General Administration of market supervision: public consultation on vaccine management law, severe punishment of illegal acts, full process information traceability

In order to protect public health, promote public health and maintain national security, in accordance with the decision and deployment of the Party Central Committee and the State Council, and in accordance with the legislative requirements of the Standing Committee of the National People's Congress, the State Administration of market supervision, the State Drug Administration, the state Health Commission and other departments are jointly responsible for the drafting of the vaccine management law Now, the vaccine management law of the people's Republic of China (Draft for comments) drafted by the State Drug Administration in consultation with the National Health Commission and its instructions are published The public can put forward opinions and suggestions through the following ways and means: 1 Email the opinions and suggestions to: fgs@saic.gov.cn 2、 Mail the opinions and suggestions to the regulatory department of the State Administration of market supervision, No 8, sanlihedong Road, Xicheng District, Beijing 100820, and mark the words "feedback opinions of the vaccine management law of the people's Republic of China (Draft for comments)" on the envelope The deadline for feedback is November 25, 2018 Appendix 1 of November 11, 2018: vaccine administration law of the people's Republic of China (Draft for comments) Chapter I General Provisions Article 1 [legislative purpose] this law is formulated for the purpose of ensuring vaccine safety, effectiveness, accessibility, standardizing vaccination, ensuring and promoting public health and safeguarding national security Article 2 [scope of application] This Law shall be abided by when engaging in vaccine research, production, distribution, vaccination, supervision and administration within the territory of the people's Republic of China The term "vaccine" as used in this Law refers to the prophylactic biological products used for human body immunization in order to prevent and control the occurrence and prevalence of diseases Vaccines can be divided into two categories: immunization and non immunization vaccines Article 3 [principles of management] vaccine management shall follow the requirements of ethics, science and the rule of law, adhere to risk management, full process control, scientific supervision and social co governance, and implement the strictest supervision Article 4 the State implements a planned vaccination system and an expanded immunization program Article 5 [industrial policies] the state adheres to the strategic and public welfare nature of vaccines, formulates development plans and industrial policies for the vaccine industry, increases financial investment, implements preferential tax policies, supports basic research and applied research, guides the optimization of industrial structure, formulates pricing mechanism in line with the development of the industry, and promotes the development and innovation of vaccines The State shall incorporate vaccine research and development for the prevention of major diseases into its national strategy and give priority to support The State implements strict access management for vaccine manufacturers, guides and encourages large-scale and intensive development of vaccine manufacturers, supports enterprises to improve vaccine production process and continuously improve vaccine quality Article 6 [listing license holder system] the vaccine shall be subject to the listing license holder system The holder of the vaccine marketing license shall be a pharmaceutical manufacturer with vaccine production capacity The holder of vaccine marketing license shall be responsible for the safety, effectiveness and controllable quality of vaccine development, production and circulation according to law To engage in vaccine research and development, production, distribution and vaccination activities, we should abide by laws, regulations, standards and norms, ensure the authenticity, accuracy, integrity and traceability of the data in the whole process, bear the main responsibility, and accept social supervision Article 7 [division of Responsibilities] the drug regulatory department under the State Council shall be responsible for the supervision and administration of vaccine safety nationwide, formulate standards, norms and supervise the implementation, and undertake the supervision and administration of vaccine development, marketing license and vaccine batch issuance The administrative department of health under the State Council shall be in charge of the supervision and administration of vaccination nationwide The Department of science and technology under the State Council shall be in charge of the biosafety management related to vaccine development and production The industry and Information Technology Department of the State Council shall be responsible for the management of the vaccine industry and formulate the development plan and industrial policies for the vaccine industry Other relevant departments under the State Council shall be responsible for the supervision and administration of vaccines within the scope of their respective duties The drug regulatory departments of provinces, autonomous regions and municipalities directly under the central government shall supervise and manage the vaccine production activities within their respective administrative regions, and supervise and guide the work of vaccine quality supervision and management in vaccine circulation and vaccination The municipal departments divided into districts and the drug regulatory departments at the county level shall be responsible for the inspection and punishment of the quality of vaccine use links within their respective administrative areas The administrative department of health at or above the county level shall supervise and manage the vaccination, relevant storage and transportation within its own administrative area Article 8 [vaccine coordination mechanism] the State Council shall establish a multi department vaccine management coordination mechanism, coordinate major policies such as vaccine industry layout, industry planning, production and circulation, quality and safety, supply and reserve, vaccination, compensation and compensation, regularly analyze vaccine safety situation and promote vaccine safety supervision Article 9 [Responsibilities of local governments] the local people's governments at or above the county level shall be responsible for the supervision and management of vaccine safety in their respective administrative regions, lead, organize and coordinate the supervision and management of vaccine safety in their respective administrative regions and the response to vaccine safety emergencies, establish the supervision and management mechanism and information sharing mechanism of health vaccine safety, and incorporate vaccine safety into their own work In the national economic and social development plan at the same level, the funds for vaccine safety work shall be included in the financial budget at the same level, and the capacity-building of vaccine safety supervision shall be strengthened to provide guarantee for vaccine safety work The people's governments of provinces, autonomous regions and municipalities directly under the central government shall establish a coordination mechanism for vaccine management, strictly control vaccine production, circulation and vaccination safety, and regularly carry out analysis of vaccine safety situation Article 10 [traceability system] the whole process information-based vaccine traceability system is implemented in the country The drug regulatory department under the State Council shall, together with the health administrative department under the State Council, formulate unified standards and specifications for vaccine traceability, establish a national electronic traceability platform, integrate the whole process of production, circulation, use and other traceability information, and achieve vaccine quality and safety traceability The holder of vaccine marketing license shall establish a vaccine information traceability system to realize the long-term traceability and verification of the whole process of production, storage, transportation and use of the smallest vaccine packaging unit Disease prevention and control institutions and vaccination units shall truthfully record the circulation and use of vaccines according to law, and provide traceability information according to standards Article 11 people's governments at all levels shall strengthen the publicity and education of vaccine safety, and carry out the popularization of vaccine safety laws and regulations, vaccine safety standards and vaccination knowledge The news media shall carry out the public welfare publicity of vaccine related laws, regulations, standards and vaccination knowledge, and conduct public opinion supervision over the illegal acts of vaccines The publicity reports of vaccines shall be scientific, objective and fair Article 12 [social co governance] vaccine industry organizations shall strengthen industry self-discipline, establish and improve industry norms, promote the construction of industry integrity system, guide and urge enterprises to carry out production and operation activities according to law, and promote self-management, self-regulation, self purification and self-improvement of vaccine industry Third party organizations are encouraged to provide technical consultation and compliance guidance services for vaccine marketing license holders Units and individuals that have made significant contributions to vaccine creation, disease prevention and control, and supervision and management shall be commended and rewarded in accordance with the relevant provisions of the state Any organization or individual has the right to report the illegal acts of vaccines, learn about vaccine information from relevant departments according to law, and put forward opinions and suggestions on vaccine supervision and management Chapter II vaccine development and marketing license Article 13 [marketing license system] vaccine marketing shall be approved by the drug regulatory department under the State Council, and the certificate of drug marketing license shall be obtained When applying for vaccine marketing license, sufficient and reliable research data and information shall be provided Article 14 [biosafety and management of bacterial strains and cells] vaccine development units and marketing license holders shall strictly control biosafety risks, strengthen biosafety management of pathogenic microorganisms such as bacterial strains, protect the health of operators and the public, and ensure that bacterial strains are used for proper purposes The history, biological characteristics and generations of bacterial strains and cell lines used in vaccine development, production and testing shall be clearly defined, and detailed files shall be established to ensure clear and traceable sources Article 15 [examination and approval of clinical trials and management of institutions] to carry out clinical trials of vaccines, the examination and approval of the ethics committee shall be obtained and submitted to the drug regulatory department under the State Council for examination and approval Clinical trials of vaccines shall be conducted or organized by tertiary medical institutions or disease prevention and control institutions at or above the provincial level that meet the requirements prescribed by the drug regulatory department under the State Council and the health administrative department under the State Council Medical institutions and disease prevention and control institutions meeting the prescribed conditions shall actively participate in the clinical trials of vaccines Article 16 [protection of clinical trial subjects] the sponsor of a vaccine clinical trial shall formulate a clinical trial plan, establish a safety monitoring and evaluation system for clinical trials, and formulate detailed subject protection measures according to the risks Infants and children shall not be taken as subjects in vaccine clinical trials If infants and children really need to be taken as subjects in the development of infant vaccine, the subjects shall be selected from adults, carefully selected, and the subjects and age groups shall be reasonably set up The clinical trial must obtain the written informed consent of the subject or his guardian If the subject is a person with limited capacity for civil conduct, the written informed consent of the subject and his guardian shall be obtained Article 17 [conditional approval] in response to major public health events or vaccines that are urgently needed as determined by the health administration department under the State Council and are acceptable in risk and benefit assessment, the drug regulatory department under the State Council may grant conditional approval Article 18 [emergency authorization] in the event of a particularly serious public health emergency or other serious threat to public health and safety, if the health administration department under the State Council proposes to use the unapproved vaccine in an emergency, and the drug regulatory department under the State Council organizes experts to demonstrate that it may benefit, it may decide to use the unapproved vaccine within a certain range and time limit Miao If the emergency response is completed or the vaccine is proved to be invalid or has major safety risks in the process of emergency use, the drug regulatory department under the State Council shall terminate the authorization for emergency use of the vaccine in a timely manner Article 19 the drug regulatory department under the State Council shall, when approving the vaccine marketing license, approve the production process and quality control standards of the vaccine The instructions and labels of vaccines shall be approved by the drug regulatory department under the State Council The drug regulatory department under the State Council shall publish the instructions and labels of vaccines on its website in a timely manner The vaccine marketing license holder shall continuously update the instructions according to the post marketing research and abnormal reaction of vaccines Chapter III vaccine production and batch issuance Article 20 [strict access to production] the State implements a strict access system for vaccine manufacturers than for general drug manufacturers To engage in vaccine production activities, approval shall be obtained from the drug regulatory departments of provinces, autonomous regions and municipalities directly under the central government Article 21 [vaccine production license system] to engage in vaccine production activities, in addition to the conditions for general drug production, the following conditions shall also be met: (1) in line with the development plan of vaccine industry; (2) with appropriate scale and sufficient capacity reserve; (3) with systems and facilities to ensure biological safety; （4） Meet the needs of national disease prevention and control Qualification examination shall be carried out for key personnel of vaccine production enterprises The legal representative and the main person in charge shall have a good credit record; the production management shall be responsible for