Quote from VigiServe Admin on January 2, 2021, 2:28 PM

Chapter 6 　 Abnormal Reaction Monitoring and Management

"Article 52" Abnormal response to preventive vaccination refers to an adverse drug reaction in which a qualified vaccine causes damage to the tissues, organs and functions of the recipient during or after the implementation of standardized vaccination, and the relevant parties are not at fault.

The following situations are not considered abnormal reactions to vaccination:

(1) General reaction after vaccination caused by the characteristics of the vaccine itself;

(2) Damage to the recipient caused by the quality of the vaccine;

(3) Damage to the recipient caused by the inoculation unit's violation of the work norms of preventive vaccination, immunization procedures, guidelines for the use of vaccines, and vaccination programs;

(4) The recipient was in the incubation period or prodromal period of a certain disease at the time of vaccination, and the disease happened occasionally after vaccination;

(5) The recipient has the vaccination contraindications stipulated in the vaccine manual, and the recipient or his guardian did not truthfully provide the recipient’s health status and vaccination contraindications before vaccination, and the recipient’s original disease has acute recurrence or condition after vaccination Aggravate

(6) Individual or group psychogenic reactions due to psychological factors.

Article 53　The state strengthens monitoring of abnormal reactions to vaccination. The monitoring plan for abnormal response of vaccination shall be formulated by the competent health department of the State Council in conjunction with the drug regulatory department of the State Council.

Article 54 　 Vaccination units, medical institutions, etc. shall report to the disease prevention and control agency in accordance with regulations if they find a suspected abnormal response to vaccination.

Vaccine marketing permit holders should set up a special agency with full-time personnel to actively collect, track and analyze suspected abnormal vaccination reactions, take timely risk control measures, report suspected vaccination abnormal reactions to disease prevention and control agencies, and submit quality analysis reports Drug supervision and administration departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government.

Article 55 　 In response to a suspected abnormal response to vaccination, the disease prevention and control agency shall promptly report in accordance with regulations, organize investigation and diagnosis, and inform the recipient or his guardian of the investigation and diagnosis conclusion. If there is a dispute over the conclusion of the investigation or diagnosis, an application for identification may be made in accordance with the identification method formulated by the health authority under the State Council.

Suspected vaccination abnormal reactions that have a major impact on society, such as the death or severe disability of the recipient due to vaccination, or the group suspected abnormal vaccination reaction that have a major impact on the society, shall be managed by the health authorities and drug supervision and management of the people's government at or above the districted city level The departments organize investigations and handling according to their respective responsibilities.

Article 56　The state implements a compensation system for abnormal response to vaccination. If damages such as death, severe disability, organ tissue damage, etc. occur during or after the implementation of the vaccination, which is an abnormal response to the vaccination or cannot be eliminated, compensation shall be given. The scope of compensation is managed by catalog and adjusted dynamically according to actual conditions.

Compensation costs for vaccination plan vaccines shall be arranged by the financial departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government in the vaccination funds; compensation costs for vaccination of non-immunization plan vaccines shall be borne by the relevant vaccine marketing license holders. The state encourages the use of commercial insurance and other forms to compensate recipients of abnormal reactions to vaccination.

Compensation for abnormal response of vaccination shall be timely, convenient and reasonable. The scope, standards, and procedures of compensation for abnormal reactions of vaccination shall be stipulated by the State Council, and specific implementation measures shall be formulated by provinces, autonomous regions and municipalities directly under the Central Government.

Chapter Seven 　 Post-marketing vaccine management

Article 57 Holders of vaccine marketing permits shall establish and improve the quality management system for the whole life cycle of vaccines, formulate and implement post-marketing risk management plans for vaccines, carry out post-marketing vaccine research, and control the safety, effectiveness and quality of vaccines For further confirmation.

For vaccines for which further research requirements are requested when the vaccine registration application is approved, the vaccine marketing license holder shall complete the research within the prescribed time limit; if the research is not completed within the specified time period or cannot be proved that the benefits outweigh the risks, the drug regulatory department of the State Council shall handle it in accordance with the law. Until the drug registration certificate of the vaccine is cancelled.

Article 58　The holder of the vaccine marketing license shall conduct a quality tracking analysis of the vaccine, continuously improve the quality control standards, improve the production process, and increase the stability of the production process.

Changes in the production process, production site, key equipment, etc. shall be evaluated and verified, and filed or reported in accordance with the relevant change management regulations of the drug regulatory department of the State Council; where the change may affect the safety, effectiveness and quality controllability of the vaccine, It shall be approved by the drug regulatory department of the State Council.

Article 59 　 The holder of the vaccine marketing authorization shall continuously update the instructions and labels according to the post-marketing research of the vaccine and prevent the abnormal reaction of vaccination, and apply for approval or filing in accordance with regulations.

The drug regulatory department of the State Council shall promptly publish updated vaccine instructions and label contents on its website.

Article 60 　Vaccine marketing license holders shall establish a vaccine quality review analysis and risk reporting system, and report the production and circulation of vaccines, post-marketing research, risk management and other information to the State Council's drug regulatory authority in accordance with regulations.

Article 61　The drug regulatory authority under the State Council may, based on actual conditions, order vaccine marketing license holders to carry out post-marketing evaluations or directly organize post-marketing evaluations.

For vaccines that have a serious abnormal response to vaccination or that endanger human health for other reasons, the drug regulatory department of the State Council shall cancel the drug registration certificate of the vaccine.

Article 62 The drug regulatory department of the State Council may organize the post-marketing evaluation of vaccine varieties according to the needs of disease prevention and control and the development of the vaccine industry, and discover the product design, production process, safety, effectiveness or quality of the vaccine variety If the controllability is obviously inferior to other vaccine varieties that prevent or control the same disease, the drug registration certificates of all vaccines of that variety shall be cancelled and the corresponding national drug standards shall be abolished.