Announcement of the State Administration for Market Regulation on Seeking Public Comments on the Law of the People's Republic of China on Vaccine Management (Draft for Comment)

Announcement of the State Administration for Market Regulation on Seeking Public Comments on the Law of the People's Republic of China on Vaccine Management (Draft for Comment)

November 11, 2018

The State Administration for Market Regulation, the National Medical Products Administration, the National Health Commission and other departments jointly drafted the vaccine management law in order to protect public health, promote public hygiene, safeguard national security and, according to the decisions of the Party Central Committee and the State Council, implement the legislative requirements of the Standing Committee of the National People's Congress.

It is hereby announced the Law of the People's Republic of China on Vaccine Management (Draft for Comment), as well as relevant explanations, drafted by the National Medical Products Administration and the National Health Commission and other departments. The public may submit their comments by the following means and methods:

1. Submitting comments and proposals by email to FGS@saic.gov.cn.

2. Submitting comments and proposals in writing to: Department of Regulations of the State Administration for Market Regulation, No. 8 Sanlihe East Road, Xicheng District, Beijing (100820), indicating such words on the envelope as "Comments on the Law of the People's Republic of China on Vaccine Management (Draft for Comment)".

The deadline for submission of comments is November 25, 2018.

Law of the People's Republic of China on Vaccine Management (Draft for Comment)

Chapter I General Provisions

Article 1 [Legislative Purpose] The Law is formulated in order to ensure vaccine safety, effectiveness and availability, regulate vaccination, protect and promote public health, and safeguard national security.

Article 2 [Scope of Application] Research, development, production, distribution and vaccination of vaccines, and supervision and management thereof, within the territory of the People's Republic of China shall conform to the Law.
For the purpose of the Law, "Vaccine" refers to the biological products for prevention used for human immunization vaccination in order to prevent and control the occurrence and prevalence of diseases. Vaccines are divided into immunization program vaccines and non-immunization program vaccines.

Article 3 [Principles of Management] Vaccine management shall be subject to the strictest supervision according to ethical, scientific and legal requirements and on the principles of risk management, overall control, scientific supervision and social governance.

Article 4 [Systems of Vaccination and Immunization Program] The state shall adopt the planned vaccination system and implement the expanded program on immunization.

Article 5 [Industrial Policies] The state shall insist on the strategic and public welfare nature of vaccines to formulate the development planning and industrial policies of the vaccine industry, expand financial investment and implement preferential tax policies to support basic research and application research, guide industrial structure optimization and formulate the pricing mechanism in line with industrial development to promote the research, development and innovation of vaccines. The state shall include in national strategies and grant priority support to the research and development of vaccines for prevention of major diseases.
The state shall implement strict access management of vaccine producers, guide and encourage vaccine producers to realize scale and intensive development and support vaccine producers to improve production process of vaccines in order to constantly improve the vaccine quality.

Article 6 [Marketing Authorization Holder System] The marketing authorization holder system shall be implemented upon vaccines. The vaccine marketing authorization holders shall be those drug producers that are capable of producing vaccines. The vaccine marketing authorization holders shall be legally responsible for the safety, effectiveness and quality control of vaccine research, development, production and distribution.
Whoever is engaged in vaccine research, development, production, distribution and vaccination shall abide by laws, regulations, standards and criteria, ensure the whole-process data are true, accurate, complete and traceable, assume the principal liability and accept supervision from the society.

Article 7 [Division of Duties] The department of drug supervision and administration under the State Council shall be responsible for supervising and administrating vaccine safety all over the country, formulating and supervising the implementation of standards and criteria, and assuming supervision and administration of vaccine research, development and marketing authorization, and lot release administration of vaccines. The health administrative department under the State Council shall be in charge of vaccination supervision and administration all over the country. The department of science and technology under the State Council shall be in charge of administration of biological safety with respect to vaccine research, development and production. The department of industry and information under the State Council shall be in charge of administration of the vaccine industry and formulation of development planning and industrial policies of the vaccine industry. Other relevant departments of the State Council shall handle work related to vaccine supervision and administration to the extent of their respective duties.
The departments of drug supervision and administration at the level of province, autonomous region or municipality directly under the Central Government shall implement the supervision and administration of the vaccine production activities within their respective administrative regions, supervise and guide the supervision and management of vaccine quality during vaccine distribution and vaccination. The departments of drug supervision and administration at the levels of city with districts and county shall be responsible for quality inspection and punishment during vaccine use within their respective administrative regions. The health administrative departments at or above the county level shall be responsible for supervision and administration of vaccination and relevant storage and transportation within their respective administrative regions.

Article 8 [Vaccine Coordination Mechanism] The State Council shall establish a multisectoral coordination mechanism of vaccine management, formulate major policies on vaccine industry layout, industrial planning, production, distribution, quality, safety, supply and reserve, vaccination, compensation and indemnification, etc., regularly analyze the vaccine safety situations, and push forward supervision and administration of vaccine safety.

Article 9 [Responsibilities of Local Governments] The people's governments at or above the county level shall be responsible for supervision and administration of vaccine safety within their respective administrative regions, lead, organize and coordinate in a unified manner the supervision and administration of vaccine safety and the response to vaccine safety emergencies within their respective administrative regions, establish and improve the mechanism of vaccine safety supervision and administration and the information sharing mechanism for vaccine safety, include vaccine safety in the plan for national economic and social development at the corresponding levels, list vaccine safety work funds in their financial budgets and strengthen the building of supervision and administration capacity of vaccine safety in order to provide safeguards for vaccine safety.
The people's governments of provinces, autonomous regions or municipalities directly under the Central Government shall establish the coordination mechanism of vaccine management, implement strict safety management of vaccine production, distribution and vaccination, and regularly analyze vaccine safety situations.

Article 10 [Traceability System] The whole-course vaccine information traceability system shall be implemented nationwide.
The drug administrative department under the State Council shall, together with the health administrative department under the State Council, formulate unified vaccine traceability standards and criteria, establish a nationwide electronic traceability coordination platform, integrate whole-course traceability information from production, distribution to use, in order to ensure the traceability of vaccine quality and safety.
The vaccine marketing authorization holders shall establish a vaccine information traceability system to ensure traceability and inspection of the whole course of production, storage, transportation and use of the minimum packing unit of vaccine products for a long period. Disease prevention and control agencies and vaccination agencies shall legally and faithfully record the information about vaccine distribution and use, and provide traceability information according to standards.

Article 11 [Popular Science Popularization] The people's governments at all levels shall strengthen vaccine safety publicity and education, and disseminate the laws and regulations on vaccine safety, the vaccine safety standards and the vaccination knowledge.
News media shall carry out public welfare publicity of pertinent vaccine laws, regulations and standards, as well as vaccination knowledge, conduct media supervision against illegal acts relating to vaccines. Media reports on vaccines shall be scientific, objective and impartial.

Article 12 [Social Governance] Vaccine industrial organizations shall enhance industry self-discipline, establish sound industrial standards, push forward the building of industrial credit system, guide and urge enterprises to carry out production and operation activities in accordance with the law, and promote the vaccine industry to realize self-management, self-regulation, self-purification and self-improvement.
Social third-person institutions shall be encouraged to provide technical consultation and compliance guidance services to vaccine marketing authorization holders.
Organizations and individuals that make significant contributions to vaccine creation, disease prevention and control, supervision and administration shall be awarded and rewarded according to pertinent state regulations.
Any organization or individual shall have the right to report on illegal acts relating to vaccines, legally inquire about vaccine information from relevant departments, and put forward opinions and suggestions with respect to vaccine supervision and administration.

Chapter II Vaccine Research & Development and Marketing Authorization

Article 13 [Marketing Authorization System] Before marketing of a vaccine product, the approval of the drug administrative department under the State Council and the certification of drug marketing authorization shall be secured.
Whoever applies for vaccine marketing authorization shall submit sufficient and credible research data and materials.

Article 14 [Biological Safety and Bacterial Strain & Cell Management] Vaccine research & development entities and marketing authorization holders shall strictly control biological safety risks, strengthen biological safety management of bacterial strains and other pathogenic microorganisms, protect the health of operators and the public, and ensure the bacterial strains are to be used for proper purposes.
As for bacterial strains and cell lines for vaccine research, development, production and inspection, such information as history, biological characters and generation shall be clear, and detailed archives shall be set up to ensure their sources are distinct and traceable.

Article 15 [Approval of Clinical Trial and Organization Management] Whoever carries out vaccine clinical trials must obtain the consent of the Ethics Committee through examination and report to the department of drug supervision and administration under the State Council for examination and approval.
Vaccine clinical trials shall be implemented or organized by the third-grade medical institutions or the disease prevention and control institutions at or above the provincial level that meet the requirements set forth by the department of drug supervision and administration and the health administrative department under the State Council.
Those medical institutions and disease prevention and control institutions that meet the requirements shall take an active part in vaccine clinical trials.

Article 16 [Protection of Clinical Trial Testees] An applicant for vaccine clinical trial shall formulate the clinical trial plan, establish the safety monitoring and evaluation system for clinical trial, and work out detailed testee protection measures according to specific risks.
No infants may be accepted as testees of any vaccine clinical trial. Where it is necessary to choose infants as testees for the purpose of research and development of infant vaccines, the testee group shall be selected from adults, testees shall be selected cautiously, and the testee groups and age groups shall be set up in a reasonable way.
Whoever conducts clinical trials must receive the written informed consent forms from testees or their custodians. Where a testee is a person with limited capacity for civil conduct, the written informed consent form issued by the testee and his custodian shall be secured.

Article 17 [Conditional Approval] The department of drug supervision and administration under the State Council may make a conditional approval with respect to the vaccines which are necessary to deal with a major public health event or are identified as urgent needs by the health administrative department under the State Council, and of which the result of risk-profit evaluation is acceptable.

Article 18 [Emergency Authorization] In case of extremely major emergency public health events or other emergencies which seriously threaten public health and safety, and if the health administrative department under the State Council puts forward a proposal on emergency use of unapproved vaccines, and the department of drug supervision and administration under the State Council deems through expert argumentation that it may benefit, the vaccines of which marketing has not been approved may be decided to use within a certain scope and period.
Upon termination of emergency response, or once it is proved during emergency use that a vaccine is invalid or contains serious safety risks, the department of drug supervision and administration under the State Council shall promptly terminate the authorization of emergency use of the vaccine.

Article 19 [Registration Standards and Approval of Instructions and Labels] Before approving a vaccine marketing authorization, the department of drug supervision and administration under the State Council shall approve the production process and quality control standard of the vaccine.
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