Order of the President of the People's Republic of China

No. 30 

The Vaccine Administration Law of the People's Republic of China, adopted at the 11th Meeting of the Standing Committee of the Thirteenth National People's Congress on June 29, 2019, is hereby promulgated and shall go into effect as of December 1, 2019. 

Xi Jinping 

President of the People's Republic of China 

June 29, 2019 

Vaccine Administration Law of the People's Republic of China

(Adopted at the 11th Meeting of the Standing Committee of the Thirteenth National People's Congress on June 29, 2019) 

Content 

Chapter I  General Provisions 

Chapter II Vaccine Development and Registration 

Chapter III Vaccine Manufacture and Lot Release 

Chapter IV Vaccine Distribution 

Chapter V Immunization 

Chapter VI Adverse Reactions Monitoring and Handling 

Chapter VII Vaccine Post-Marketing Management 

Chapter VIII Safeguard Measures 

Chapter IX Supervision and Management 

Chapter X Legal Liabilities 

Chapter XI Supplementary Provisions 

Chapter I

General Provisions  

Article 1 This Law is enacted to enhance the vaccine administration, to ensure the quality and supply of vaccines, to standardize the immunization, to promote the development of the vaccine industry,  and to safeguard public health and safety. 

Article 2 This Law shall govern activities involving vaccine development, manufacture, distribution, immunization and vaccine administration in the territory of the People's Republic of China. In cases of not being stipulated in this Law, those activities shall be governed by 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 and relevant laws and administrative regulations.

For the purpose of this Law, vaccines refer to the prophylactic biological products for human immunization to prevent the occurrence and prevent, if not to be prevented, the prevalence of diseases, including immunization program vaccines and non-immunization program vaccines.

Article 3 The State implements the most stringent regulatory system for vaccines and adheres to principles of safety first, risk management, whole process control, scientific supervision and social co-governance.

Article 4 The State maintains the strategic and public welfare nature of vaccine products. 

The State supports fundamental research and application research of vaccines, promotes development and innovation of vaccines and incorporates the development, manufacture and stockpile of vaccines for the prevention and control of major diseases into the national strategy. 

The State formulates development planning and industry policies for the vaccine industry to support development and structural optimization of the vaccine industry, and encourages scale and intensive production and constant improvement on the production process and quality of vaccines. 

Article 5 Vaccine marketing authorization holders (MAHs) shall enhance the vaccine life cycle quality management and be responsible for the safety, effectiveness and quality management of vaccines. 

All entities and individuals engaged in vaccine development, manufacture, distribution and immunization shall comply with laws, regulations, rules, standards and norms, ensure the authenticity, accuracy, integrity and traceability of information through the whole process, take responsibilities in accordance with law and accept social supervision. 

(Through the whole process of vaccine development, manufacture, distribution and immunization, in which any entity or/and individual engaged, shall comply with laws, regulations, rules, standards and norms, ensure the authenticity, accuracy, integrity and traceability of information, take responsibilities in accordance with law and accept social supervision.) 

Article 6 The State implements immunization program system. 

All citizens who reside in the territory of the People's Republic of China shall be entitled and obliged to be immunized with national immunization program vaccines according to law. The government shall provide immunization program vaccines for the citizens free of charge. 

People's governments and relevant departments at or above the county level shall ensure that children at proper age are immunized with immunization program vaccines. The guardians shall ensure that children at proper age are immunized with the immunization program vaccines on schedule according to law. 

Article 7 People's governments at or above the county level shall incorporate the vaccine safety, immunization work into the national economic and social development plans of the corresponding level, enhance the capacity building of vaccine administration, and establish and improve the work mechanism for vaccine administration. 

Local people's governments at or above the county level shall be responsible for vaccine administration within their administrative regions, as well as leading, organizing and coordinating vaccine administration within their respective administrative regions in a unified manner. 

Article 8 The drug regulatory department under the State Council shall be responsible for the administration of vaccines nationwide. The competent health department under the State Council shall be responsible for the administration of immunization nationwide. Other relevant departments under the State Council shall be responsible for the administration of vaccines within the scope of their respective responsibilities. 

Drug regulatory departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the vaccine administration within their respective administrative regions. Departments undertaking responsibilities for drug administration (hereinafter referred to as drug regulatory departments) of the people's governments of municipalities divided into districts and at county level shall undertake the administrative duties on vaccines within their respective administrative regions. The competent health departments of people's governments at or above the county level shall undertake the administration of immunization within their respective administrative regions. Other relevant departments of the people's governments at or above the county level shall undertake the administrative duties on vaccines within the scope of their respective responsibilities. 

Article 9 The State Council and people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall establish a coordination mechanism to comprehensively coordinate relevant work of vaccine administration, regularly analyze the safety situations of vaccines, enhance vaccine administration and ensure vaccine supply. 

Article 10 The State implements the whole process electronic traceability system for vaccines. 

The drug regulatory department under the State Council shall, in collaboration with the competent health department under the State Council, formulate unified vaccine traceability norms and standards, establish a national coordination platform for vaccine electronic traceability, and integrate traceability information of the whole process throughout manufacture, distribution and immunization to realize the traceability of vaccines. 

Vaccine MAHs shall establish the vaccine electronic traceability system, and connect it to the national coordination platform for vaccine electronic traceability, so as to enable the traceability and verification of the smallest package unit of vaccines through the whole process of manufacture, distribution and immunization. 

Disease prevention and control institutions and immunization entities shall truthfully record conditions including vaccine distribution and immunization in accordance with law, and provide traceability information to the national coordination platform for vaccine electronic traceability as required. 

Article 11 The biological safety management system shall be established and improved during vaccine development, manufacture and testing, to enable strict control of the biological safety risks, to enhance biological safety management of pathogenic microorganisms including bacterial and viral strains, to protect the health of operators and the public, and to ensure pathogenic microorganisms including bacterial and viral strains are used for legal and proper purposes. 

Bacterial and viral strains and cell strains used in the development, manufacturing and testing of vaccines shall have their track record, biological features and passage numbers specified, detailed archives established, to ensure legal, clear and traceable source; and those with unidentified source shall not be used. 

Article 12 People's governments at all levels and relevant departments, disease prevention and control institutions, immunization entities, vaccine MAHs and vaccine industry associations shall regularly carry out the publicity and education of laws and regulations of vaccines and knowledge of immunization in occasions such as national children's immunization day. 

News media shall, for the public welfare, carry out publicity on vaccine safety laws and regulations, and knowledge of immunization, and supervise illegal behaviors related to vaccines through public opinions. Publicity reports on vaccines shall be comprehensive, scientific, objective and impartial. 

Article 13 Vaccine industry associations shall enhance industry self-discipline, establish and improve industry norms, and promote the construction of industry integrity system, so as to guide and urge their member enterprises to manufacture and distribute vaccines in accordance with law. 

Chapter II

Vaccine Development and Registration

Article 14 The State formulates relevant development plans, arranges necessary funds and supports the development of innovative vaccines such as combined and/or polyvalent vaccines in response to factors such as the prevalence of diseases and population immunity. 

The State organizes vaccine MAHs, research institutions, medical and health institutions to work jointly to develop vaccines urgently needed for disease prevention and control.

Article 15 To facilitate the progress of vaccine technology, the State encourages vaccine MAHs to increase capital investment on research, development and innovation, to optimize production process, and to promote quality control level. 

Article 16 Conduct of vaccine clinical trials shall be approved by the drug regulatory department under the State Council in accordance with law. 

Vaccine clinical trials shall be carried out or organized by Class III 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 competent health department under the State Council. 

The State encourages eligible medical institutions and disease prevention and control institutions to conduct vaccine clinical trials in accordance with law. 

Article 17 The sponsor of vaccine clinical trials shall design the clinical trial protocol, establish the safety monitoring and evaluation system for clinical trials, prudently select subjects, appropriately set up subject population and age groups, and take effective measures based on risk levels to protect legal interests of subjects. 

Article 18 Written informed consent shall be obtained from subjects for vaccine clinical trials; where the subject is a person without capacity for civil conduct, the written informed consent shall be obtained from his/her guardian; where the subject is a person with limited capacity for civil conduct, the written informed consent shall be obtained from the subject and his/her guardian.

Article 19 Vaccines marketed in the territory of China shall be approved by the drug regulatory department under the State Council and shall be granted the drug registration certificate; to apply for vaccine registration, authentic, adequate and reliable data, dossier and samples shall be provided. 

For vaccines urgently needed for disease prevention and control, and innovative vaccines, the drug regulatory department under the State Council shall give priority to evaluation, review and approval. 

Article 20 For vaccines which are used to respond to major public health emergencies or other vaccines which are urgently needed as identified by the competent health department under the State Council, the drug regulatory department under the State Council may grant conditional approval on registration application if benefits of those vaccines outweigh risks based on evaluation. 

When particularly major public health emergencies or other emergencies which seriously threaten public health occur, the competent health department under the State Council shall propose recommendations on the urgent use of vaccines based on the need of disease prevention and control, and after evaluation organized by the drug regulatory department under the State Council, the permission for the urgent use within certain scope and period shall be granted by the drug regulatory department under the State Council.

Article 21 The drug regulatory department under the State Council shall examine and approve the production process, quality control standards, package inserts and labels of vaccines during the approval process of the vaccine registration application. 

The drug regulatory department under the State Council shall publish the content of vaccine package inserts and labels on its websites in a timely manner. 

Chapter III

Vaccine Manufacture and Lot Release

Article 22 The State implements strict access system for vaccine manufacturing. 

To carry out vaccine manufacturing activities, approval shall be obtained from the drug regulatory departments at or above the provincial level, and drug manufacturing certificates shall be obtained. 

In addition to the conditions of drug manufacturing activities stipulated in the Drug Administration Law of the People's Republic of China, the following conditions shall also be met for vaccine manufacturing activities: 

(I) being equipped with appropriate scale and sufficient capacity stockpile; 

(II) possessing systems, facilities and equipment to ensure biological safety; 

(III) meeting the needs of disease prevention and control. 

Vaccine MAHs shall have vaccine production capacity; and where contract production is necessary as demand exceeds the vaccine production capacity,, approval shall be obtained from the drug regulatory department under the State Council. Commissioned production shall comply with this Law and relevant regulations, ensuring the quality of vaccines. 

Article 23 The legal representative and principal responsible person of vaccine MAHs shall have good credit records, and personnel in key positions such as the responsible person for manufacturing management, the responsible person for quality management and the quality authorized person shall have relevant professional background and work experience. 

Vaccine MAHs shall strengthen the training and assessment for personnel of preceding paragraph and in a  timely manner report the employment and change of the aforementioned personnel to the local drug regulatory departments of people's governments of provinces, autonomous regions and municipalities directly under the Central Government. 

Article 24 Vaccines shall be produced and tested in accordance with the approved production process and specifications, and the entire production process shall meet the requirements prescribed by the good manufacturing practice for drugs. 

Vaccine MAHs shall examine and test the whole process of vaccine manufacturing and vaccine quality as required. 

Article 25 Vaccine MAHs shall establish a complete quality management system, unceasingly enhance deviation management, and adopt information-based means to truthfully record all the data formed during manufacturing and testing, in order to ensure the whole process of manufacture persistently meets the legal requirements. 

Article 26 The State implements lot release system for vaccines. 

Each lot of vaccines to be sold or imported shall be examined and tested in accordance with relevant technical requirements by lot release institutions designated by the drug regulatory department under the State Council. A qualified lot shall be granted a certificate for lot release of biological product; and a disqualified lot shall be given a notice of disapproval for lot release. 

Vaccines which are not approved for lot release are prohibited to be sold and shall be destroyed under the supervision of drug regulatory departments of the people's governments of provinces, autonomous regions or municipalities directly under the Central Government; imported vaccines which are not approved for lot release shall be destroyed or handled under the supervision of the drug regulatory department where the port locates in accordance with law. 

The drug regulatory department under the State Council and lot release institutions shall promptly publish the results of the lot release of marketed vaccines for public reference. 

Article 27 To apply for vaccine lot release, materials such as summary protocol of manufacturing and control and samples shall be provided to the lot release institutions as required. For imported vaccines, the certificate of country of origin and certificate of lot release shall also be provided; and if the imported vaccines are exempted from lot release in the country of origin, the exemption certificate of lot release shall be provided. 

Article 28 Vaccines urgently needed to prevent and control outbreaks of infectious diseases or emergencies may be exempted from lot release at the approval of the drug regulatory department under the State Council. 

Article 29 For lot release of vaccines, dossier review and sample testing shall be conducted lot by lot. The testing items and testing frequency for lot release of vaccines shall be dynamically adjusted according to the vaccine quality risk evaluation. 

If there is any doubt about the authenticity of the application dossier or samples for lot release of vaccines or any other situation which requires further verification, lot release institutions shall make the verification, and may organize on-site verifications such as sampling on-site for testing if necessary. 

Article 30 In the case that major quality risks of vaccines are identified during the process of lot release, lot release institutions shall in a timely manner report to the drug regulatory department under the State Council and the drug regulatory departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government. 

The departments which receive the report shall immediately carry out on-site inspection on vaccine MAHs, notify the lot release institutions to disapprove the lot release of relevant products or all products of vaccine MAHs or suspend the lot release procedure based on the inspection results, and order vaccine MAHs to make rectification. Vaccine MAHs shall immediately make rectification and in a timely manner report the rectification progress to the department which gives the order. 

Article 31 Vaccine MAHs shall truthfully record production process deviations, quality deviations, failures and accidents during manufacturing as well as the corresponding measures taken and shall specify them in the document of relevant lot release application; in the case that the quality of vaccines may be affected, vaccine MAHs shall immediately take measures, and report to the drug regulatory departments of the people's governments of provinces, autonomous regions or municipalities directly under the Central Government. 

Chapter IV

Vaccine Distribution

Article 32 For national immunization program vaccines, the centralized bidding or unified negotiation shall be organized by the competent health department under the State Council jointly with the financial and other departments under the State Council. The winning price or transaction price shall be established and released, and each province, autonomous region and municipality directly under the Central Government shall implement unified procurement. 

For immunization program vaccines other than national immunization program vaccines and non-immunization program vaccines, each province, autonomous region and municipality directly under the Central Government shall organize the procurement through the provincial platform for the transaction of public resources. 

Article 33 The price of a vaccine shall be established autonomously and reasonably by its MAHs in accordance with law. The price level, price difference rate and profit rate of a vaccine shall be kept within a reasonable range. 

Article 34 Disease prevention and control institutions at the provincial level shall, in accordance with the national immunization program and the need for disease prevention and control within their administrative regions, formulate plans for the use of immunization program vaccines within their administrative regions, report the plans to the vaccine procurement organizing departments as per relevant national regulations, and simultaneously file the record with the competent health departments under the people's governments of provinces, autonomous regions and municipalities directly under the Central Government. 

Article 35 Vaccine MAHs shall supply vaccines to disease prevention and control institutions in accordance with the procurement contract. 

Disease prevention and control institutions shall supply vaccines to immunization entities as required. 

Entities or individuals other than disease prevention and control institutions shall not supply vaccines to immunization entities, and immunization entities shall not accept such vaccines. 

Article 36 Vaccine MAHs shall deliver vaccines to disease prevention and control institutions or immunization entities designated by disease prevention and control institutions in accordance with the procurement contract. 

Vaccine MAHs and disease prevention and control institutions shall operate under the vaccine cold-chain storage and transportation conditions when delivering vaccines on their own, or they may also entrust qualified vaccine distribution entities to distribute vaccines. 

Disease prevention and control institutions may charge storage and transportation fee for distributing non-immunization program vaccines; the specific measures shall be formulated by the financial department under the State Council in conjunction with the competent pricing department under the State Council; and the charging criteria shall be formulated by the competent pricing departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government in conjunction with the financial departments at the same level.

Article 37 Disease prevention and control institutions, immunization entities, vaccine MAHs and vaccine distribution entities shall comply with the provision for vaccine storage and transportation to ensure vaccine quality. 

Vaccines shall be kept under the stipulated temperature during the whole process of storage and transportation; cold-chain storage and transportation shall comply with requirements, and temperature shall be monitored and recorded on a regular basis. 

The provision for vaccine storage and transportation shall be formulated by the drug regulatory department under the State Council in conjunction with the competent health department under the State Council. 

Article 38 When distributing vaccines, vaccine MAHs shall provide photocopies or electronic documents of the lot release certificates with their seal; when distributing imported vaccines, vaccine MAHs shall additionally provide photocopies or electronic documents of the Drug Import Note with their seal. 

When accepting or purchasing vaccines, disease prevention and control institutions and immunization entities shall ask for the abovementioned supporting documents, and keep such documents for no less than five years upon the expiration date of vaccines for reference.