Vaccine Administration Law of the People's Republic of China
Vaccine Administration Law of the People's Republic of China
Vaccine Administration Law of the People's Republic of China
Order of the President of the People's Republic of China No. 30
June 29, 2019
The Vaccine Administration Law of the People's Republic of China, which was adopted at the 11th Session of the Standing Committee of the 13th National People's Congress of the People's Republic of the China on June 29, 2019, is hereby promulgated and shall come into effect as of December 1, 2019.
Xi Jinping, President of the People's Republic of China
Vaccine Administration Law of the People's Republic of China
(Adopted at the 11th Session of the Standing Committee of the 13th National People's Congress on June 29, 2019)
Contents
Chapter I General Provisions
Chapter II Vaccine Development and Registration
Chapter III Vaccine Production and Lot Release
Chapter IV Vaccine Distribution
Chapter V Vaccination
Chapter VI Abnormal Reaction Monitoring and Processing
Chapter VII Post-marketing Vaccine Management
Chapter VIII Safeguard Measures
Chapter IX Supervision and Management
Chapter X Legal Liability
Chapter XI Supplementary Provisions
Chapter I General Provisions
Article 1 This Law is formulated with a view to enhance vaccine administration, ensuring vaccine quality and supply, regulating vaccination, promoting the development of the vaccine industry, safeguarding public health and maintaining public health security.
Article 2 This Law shall apply to those who engage in such activities as vaccine development, production, distribution and vaccination, as well as the supervision and management thereof within the territory of the People's Republic of China. Matters concerned not provided herein shall be subject to the Drug Administration Law of the People's Republic of China, the Law of the People's Republic of China on the Prevention and Control of Infectious Diseases as well as other laws and administrative regulations.
For the purpose of this Law, "vaccine" refers to any preventive biological product used for vaccination-based human immunization with a view to preventing and controlling the occurrence and epidemic of diseases, including immunization program vaccines and non-immunization program vaccines.
Article 3 The State implements the most stringent management system for vaccines, and adheres to the principles of safety first, risk management, whole-process management and control, scientific supervision and social co-governance.
Article 4 The State adheres to the strategic and public welfare nature of vaccine products.
The State supports basic research and application research of vaccines, promotes the development and innovation of vaccines, and incorporates the development, production and reserve of vaccines for the prevention and control of major diseases into national strategies.
The State will formulate development plans and industrial policies for and support the development and structural optimization of the vaccine industry and encourage large-scale and intensive production of vaccines so as to continuously improve the production process and quality level of vaccines.
Article 5 Vaccine marketing authorization holders shall strengthen the whole-lifecycle quality management of vaccines and be responsible for the safety, efficacy, and quality controllability of vaccines.
Entities and individuals engaging in vaccine development, production, distribution or vaccination shall abide by laws, regulations, rules, standards and practices, ensure the authenticity, accuracy, completeness and traceability of information throughout the whole course, assume relevant responsibility in accordance with the law and accept societal supervision.
Article 6 The State implements an immunization program system.
Residents living within the territory of the People's Republic of China shall have the right and perform the obligation to be vaccinated with immunization program vaccines in accordance with the law. The government will provide immunization program vaccines for residents free of charge.
People's governments at or above the county level and pertinent developments thereunder shall guarantee that eligible children will be vaccinated with immunization program vaccines, and guardians shall ensure that their eligible children are vaccinated with immunization program vaccines on schedule in accordance with the law.
Article 7 People's governments at or above the county level shall incorporate vaccine safety and vaccination into their national economic and social development plans at the corresponding levels, strengthen the construction of vaccine supervision and management capabilities, and establish a sound working mechanism for the supervision and management of vaccines.
Local people's governments at or above the county level shall be responsible for as well as lead, organize and coordinate in a unified manner the supervision and management of vaccines within their respective administrative regions.
Article 8 The medical products administration under the State Council shall be responsible for the supervision and management of vaccines nationwide. The health administration under the State Council shall be responsible for the supervision and management of vaccinations nationwide. Other pertinent developments under the State Council shall be responsible for vaccine-related supervision and management within the scope of their respective duties.
Medical products administrations under people's governments of all provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the supervision and management of vaccines within their respective administrative regions. Administrations undertaking the duties for drug supervision and management (hereinafter referred to as "medical products administrations") under people's governments of cities with subordinate districts or counties shall be responsible for the supervision and management of vaccines within their respective administrative regions. Health administrations under local people's governments at or above the county level shall be responsible for the supervision and management of vaccinations within their respective administrative regions. Other pertinent developments under local people's governments at or above the county level shall be responsible for vaccine-related supervision and management within the scope of their respective duties.
Article 9 The State Council, people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall establish a departmental coordination mechanism, carry out overall coordination of relevant work concerning the supervision and management of vaccines, analyze the vaccine safety situation on a regular basis, strengthen the supervision and management of vaccines and guarantee the supply of vaccines.
Article 10 The State implements a whole-course vaccine e-traceability system.
The medical products administration under the State Council shall, in collaboration with the health administration under the State Council, formulate unified vaccine traceability standards and practices, establish a national vaccine e-traceability collaboration platform, and integrate whole-course traceability information throughout the vaccine production, distribution and vaccination, so as to achieve the traceability of vaccines.
Vaccine marketing authorization holders shall establish a vaccine e-traceability system to be linked up with the national vaccine e-traceability collaboration platform, so as to achieve the whole-course traceability and verifiability of vaccines in the minimum packaging unit throughout the production, distribution and vaccination.
Disease prevention and control institutions and vaccination units shall legally and faithfully record the information on vaccine distribution and vaccination, etc., and provide relevant traceability information for the national vaccine e-traceability collaboration platform as required.
Article 11 It is required to establish a sound bio-safety management system in the courses of vaccine development, production and testing, etc., strictly control bio-safety risks, strengthen the bio-safety management of pathogenic microorganisms such as bacterial strains, protect the health of operators and the public, and ensure that pathogenic microorganisms such as bacterial strains are used for legal and proper purposes.
With respect to bacterial strains and cell lines used for vaccine development, production and testing, etc., it is required to specify the histories, biological characteristics and generations thereof and establish detailed files so as to ensure the legality, clarity and traceability of their sources; none of those without clear sources may be used.
Article 12 People's governments at all levels and pertinent developments thereunder, disease prevention and control institutions, vaccination units, vaccine marketing authorization holders and vaccine industry associations, etc., shall, by virtue of activities such as the National Children's Vaccination Day, carry out publicity and popularization of and education on vaccine safety-related laws and regulations as well as vaccination knowledge, etc., on a regular basis.
News media shall carry out public welfare publicity of vaccine safety-related laws and regulations as well as vaccination knowledge, etc., and conduct media supervision against vaccine-related illegal acts. Vaccine-related publicity and reporting shall be carried out in a complete, scientific, objective and impartial manner.
Article 13 Vaccine industry associations shall enhance their industry self-discipline, establish sound industry practices, push forward the building of an industry credit system, and guide and impel their members to carry out production and business activities, etc. in accordance with the law.
Chapter II Vaccine Development and Registration
Article 14 The State shall, in light of such factors as the disease epidemic situation and population immunization status, formulate relevant development plans and arrange necessary funds to support the development of new-type mixed and multivalent vaccines, etc.
The State shall organize vaccine marketing authorization holders, scientific research units, medical and health institutions to jointly tackle key problems and develop vaccines urgently needed for disease prevention and control.
Article 15 The State encourages vaccine marketing authorization holders to increase fund investment in development and innovation, optimize production processes, improve the quality control level and promote vaccine technology advancement.
Article 16 Whoever conducts a vaccine clinical trial shall obtain the approval of the medical products administration under the State Council in accordance with the law.
Vaccine clinical trials shall be implemented or organized for implementation by Grade-III medical institutions or disease prevention and control institutions at or above the provincial level that meet the requirements prescribed by the medical products administration and the health administration under the State Council.
The State encourages qualified medical institutions and disease prevention and control institutions, etc., to carry out vaccine clinical trials in accordance with the law.
Article 17 Whoever applies to conduct a vaccine clinical trial shall develop a clinical trial scheme, establish a clinical trial safety monitoring and evaluation system, prudently select subjects, set up subject groups and age groups in a reasonable manner, and take effective measures in light of the risk degree to protect subjects' legitimate rights and interests.
Article 18 Whoever conducts a vaccine clinical trial shall obtain subjects' informed consent in writing; with respect to subjects without capacity for civil conduct, their guardians' informed consent in writing shall be obtained; and with respect to subjects with limited capacity for civil conduct, both such subjects and their guardians' informed consent in writing shall be obtained.
Article 19 Whoever markets any vaccine within the territory of China shall obtain a drug registration certificate upon approval of the medical products administration under the State Council; and whoever applies for vaccine registration shall provide authentic, adequate and reliable data, materials and samples concerned.
With respect to vaccines urgently needed for disease prevention and control or innovative vaccines, the medical products administration under the State Council shall give priority to the evaluation and approval thereof.
Article 20 With respect to vaccines urgently needed for the purpose of dealing with major public health emergency incidents or other vaccines identified as urgently needed by the health administration under the State Council, in the case of more benefits than risks therein found upon evaluation, the medical products administration under the State Council shall grant conditional approval of the application for registration thereof.
In the case of any major public health emergency incident or other emergency incident that seriously threatens public health, the health administration under the State Council may, in light of the need for infectious disease prevention and control, put forward a proposal on the urgent use of the relevant vaccine, which may be carried out within a certain scope and time limit with the consent of the medical products administration under the State Council through organizing pertinent argumentation.
Article 21 The medical products administration under the State Council shall, when approving an application for vaccine registration, verify the vaccine production process, quality control standards, instructions and labels.
The medical products administration under the State Council shall promptly announce the contents of vaccine instructions and labels on its website.
Chapter III Vaccine Production and Lot Release
Article 22 The State implements a strict access system for vaccine production.
Whoever engages in vaccine production activities shall obtain a drug production license upon approval of the competent medical products administration under the relevant people's government at or above the provincial level.
Whoever engages in vaccine production activities shall meet the following conditions in addition to those specified in the Drug Administration Law of the People's Republic of China on engaging in drug production activities:
1. it has a moderate scale and adequate production capacity reserves;
2. it has bio-safety assurance systems, facilities and devices; and
3. it meets the need for disease prevention and control.
A vaccine marketing authorization holder shall have vaccine production capacity; where sub-contract production is definitely necessary due to its inadequate vaccine production capacity, it shall obtain the approval of the medical products administration under the State Council. Whoever accepts the sub-contract production shall abide by this Law and relevant regulations of the State to ensure the vaccine quality.
Article 23 The legal representative and main principal of a vaccine marketing authorization holder shall have a good credit record, and personnel in key positions such as the head of production management and that of quality management as well as quality authorized personnel shall respectively have the pertinent professional background and work experience.
Vaccine marketing authorization holders shall strengthen the training and assessment of the personnel specified in the preceding paragraph, and promptly report the situation concerning any appointment and change thereof to competent medical products administrations under people's governments of provinces, autonomous regions or municipalities directly under the Central Government.
Article 24 Vaccines shall be produced and tested in line with approved production processes and quality control standards. The whole course of production shall conform to the requirements of the Good Manufacturing Practices.
Vaccine marketing authorization holders shall examine and verify as well as inspect the whole course of vaccine production and vaccine quality as required.
Article 25 Vaccine marketing authorization holders shall establish a complete production and quality management system, constantly strengthen the deviation management and faithfully record all data generated in production and inspection by means of information, so as to ensure continuous compliance with the relevant statutory requirements throughout the production.
Article 26 The State implements a vaccine lot release system.
Prior to being marketed or imported, each batch of vaccines shall be subject to the examination and verification as well as testing by the lot release institution designated by the medical products administration under the State Council in line with relevant technical requirements. Those meeting the relevant requirements shall be granted a lot release certificate; otherwise, a notice of disapproval for lot release shall be issued.
Vaccines subject to disapproval for lot release may not be marketed for sale, but shall be destroyed under the supervision of competent medical products administrations under people's governments of provinces, autonomous regions or municipalities directly under the Central Government; imported vaccines subject to disapproval for lot release shall be destroyed or otherwise legally disposed of under the supervision of competent medical products administrations of places where the pertinent ports are located.
The medical products administration under the State Council and pertinent lot release institution shall promptly announce the lot release results of marketed vaccines for public inquiry.
Article 27 Whoever applies for vaccine lot release shall, as required, provide materials including a summary of lot production and testing records along with samples such as products with the same lot number for the pertinent lot release institution.
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Order of the President of the People's Republic of China No. 30
June 29, 2019
The Vaccine Administration Law of the People's Republic of China, which was adopted at the 11th Session of the Standing Committee of the 13th National People's Congress of the People's Republic of the China on June 29, 2019, is hereby promulgated and shall come into effect as of December 1, 2019.
Xi Jinping, President of the People's Republic of China
Vaccine Administration Law of the People's Republic of China
(Adopted at the 11th Session of the Standing Committee of the 13th National People's Congress on June 29, 2019)
Contents
Chapter I General Provisions
Chapter II Vaccine Development and Registration
Chapter III Vaccine Production and Lot Release
Chapter IV Vaccine Distribution
Chapter V Vaccination
Chapter VI Abnormal Reaction Monitoring and Processing
Chapter VII Post-marketing Vaccine Management
Chapter VIII Safeguard Measures
Chapter IX Supervision and Management
Chapter X Legal Liability
Chapter XI Supplementary Provisions
Chapter I General Provisions
Article 1 This Law is formulated with a view to enhance vaccine administration, ensuring vaccine quality and supply, regulating vaccination, promoting the development of the vaccine industry, safeguarding public health and maintaining public health security.
Article 2 This Law shall apply to those who engage in such activities as vaccine development, production, distribution and vaccination, as well as the supervision and management thereof within the territory of the People's Republic of China. Matters concerned not provided herein shall be subject to the Drug Administration Law of the People's Republic of China, the Law of the People's Republic of China on the Prevention and Control of Infectious Diseases as well as other laws and administrative regulations.
For the purpose of this Law, "vaccine" refers to any preventive biological product used for vaccination-based human immunization with a view to preventing and controlling the occurrence and epidemic of diseases, including immunization program vaccines and non-immunization program vaccines.
Article 3 The State implements the most stringent management system for vaccines, and adheres to the principles of safety first, risk management, whole-process management and control, scientific supervision and social co-governance.
Article 4 The State adheres to the strategic and public welfare nature of vaccine products.
The State supports basic research and application research of vaccines, promotes the development and innovation of vaccines, and incorporates the development, production and reserve of vaccines for the prevention and control of major diseases into national strategies.
The State will formulate development plans and industrial policies for and support the development and structural optimization of the vaccine industry and encourage large-scale and intensive production of vaccines so as to continuously improve the production process and quality level of vaccines.
Article 5 Vaccine marketing authorization holders shall strengthen the whole-lifecycle quality management of vaccines and be responsible for the safety, efficacy, and quality controllability of vaccines.
Entities and individuals engaging in vaccine development, production, distribution or vaccination shall abide by laws, regulations, rules, standards and practices, ensure the authenticity, accuracy, completeness and traceability of information throughout the whole course, assume relevant responsibility in accordance with the law and accept societal supervision.
Article 6 The State implements an immunization program system.
Residents living within the territory of the People's Republic of China shall have the right and perform the obligation to be vaccinated with immunization program vaccines in accordance with the law. The government will provide immunization program vaccines for residents free of charge.
People's governments at or above the county level and pertinent developments thereunder shall guarantee that eligible children will be vaccinated with immunization program vaccines, and guardians shall ensure that their eligible children are vaccinated with immunization program vaccines on schedule in accordance with the law.
Article 7 People's governments at or above the county level shall incorporate vaccine safety and vaccination into their national economic and social development plans at the corresponding levels, strengthen the construction of vaccine supervision and management capabilities, and establish a sound working mechanism for the supervision and management of vaccines.
Local people's governments at or above the county level shall be responsible for as well as lead, organize and coordinate in a unified manner the supervision and management of vaccines within their respective administrative regions.
Article 8 The medical products administration under the State Council shall be responsible for the supervision and management of vaccines nationwide. The health administration under the State Council shall be responsible for the supervision and management of vaccinations nationwide. Other pertinent developments under the State Council shall be responsible for vaccine-related supervision and management within the scope of their respective duties.
Medical products administrations under people's governments of all provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the supervision and management of vaccines within their respective administrative regions. Administrations undertaking the duties for drug supervision and management (hereinafter referred to as "medical products administrations") under people's governments of cities with subordinate districts or counties shall be responsible for the supervision and management of vaccines within their respective administrative regions. Health administrations under local people's governments at or above the county level shall be responsible for the supervision and management of vaccinations within their respective administrative regions. Other pertinent developments under local people's governments at or above the county level shall be responsible for vaccine-related supervision and management within the scope of their respective duties.
Article 9 The State Council, people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall establish a departmental coordination mechanism, carry out overall coordination of relevant work concerning the supervision and management of vaccines, analyze the vaccine safety situation on a regular basis, strengthen the supervision and management of vaccines and guarantee the supply of vaccines.
Article 10 The State implements a whole-course vaccine e-traceability system.
The medical products administration under the State Council shall, in collaboration with the health administration under the State Council, formulate unified vaccine traceability standards and practices, establish a national vaccine e-traceability collaboration platform, and integrate whole-course traceability information throughout the vaccine production, distribution and vaccination, so as to achieve the traceability of vaccines.
Vaccine marketing authorization holders shall establish a vaccine e-traceability system to be linked up with the national vaccine e-traceability collaboration platform, so as to achieve the whole-course traceability and verifiability of vaccines in the minimum packaging unit throughout the production, distribution and vaccination.
Disease prevention and control institutions and vaccination units shall legally and faithfully record the information on vaccine distribution and vaccination, etc., and provide relevant traceability information for the national vaccine e-traceability collaboration platform as required.
Article 11 It is required to establish a sound bio-safety management system in the courses of vaccine development, production and testing, etc., strictly control bio-safety risks, strengthen the bio-safety management of pathogenic microorganisms such as bacterial strains, protect the health of operators and the public, and ensure that pathogenic microorganisms such as bacterial strains are used for legal and proper purposes.
With respect to bacterial strains and cell lines used for vaccine development, production and testing, etc., it is required to specify the histories, biological characteristics and generations thereof and establish detailed files so as to ensure the legality, clarity and traceability of their sources; none of those without clear sources may be used.
Article 12 People's governments at all levels and pertinent developments thereunder, disease prevention and control institutions, vaccination units, vaccine marketing authorization holders and vaccine industry associations, etc., shall, by virtue of activities such as the National Children's Vaccination Day, carry out publicity and popularization of and education on vaccine safety-related laws and regulations as well as vaccination knowledge, etc., on a regular basis.
News media shall carry out public welfare publicity of vaccine safety-related laws and regulations as well as vaccination knowledge, etc., and conduct media supervision against vaccine-related illegal acts. Vaccine-related publicity and reporting shall be carried out in a complete, scientific, objective and impartial manner.
Article 13 Vaccine industry associations shall enhance their industry self-discipline, establish sound industry practices, push forward the building of an industry credit system, and guide and impel their members to carry out production and business activities, etc. in accordance with the law.
Chapter II Vaccine Development and Registration
Article 14 The State shall, in light of such factors as the disease epidemic situation and population immunization status, formulate relevant development plans and arrange necessary funds to support the development of new-type mixed and multivalent vaccines, etc.
The State shall organize vaccine marketing authorization holders, scientific research units, medical and health institutions to jointly tackle key problems and develop vaccines urgently needed for disease prevention and control.
Article 15 The State encourages vaccine marketing authorization holders to increase fund investment in development and innovation, optimize production processes, improve the quality control level and promote vaccine technology advancement.
Article 16 Whoever conducts a vaccine clinical trial shall obtain the approval of the medical products administration under the State Council in accordance with the law.
Vaccine clinical trials shall be implemented or organized for implementation by Grade-III medical institutions or disease prevention and control institutions at or above the provincial level that meet the requirements prescribed by the medical products administration and the health administration under the State Council.
The State encourages qualified medical institutions and disease prevention and control institutions, etc., to carry out vaccine clinical trials in accordance with the law.
Article 17 Whoever applies to conduct a vaccine clinical trial shall develop a clinical trial scheme, establish a clinical trial safety monitoring and evaluation system, prudently select subjects, set up subject groups and age groups in a reasonable manner, and take effective measures in light of the risk degree to protect subjects' legitimate rights and interests.
Article 18 Whoever conducts a vaccine clinical trial shall obtain subjects' informed consent in writing; with respect to subjects without capacity for civil conduct, their guardians' informed consent in writing shall be obtained; and with respect to subjects with limited capacity for civil conduct, both such subjects and their guardians' informed consent in writing shall be obtained.
Article 19 Whoever markets any vaccine within the territory of China shall obtain a drug registration certificate upon approval of the medical products administration under the State Council; and whoever applies for vaccine registration shall provide authentic, adequate and reliable data, materials and samples concerned.
With respect to vaccines urgently needed for disease prevention and control or innovative vaccines, the medical products administration under the State Council shall give priority to the evaluation and approval thereof.
Article 20 With respect to vaccines urgently needed for the purpose of dealing with major public health emergency incidents or other vaccines identified as urgently needed by the health administration under the State Council, in the case of more benefits than risks therein found upon evaluation, the medical products administration under the State Council shall grant conditional approval of the application for registration thereof.
In the case of any major public health emergency incident or other emergency incident that seriously threatens public health, the health administration under the State Council may, in light of the need for infectious disease prevention and control, put forward a proposal on the urgent use of the relevant vaccine, which may be carried out within a certain scope and time limit with the consent of the medical products administration under the State Council through organizing pertinent argumentation.
Article 21 The medical products administration under the State Council shall, when approving an application for vaccine registration, verify the vaccine production process, quality control standards, instructions and labels.
The medical products administration under the State Council shall promptly announce the contents of vaccine instructions and labels on its website.
Chapter III Vaccine Production and Lot Release
Article 22 The State implements a strict access system for vaccine production.
Whoever engages in vaccine production activities shall obtain a drug production license upon approval of the competent medical products administration under the relevant people's government at or above the provincial level.
Whoever engages in vaccine production activities shall meet the following conditions in addition to those specified in the Drug Administration Law of the People's Republic of China on engaging in drug production activities:
1. it has a moderate scale and adequate production capacity reserves;
2. it has bio-safety assurance systems, facilities and devices; and
3. it meets the need for disease prevention and control.
A vaccine marketing authorization holder shall have vaccine production capacity; where sub-contract production is definitely necessary due to its inadequate vaccine production capacity, it shall obtain the approval of the medical products administration under the State Council. Whoever accepts the sub-contract production shall abide by this Law and relevant regulations of the State to ensure the vaccine quality.
Article 23 The legal representative and main principal of a vaccine marketing authorization holder shall have a good credit record, and personnel in key positions such as the head of production management and that of quality management as well as quality authorized personnel shall respectively have the pertinent professional background and work experience.
Vaccine marketing authorization holders shall strengthen the training and assessment of the personnel specified in the preceding paragraph, and promptly report the situation concerning any appointment and change thereof to competent medical products administrations under people's governments of provinces, autonomous regions or municipalities directly under the Central Government.
Article 24 Vaccines shall be produced and tested in line with approved production processes and quality control standards. The whole course of production shall conform to the requirements of the Good Manufacturing Practices.
Vaccine marketing authorization holders shall examine and verify as well as inspect the whole course of vaccine production and vaccine quality as required.
Article 25 Vaccine marketing authorization holders shall establish a complete production and quality management system, constantly strengthen the deviation management and faithfully record all data generated in production and inspection by means of information, so as to ensure continuous compliance with the relevant statutory requirements throughout the production.
Article 26 The State implements a vaccine lot release system.
Prior to being marketed or imported, each batch of vaccines shall be subject to the examination and verification as well as testing by the lot release institution designated by the medical products administration under the State Council in line with relevant technical requirements. Those meeting the relevant requirements shall be granted a lot release certificate; otherwise, a notice of disapproval for lot release shall be issued.
Vaccines subject to disapproval for lot release may not be marketed for sale, but shall be destroyed under the supervision of competent medical products administrations under people's governments of provinces, autonomous regions or municipalities directly under the Central Government; imported vaccines subject to disapproval for lot release shall be destroyed or otherwise legally disposed of under the supervision of competent medical products administrations of places where the pertinent ports are located.
The medical products administration under the State Council and pertinent lot release institution shall promptly announce the lot release results of marketed vaccines for public inquiry.
Article 27 Whoever applies for vaccine lot release shall, as required, provide materials including a summary of lot production and testing records along with samples such as products with the same lot number for the pertinent lot release institution.
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