, which were subsequently revised in 2016. The draft Vaccine Management Law now submitted for deliberation clearly sets forth, in legal terms, provisions covering vaccine research and development, manufacturing, distribution, immunization, compensation, and indemnification, thereby helping to establish a systematic, end-to-end vaccine management framework.
The official stated that the draft upholds the strategic and public‑interest nature of vaccines, incorporating the research, development, production, and stockpiling of vaccines for the prevention of major diseases into the national strategy.
For example, the state could formulate a development plan and industrial policies for the vaccine industry, encouraging large-scale, intensive production; establish an inter‑departmental coordination mechanism to ensure unified oversight of vaccine safety; and further strengthen the national immunization program, explicitly instituting a no‑fault compensation scheme for adverse reactions.
▍Implement mandatory liability insurance for vaccines
To ensure the strictest possible oversight, the draft proposes that the state adopt an access regime for vaccine production that is more stringent than that applied to the manufacture of ordinary pharmaceuticals. It stipulates that vaccines may generally not be outsourced for production and requires that legal representatives, principal persons in charge, and other personnel in key positions maintain a good credit record and possess appropriate professional qualifications and relevant work experience.
Implement a vaccine lot‑release system and mandatory liability insurance for vaccines. In addition, it also stipulates that vaccines… Clinical trial It shall be implemented or organized by tertiary medical institutions or disease control agencies at or above the provincial level.
With respect to the entire process of vaccine research and development, production, distribution, and immunization, the draft’s relevant provisions clearly assign responsibilities to all parties involved.
▍Conduct quality monitoring of marketed vaccines
The State has established a comprehensive, information-based traceability system for vaccines and conducts quality monitoring and analysis of vaccines that have been approved for market release. During the distribution phase, disease prevention and control institutions are responsible for delivering vaccines to vaccination units; no other entities or individuals may supply vaccines directly to such units.
The draft clarifies regulatory responsibilities, strengthens capacity-building in oversight, and imposes strict penalties on illegal activities. It mandates that drug regulatory authorities and health administrative departments establish information-sharing mechanisms and implement a unified system for the public disclosure of vaccine safety information; it also calls for the development of a professional, specialized inspector corps at both the national and provincial levels; and it reinforces accountability for regulatory agencies and local governments, reflecting the principle of imposing severe penalties for vaccine-related violations.
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