The State Food and Drug Administration issued the Regulations on the Administration of Vaccine Production and Circulation


Release time:

2022-07-11

In order to implement the requirements of laws and regulations such as the the People's Republic of China Drug Administration Law and the the People's Republic of China Vaccine Administration Law, build a scientific and effective vaccine production and circulation supervision and management system, and regulate the production and circulation management activities of vaccines in accordance with the characteristics of vaccine products and vaccine supervision requirements, the State Food and Drug Administration has organized and formulated the regulations on the Administration of Vaccine production and Circulation, which are hereby promulgated and shall come into force as of the date of promulgation.

Announcement of the State Food and Drug Administration on Issuing the Provisions on the Administration of Vaccine Production and Circulation

(No. 55 of 2022)

 

In order to implement the requirements of laws and regulations such as the the People's Republic of China Drug Administration Law and the the People's Republic of China Vaccine Administration Law, build a scientific and effective vaccine production and circulation supervision and management system, and regulate the production and circulation management activities of vaccines in accordance with the characteristics of vaccine products and vaccine supervision requirements, the State Food and Drug Administration has organized and formulated the regulations on the Administration of Vaccine production and Circulation, which are hereby promulgated and shall come into force as of the date of promulgation.

 

It is hereby announced.

 

State Food and Drug Administration

8 July 2022

 

 

Provisions on Administration of Vaccine Production and Circulation

 

Chapter I General Provisions

 

Article 1 In order to strengthen the supervision and management of vaccine production and circulation, and regulate vaccine production and circulation activities, in accordance with the the People's Republic of China and Drug Administration Law, the the People's Republic of China Vaccine Administration Law, the Drug Registration Administration Measures, the Drug Production Supervision and Administration Measures and other relevant laws and regulations, Regulations and rules, formulate these regulations.

 

Article 2 The present Provisions shall apply to activities such as vaccine production, circulation and supervision and administration within the territory of the People's Republic of China.

 

Article 3 To engage in vaccine production and circulation activities, one shall abide by the relevant laws, regulations, rules, standards and norms of drugs and vaccines, and ensure that the information in the whole process is true, accurate, complete and traceable.

 

Chapter II Holder's Subject Liability

 

Article 4 The State shall implement a marketing authorization holder system for vaccines. The holder shall bear the main responsibility for the safety, effectiveness and quality controllability of the vaccine, carry out the management activities of the production and circulation of the vaccine after it is put on the market in accordance with the law, and bear the corresponding responsibility.

 

If the entrusted production is carried out, the holder shall bear the main responsibility for the entrusted production of the vaccine, and the entrusted vaccine production enterprise shall be responsible for the entrusted production behavior.

 

Article 5 Suppliers of main raw materials, auxiliary materials and packaging materials directly contacting drugs related to vaccine production, as well as relevant subjects such as storage and transportation in the process of vaccine supply, shall bear the responsibilities of corresponding links in accordance with the law.

 

Article 6 The holder shall specify the responsibilities of the personnel in key positions.

 

Legal representative/main person in charge: responsible for establishing quality policies and quality objectives, providing resources to ensure that production, circulation and other activities continue to meet the requirements of relevant laws and regulations, ensuring that the quality management department independently performs its duties, and is fully responsible for the production, circulation activities and quality of vaccine products.

 

Production Management Leader: Responsible for organizing and implementing vaccine product production activities, ensuring that production is organized in accordance with approved production processes and quality control standards, and is responsible for ongoing compliance with the production process.

 

Quality management leader: responsible for organizing the establishment of the enterprise quality management system and ensuring that the system can continue to operate well, responsible for the continuous compliance of vaccine product quality management.

 

Quality authorized person: responsible for the release of vaccine products, ensuring that the production and inspection of each batch of released products meet the approved production process and quality control standards, and is responsible for the release of products.

 

Article 7 The holder's production management person in charge, quality management person in charge, quality authorized person and other key positions shall have a bachelor degree or above in medicine, pharmacy, biology and other related majors, or have an intermediate or above professional and technical title, and have five years The above experience in production quality management in the vaccine field, able to perform duties in production and quality management, and assume corresponding responsibilities.

 

The person in charge of the quality management of vaccine circulation shall have a bachelor's degree or above in medicine, pharmacy, biology and other related majors or have an intermediate professional title or above, have more than three years of experience in vaccine management or technical work, and be able to manage the quality of vaccine circulation. Perform duties and assume corresponding responsibilities.

 

The legal representative, principal person in charge, person in charge of production management, person in charge of quality management and quality authorized person of the holder shall have a good credit record, and the person who has seriously broken the trust of the drug shall not hold the above-mentioned position.

 

Article 8 The holder shall establish a complete vaccine quality management system in accordance with the requirements of laws, regulations, rules, standards, norms, etc., and regularly conduct self-inspection and continuous improvement of the operation of the quality management system.

 

The holder shall, in accordance with the regulations, review and supervise the quality management system of suppliers of raw materials, auxiliary materials, packaging materials directly in contact with drugs, storage and distribution services, etc. involved in vaccine production and circulation, to ensure that the suppliers meet the relevant requirements of vaccine production and circulation, and constantly improve the quality management system of vaccine production and circulation after marketing.

 

Article 9 The holder shall carry out quality risk management in the whole process of vaccine production and circulation, identify, evaluate, control and communicate the risks that may exist in the operation of the quality system, take effective prevention and control measures, and carry out risk review in a timely manner until the risks are effectively controlled.

 

Chapter III Administration of Vaccine Production

 

Article 10 The State shall implement a strict access system for vaccine production and strictly control the establishment of new vaccine production enterprises. In addition to meeting the conditions for the establishment of vaccine production enterprises, newly established vaccine production enterprises shall also comply with the relevant policies of the national vaccine industry authorities.

 

Article 11 The holder itself shall have the vaccine production capacity. When engaging in vaccine production activities, it shall, in accordance with the conditions stipulated in the Drug Administration Law, the Vaccine Administration Law and the measures for the Supervision and Administration of Drug production, and in accordance with the prescribed procedures for the administration of drug production licenses, submit application materials for drug production licenses to the drug supervision and administration department at the provincial level where the production site is located. If it is necessary to entrust production beyond the holder's vaccine production capacity, the entrusted party shall be the drug manufacturer that has obtained the vaccine production scope.

 

The packaging, labeling and sub-packaging of vaccines shall be carried out in the pharmaceutical production enterprises that have obtained the scope of vaccine production.

 

Article 12 The holder may submit an application for the entrusted production of a vaccine under any of the following circumstances:

 

(I) the need for reserve proposed by the industry and information management department of the State Council and considers that the holder's existing production capacity cannot meet the demand;

 

(II) the health administration department of the State Council puts forward an urgent need for disease prevention and control, and considers that the holder's current production capacity cannot meet the demand;

 

(III) the production of polyvalent vaccines.

 

The scope of commissioned production should be the entire process of vaccine production. When necessary, if the production of multi-linked multivalent vaccines is entrusted, it may be the vaccine stock production stage or the preparation production stage after the approval of the State Drug Administration.

 

Article 13 To apply for the entrusted production of vaccines, the entrusting party and the entrusted party shall conduct research, evaluation and necessary verification in accordance with the requirements of relevant technical guidelines, and after completing the change of the production scope of the corresponding Drug Production License, the entrusting party shall apply to the acceptance and reporting center of the State Drug Administration. When applying, the "Application Form for Entrusted Production of Vaccines" (Annex 1) and the application materials (Annex 2) shall be submitted, and the supporting materials specified in Article 12 of these Provisions.

 

Article 14 After receiving an application for entrusted production of vaccines, the Center for Acceptance and Reporting of the State Drug Administration shall conduct a formal review of the application materials in accordance with the requirements of Article 13 of these regulations, and shall make an acceptance, correction or rejection within 5 working days. For a decision on acceptance, a written "Notice of Acceptance" or "Notice of Non-acceptance" shall be issued with a date.

 

Article 15 The SDA shall, in accordance with the requirements of these Provisions, examine the application for entrusted production of vaccines, and shall make a decision within 20 working days. The time required for the applicant to supplement the information shall not be included in the time limit for examination and approval.

 

If it meets the requirements for approval after examination, the Acceptance and Reporting Center of the State Drug Administration shall prepare the "Approval for Entrusted Production of Vaccines" (Annex 3) and issue it to the entrusting party within 10 working days; if it does not meet the requirements, notify the entrusting party in writing and Explain the reasons; if supplementary materials are needed, notify the entrusting party in writing to submit supplementary materials within the specified time.

 

The "Vaccine Commissioned Production Approval" is copied to the provincial drug supervision and administration department where the entrusting party and the entrusted party are located at the same time.

 

Article 16 After obtaining the Approval for Entrusted Production of Vaccines, the entrusting party shall, in accordance with the relevant provisions of the Measures for the Administration of Post-marketing Changes of Drugs (for Trial Implementation), change the registration management matters involved in the change of the production site.

 

The provincial drug supervision and administration department where the entrusting party and the entrusted party are located shall, in accordance with the provisions of Article 52 of the Measures for the Supervision and Administration of Pharmaceutical Production, carry out compliance inspection on the entrusting party and the entrusted party for the quality management of pharmaceutical production.

 

The entrusting party and the entrusted party can only go on sale after completing the corresponding changes in accordance with the law, passing the compliance inspection of the drug production quality management standards, and passing the self-inspection and batch issuance of the products produced, and meeting the statutory release conditions.

 

Article 17 The holder shall establish a complete production quality management system, organize production in strict accordance with the approved production process and quality control standards, and ensure that the products meet the requirements of listing and release. In the production process, material supplier management, change control, deviation management, product quality review and analysis should be continuously strengthened. The use of information means to truthfully record all the data formed in the production and inspection process to ensure that the whole production process continues to meet the statutory requirements. For manual operation steps that cannot be collected online, the data formed by the process shall be entered into the relevant information system or converted into electronic data in a timely manner to ensure the authenticity, accuracy, completeness and traceability of the relevant data, and the relevant original paper records shall be kept as required.

 

Article 18 If the holder plans to stop production for more than 3 months due to process upgrading, relocation and transformation (except for normal periodic production), he shall report to the local provincial drug supervision and administration department 3 months before the suspension.

 

If the holder's perennial production varieties cannot be produced normally due to equipment failure and other emergencies, and it is expected to stop production for more than one month, it shall report to the local provincial drug supervision and administration department within 3 working days of suspension of production.

 

Article 19 If the holder plans to resume production after a long-term suspension of production (except for normal periodic production), he shall report to the local provincial drug regulatory department one month before the resumption of production. The provincial drug supervision and administration department shall conduct risk assessment in combination with the daily supervision situation, and if necessary, carry out on-site inspection on the varieties that resume production.

 

Article 20 In the process of production and circulation management, if the holder discovers major deviations or major quality problems that may affect the quality of vaccine products, he shall immediately report to the provincial drug supervision and administration department where he is located. In the process of circulation management of imported vaccines, if major deviations or major quality problems that may affect the quality of vaccine products are found, the domestic agent designated by the overseas vaccine holder shall report to the provincial drug supervision and administration department where the import port is located. The report includes at least the following:

 

Details of (I) major deviations or quality problems;

 

(II) the product name, batch number, specification, quantity, flow direction and other information;

 

the adverse effects that the (III) has or may have;

 

Emergency control or disposal measures taken by the (IV);

 

(V) further measures to be taken;

 

Other circumstances that should be stated (VI).

 

Article 21 The holder shall establish an annual report system, and the quality annual report shall be written in accordance with the relevant requirements. The annual quality report shall at least include vaccine production and batch issuance, changes in key personnel, changes in production process and site, changes in raw materials and auxiliary materials, changes in key facilities and equipment, deviations, stability inspection, sales and distribution, suspected abnormal vaccination reactions, risk management, inspection and punishment, etc.

 

The holder shall upload the annual quality report of the previous year through the "drug business management system of the national drug intelligent supervision platform" before the end of April each year. The provincial drug supervision and administration departments, the Central Inspection Institute, the Drug Examination Center, the Verification Center, the Evaluation Center, the Information Center and other departments of the State Drug Administration shall, in accordance with their duties and powers, inquire, review, inspect, evaluate and other related work and an important reference for risk assessment.

 

Chapter IV Administration of Vaccine Circulation

 

Article 22 The holder shall sell the vaccine to the disease prevention and control institution in accordance with the provisions of the procurement contract.

 

In principle, an overseas vaccine holder shall designate a domestic drug wholesale enterprise with the ability to ensure the quality of cold chain drugs to uniformly sell its vaccines of the same variety, fulfill the holder's obligations in the sales link, and bear the responsibility.

 

Article 23 When selling vaccines, the holder shall at the same time provide a copy of the batch issuance certificate or an electronic document stamped with his seal; if he sells imported vaccines, he shall also provide a copy of the customs declaration of imported drugs stamped with his seal. Or electronic documents.

 

The holder shall establish a true, accurate and complete sales record in accordance with the regulations. The sales record shall at least include the general name of the product, approval number, batch number, specification, validity period, purchase unit, sales quantity, unit price, amount, sales date and holder information. If the storage and transportation is entrusted, it shall also include the information of the entrusted storage and transportation enterprise, and shall be kept for future reference for not less than 5 years after the expiration of the vaccine validity period.

 

Article 24 when distributing vaccines by the holders and disease prevention and control institutions on their own, they shall have the conditions for cold chain storage and transportation of vaccines, meet the relevant requirements of vaccine storage and transportation management standards, and be responsible for the quality of vaccines distributed according to law.

 

The purchase contract signed between the holder and the disease prevention and control institution shall specify the unit to implement the distribution, the mode of distribution, the time limit for distribution and the place of receipt.

 

Article 25 The holder may entrust enterprises that meet the conditions for the transportation and storage of refrigerated and frozen drugs in accordance with the drug business quality management standards to distribute and store vaccines in the region. The holder shall evaluate the distribution capacity of the vaccine distribution enterprise, strictly control the number of distribution enterprises, and ensure that the distribution process continues to meet the statutory requirements. In principle, the holder shall not select more than 2 vaccine regional distribution enterprises in the same provincial administrative area.

 

Where a disease prevention and control agency entrusts a distribution enterprise to distribute vaccines, it shall evaluate the distribution capacity of the vaccine distribution enterprise to ensure that the cold chain storage and transportation conditions of the vaccine meet the relevant requirements of the vaccine storage and transportation management regulations.

 

Article 26 Where the holder entrusts the distribution of vaccines, it shall promptly report the evaluation of the entrusted distribution of vaccine varieties information, entrusted storage, transportation unit distribution conditions, distribution capabilities and information traceability capabilities to the location of the holder and the location of the receiving vaccine respectively. The provincial drug supervision and administration department shall make a timely announcement. Where a disease prevention and control agency entrusts a distribution enterprise to distribute vaccines, it shall report to the drug regulatory department and the health authority at the same level. The enterprise that accepts the entrusted distribution shall not be entrusted again.

 

Article 27 Holders, disease prevention and control institutions, vaccination units, and related parties entrusted to store and transport enterprises shall, in accordance with the requirements of the national vaccine electronic traceability system, truthfully record the information on the sale, storage, transportation and use of vaccines, so as to achieve the traceability of the whole process from production to use of the smallest packaging unit.

 

The vaccine distribution unit shall, according to the requirements of the holder, record the information of storage and transportation in a true and complete manner.

 

Article 28 For vaccines required under special circumstances such as vaccine non-clinical research, clinical research, and blood product production, the relevant user unit may report to the local provincial drug supervision and administration department, and may report to the vaccine marketing license holder or disease prevention and control Agency procurement. Holders, disease prevention and control institutions and relevant use units shall strictly manage and make relevant records to ensure that the sale and use of vaccines can be traced back.

 

Chapter V Vaccine Change Management

 

Article 29 The holder shall, on the principle of continuously improving the safety, effectiveness and quality controllability of the products, conduct quality tracking and trend analysis of the listed products, improve the production process, improve the control ability of the production process, continuously improve the quality control standards, and improve the quality control level of intermediate products and finished products.

 

Article 30 Where the holder has changed the production process, production site, production workshop and production line, key production facilities and equipment of the vaccine on the market, research and verification shall be carried out to fully evaluate the impact of the change on the safety, effectiveness and quality controllability of the vaccine, the classification of changes shall be determined in accordance with the relevant provisions such as the Measures for the Administration of Post-marketing Changes in Drugs (for Trial Implementation) and the Technical Guidelines for Pharmaceutical Changes in Listed Biological Products (for Trial Implementation), and supplementary applications, records or reports shall be submitted in accordance with the procedures specified in the Measures for the Administration of Drug Registration.

 

Article 31 The holder shall carry out evaluation, demonstration, research and necessary verification of the relevant changes, and if approval or filing is required, it shall be implemented after examination and approval or filing in accordance with the procedures.

 

Article 32 In the event of a change in the production site of the holder, the provincial drug supervision and administration department shall conduct a compliance inspection of the drug production quality management standards; for other changes, the provincial drug supervision and administration department shall determine whether to carry out the compliance inspection of the drug production quality management standards in accordance with the principle of risk management.

 

For the supplementary application matters submitted to the Drug Examination Center of the State Drug Administration, the compliance inspection of drug production quality management standards shall be carried out in accordance with Article 52 of the Measures for the Supervision and Administration of Drug Production.

 

Chapter VI Supervision and Administration of Vaccines

 

Article 33 The SDA shall be in charge of the quality supervision and administration of vaccine production and circulation throughout the country. Formulate rules and regulations, norms, standards and guidelines for the supervision and management of vaccine production and circulation, and supervise and guide the implementation; organize and carry out vaccine inspections and spot checks; supervise and guide the management of vaccine batch issuance, and implement entrusted production approval; work with the competent health department of the State Council to formulate unified vaccines Traceability standards and norms, establish a national vaccine electronic traceability system, and realize the traceability of the entire vaccine process information.

 

The provincial drug supervision and administration departments shall be responsible for the supervision and administration of vaccine production and circulation within their respective administrative areas. Responsible for licensing and filing matters related to vaccine production and circulation; responsible for formulating annual supervision and inspection plans for vaccine production and distribution enterprises and carrying out supervision and inspection; responsible for dispatching inspectors to vaccine production enterprises; responsible for the management of vaccine batch issuance by local drug inspection institutions within their respective administrative regions; and carrying out monitoring and investigation of abnormal reactions to vaccination according to their duties; responsible for guiding the municipal and county departments responsible for drug supervision and management to carry out vaccine quality supervision and management in vaccine circulation and vaccination.

 

The departments responsible for drug supervision and management of cities and counties are responsible for the supervision and management of vaccine quality in the circulation and vaccination of vaccines within their administrative areas; cooperate with the competent health departments to monitor and report abnormal vaccine reactions; improve the quality information notification mechanism and joint disposal mechanism.

 

Article 34 The provincial drug supervision and administration department shall undertake the supervision and management of vaccine production and circulation activities within its administrative area, and supervise and manage the entrusted parties who accept entrusted production and entrusted distribution within the administrative area.

 

If the holder and the entrusted production enterprise are not in the same provincial administrative area, the provincial drug regulatory department where the holder is located shall be responsible for the supervision and management of the holder, and the provincial drug regulatory department where the entrusted production enterprise is located shall be responsible for the supervision and management of the entrusted production enterprise. The provincial drug regulatory department where the holder and the entrusted enterprise are located shall cooperate with each other to carry out supervision and management work, and may carry out joint inspections when necessary.

 

Article 35 The professional and technical institutions established or designated by the drug regulatory department according to law shall undertake the technical work of post-marketing inspection, batch issuance, monitoring of suspected abnormal reactions to vaccination and safety evaluation.

 

(I) and drug inspection agencies are responsible for organizing the drafting of relevant regulations and inspection guidelines for post-marketing inspections of vaccines, and carrying out vaccine inspections in accordance with their duties.

 

The (II) drug review agency is responsible for drafting the relevant regulations and guiding principles of registration management involved in post-marketing changes of vaccines, and carrying out relevant technical review work in accordance with its duties.

 

(III) drug evaluation agencies are responsible for drafting relevant regulations and guiding principles for post-marketing monitoring and safety evaluation of vaccines, and carrying out technical work for post-marketing monitoring and safety evaluation of vaccines in accordance with their duties.

 

The (IV) vaccine batch issuing agency shall promptly notify the relevant drug supervision and administration department of the significant quality risks found in the process of vaccine batch issuance, and the department receiving the report shall initiate vaccine inspection, inspection or quality and safety incident investigation based on the risks.

 

The (V) information management agency is responsible for the construction and management of the vaccine traceability collaborative service platform, vaccine safety credit files, and unified coding of vaccine production sites.

 

The above-mentioned professional and technical institutions for vaccine supervision shall carry out relevant technical activities in accordance with regulations, norms, procedures and standards, and shall be responsible for the results of technical supervision.

 

The higher-level professional technical institution shall guide the quality system construction and business work of the next-level technical institution.

 

Drug supervision and administration departments at all levels and their technical institutions shall establish a vaccine communication, coordination and cooperation mechanism that communicates from top to bottom and from left to right. In the process of on-site inspection of vaccines, monitoring of suspected vaccination abnormal reactions and batch issuance, timely communication of information and notification of the situation; if major product quality risks and serious suspected vaccination abnormal reactions are found, effective measures shall be taken immediately to control the risks.

 

Article 36 In implementing post-marketing supervision and inspection of vaccines, in addition to complying with the general provisions of the Measures for the Supervision and Administration of Drug Production and the Measures for the Administration of Drug Inspection (for Trial Implementation), the drug regulatory department shall also carry out inspections in the following ways:

 

The (I) National Drug Administration organizes the National Vaccine Inspection Center to conduct inspections on the production and quality management of vaccine manufacturers in production, and supervise the supervision and management of vaccine production by provincial drug supervision and management departments.

 

(II) provincial drug supervision and administration departments shall carry out supervision and inspection of vaccine production enterprises, distribution enterprises and drug wholesale enterprises selling imported vaccines in their respective administrative regions, and cooperate with the State Drug Administration to do a good job in vaccine inspection and spot check; carry out supervision and inspection of vaccine distribution enterprises and disease prevention and control institutions at the same level; When necessary, extended supervision and inspection shall be carried out on units providing products or services in vaccine production, circulation and other activities.

 

The departments responsible for drug supervision and administration of cities and counties are (III) to carry out quality supervision and inspection of disease prevention and control institutions and vaccination units.

 

Article 37 The departments responsible for drug supervision and administration at all levels shall, in accordance with their duties, formulate inspection plans in accordance with the principles of quality risk management when conducting supervision and inspection of holders, entrusted production enterprises, vaccine distribution enterprises, disease prevention and control institutions and vaccination units, according to the previous on-site inspection, quality annual report, listing license change declaration, post-listing quality sampling, batch issuance, suspected vaccination abnormal reaction monitoring, product recall information, complaint reporting, etc. to carry out risk assessment and formulate inspection plan. Inspection frequency, inspection scope, key content, inspection duration and professional background of the inspector shall be considered in the preparation of inspection plan.

 

The departments responsible for drug supervision and administration at all levels may, in accordance with the inspection plan and scheme, carry out on-site inspection on the production sites, business premises, vaccine distribution enterprises, disease prevention and control institutions and vaccination units of the holders, and the units under inspection shall cooperate and shall not refuse, evade or hinder them. In the process of on-site inspection, relevant evidence can be collected, and relevant materials and objects collected according to law can be used as the basis for determining facts in administrative punishment; if samples need to be taken for inspection, they can be sampled in accordance with the relevant provisions of sampling inspection or notify the local drug supervision and administration department of the inspected unit to sample according to the regulations, and the samples taken shall be inspected by qualified technical institutions.

 

Article 38 The provincial drug supervision and administration department shall assign at least two inspectors to each vaccine production enterprise within its administrative area. The stationed inspectors shall do the following inspection work:

 

(I) complete the inspection tasks set by the provincial drug supervision and administration department as required, report the supervision and inspection situation to the provincial drug supervision and administration department in a timely manner, and put forward supervision suggestions;

 

(II) check the defective items found by the provincial pharmaceutical supervisory and administrative departments, urge enterprises to make rectification on schedule and verify the rectification;

 

(III) assist the approval issuing institution to carry out on-site verification and other work;

 

When the (IV) discovers the enterprise's illegal clues, it shall immediately report to the dispatched department and cooperate with the supervision department to collect evidence;

 

(V) complete other tasks assigned by the provincial drug regulatory authorities.

 

Article 39 The State Drug Administration shall organize the National Vaccine Inspection Center to carry out at least one vaccine inspection on the holders of vaccines in production every year; the provincial drug supervision and administration department shall inspect the holders of vaccines in production and their entrusted production enterprises at least twice a year, including at least one inspection of the compliance of drug production quality management standards, the drug wholesale enterprises, vaccine distribution enterprises and disease prevention and control institutions at the same level that sell imported vaccines shall be inspected at least once a year; the departments responsible for drug supervision and administration at the city and county shall inspect the disease prevention and control institutions and vaccination units at the same level at least once a year. If clues that may have a significant impact on the quality of the vaccine are found, the drug supervision and administration departments at all levels can carry out cause-based inspections at any time.

 

Article 40 The inspection team shall put forward on-site inspection conclusions based on the on-site inspection, form an on-site inspection report, and submit it to the dispatched drug inspection agency in a timely manner. The drug inspection agency shall evaluate and review the on-site inspection report, form a comprehensive evaluation conclusion in combination with the rectification situation of the enterprise, and submit it to the drug supervision and administration department. The drug supervision and administration department shall make corresponding treatment according to the comprehensive evaluation conclusion.

 

If the inspection finds that the holder has defective items, the local provincial drug supervision and administration department shall urge the holder to carry out rectification in accordance with its duties, and the rectification shall be verified after the rectification is completed.

 

If the inspection finds that the holder has major quality hazards or risks, the local provincial drug supervision and administration department shall immediately take corresponding administrative measures to control the risks in accordance with its duties, and report to the State Drug Administration in a timely manner.

 

If the inspection finds that the holder, the entrusted production enterprise, or the vaccine distribution enterprise has violated laws and regulations, the local drug supervision and administration department shall conduct an investigation in accordance with its duties and deal with it in accordance with the "Drug Administration Law" and "Vaccine Administration Law.

 

If the inspection finds that the holder, vaccine distribution enterprise, disease prevention and control institution or vaccination unit violates the management requirements of vaccine storage and transportation and may affect the quality of vaccine, the local drug supervision and administration department shall order it to suspend the sale, distribution or distribution of vaccine, notify the health department at the same level, and urge the relevant units to carry out rectification. After the rectification is completed, the sales, distribution or distribution of vaccines can be resumed only if the local drug supervision and administration department meets the requirements.

 

Article 41 the holder shall, in accordance with the provisions of the measures for the Administration of Drug recall, establish a sound drug recall management system, collect relevant information on vaccine safety, investigate and evaluate the quality problems or other potential safety hazards that may endanger human health and life safety, and recall defective vaccines.

 

After investigation and evaluation, the drug regulatory department believes that the vaccine has quality problems or other safety hazards that may endanger human health and life safety, and the holder shall recall the vaccine without taking the initiative to recall, it shall order the holder to recall the vaccine.

 

Article 42 If there are suspected abnormal vaccination reactions or group adverse events in vaccines, the competent health department shall organize experts to investigate and diagnose or suspect that it is related to the quality of the vaccine, or the vaccine quality and safety information found in daily supervision and inspection and risk monitoring, and Other vaccine quality and safety incidents that seriously affect public health shall be dealt with in accordance with the relevant emergency plans of the local people's government.

 

Article 43 Vaccine production enterprises engaged in vaccine export shall produce and export vaccines in accordance with the requirements of international procurement. Vaccine production enterprises shall directly sell vaccines for export only to overseas countries and shall not sell them within the territory of China. Vaccines may not be imported into the country after export.

 

Chapter VII Supplementary Provisions

 

Article 44 The present Provisions shall enter into force as of the date of promulgation.

 

Source: National Drug Administration website