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Laws & Regulations - Drugs - Provisions for Reporting and Monitoring of Adverse Drug Reactions
Provisions for Reporting and Monitoring of Adverse Drug Reactions
 
2012/3/20 14:25:10¡¡Source: ¡¡Hits:

Chapter 1 General Provisions
Article 1 The Provisions are formulated with a view of strengthening supervision on safety of drugs on the market, standardizing administration on reporting and monitoring of adverse drug reactions (ADR) and ensuring drug safety for the public, in accordance with the Drug Administration Law of the People¡¯s Republic of China.

Article 2 The State adopts an ADR reporting system. Drug manufacturers, drug distributors and medical and health institutions shall report as required any adverse drug reaction(s) found. 

Article 3 The State Food and Drug Administration is responsible for ADR monitoring across the country; the (food and) drug regulatory departments of the people¡¯s government of various provinces, autonomous regions and municipalities directly under the Central Government are responsible for ADR monitoring within their respective administrative areas; competent departments of health at all levels are responsible for the administration with respect to implementing the ADR reporting system in medical and health institutions.

Article 4 The Provisions apply to drug manufacturers, distributors, medical and health institutions, professional ADR monitoring institutions, (food and) drug regulatory departments and other relevant competent departments within the territory of the People's Republic of China.

Article 5 The State encourages relevant organizations and individuals to report adverse drug reactions.

Chapter 2 Responsibilities
Article 6 The State Food and Drug Administration is responsible for ADR monitoring across the country and fulfilling the following major responsibilities:
(1) Formulating regulations and policies for ADR reporting jointly with the Ministry of Health and supervising their implementation;
(2) Circulating information on ADR reporting and monitoring across the country;
(3) Organizing inspection over ADR reporting and monitoring by drug manufacturers and distributors, and jointly organizing inspection with the Ministry of Health over ADR reporting and monitoring by medical and health institutions;
(4) Organizing investigation of, confirming and handling adverse drug reactions that suddenly occur, break out among groups of people or have a significant impact and serious consequences;
(5) For a drug that has been confirmed as having caused a serious adverse reaction, the State Food and Drug Administration may take emergency measures and make an administrative decision in accordance with law.

Article 7 The (food and) drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government are responsible for ADR monitoring within their respective administrative areas and fulfilling the following main responsibilities:
(1) Formulating regulations for ADR reporting and administration within their respective administrative areas jointly with the competent departments of health at the same level according to the Provisions and supervising their implementation;
(2) Organizing publicity, education and training on ADR reporting and monitoring within their respective administrative areas jointly with the competent departments of health at the same level;
(3) Organizing inspection over ADR reporting and monitoring by drug manufacturers and distributors within their respective administrative areas, and organizing inspection jointly with the competent departments of health at the same level over ADR reporting and monitoring by medical and health institutions within their respective administrative areas;
(4) Organizing investigation, confirming and handling serious adverse drug reactions that occur within their respective administrative areas;
(5) For a drug that has been confirmed as having caused serious adverse reactions, the (food and) drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government may take emergency measures and make an administrative decision in accordance with law.

Article 8 The competent department of health under the State Council and local health departments at various levels shall take relevant emergency measures for confirmed adverse drug reactions within their respective scopes of responsibilities in accordance with law.

Article 9 The National Center for ADR Monitoring undertakes technical work for ADR monitoring across the country and fulfills the following main responsibilities under the leadership of the State Food and Drug Administration.
(1) Collecting, evaluating and responding to ADR reports across the country and submit the reports to higher authority;
(2) Providing technical guidance to ADR monitoring centers of provinces, autonomous regions and municipalities directly under the Central Government;
(3) Undertaking construction and maintenance of the national ADR database and the monitoring network;
(4) Organizing publicity, education, training on adverse drug reactions, and editing and publication of journals on ADR information;
(5) Participating in international exchange of ADR monitoring;
(6) Organizing research on ADR monitoring methods.

Article 10 ADR monitoring centers of provinces, autonomous regions and municipalities directly under the Central Government shall collect, verify, evaluate, respond to ADR reports within their respective administrative areas, submit the reports to the superior and undertake other relevant work under the leadership of the (food and) drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government.

Article 11 Staff of the ADR monitoring centers shall have knowledge in medicine, pharmacy and relevant fields and the ability to correctly analyze ADR reports.

Chapter 3 Reporting
Article 12 Adverse drug reactions shall be reported level by level and at regular intervals, and if necessary, may be reported to a higher level with the immediate leadership bypassed.

Article 13 A drug manufacturer, distributor or medical and health institution must designate a full-time (part-time) person to take charge of ADR reporting and monitoring of drugs that it produces, distributes or uses. If an adverse reaction is found relevant to the use of a drug, it shall record in detail, investigate, analyze, evaluate and handle the reaction and fill out a Report of Adverse Drug Reaction/Event. The adverse drug reactions shall be summed up and reported to the local ADR monitoring center of the province, autonomous region or municipality directly under the Central Government each quarter of a year. A new or serious adverse drug reaction shall be reported within 15 days from the date of discovery; cases involving death shall be reported timely.

Article 14 The information provided in the Report of Adverse Drug Reaction/Event shall be true, complete and accurate.

Article 15 All adverse reactions of a drug within the new drug monitoring period shall be reported; for a drug of which the new drug monitoring period is ended, new and serious adverse reaction(s) induced by the drug shall be reported.
Apart from reporting in accordance with the provisions of Article 13, a drug manufacturer shall also make an annual summary in the form of a Regular Summary of Adverse Drug Reaction/Event and report to the local ADR monitoring center of the province, autonomous region and municipality directly under the Central Government. For a drug within its new drug monitoring period, a summary shall be made and reported each year; for a drug of which its new drug monitoring period is ended, a summary shall be made and reported in the year in which the first approval document of the drug expires, and later on, a summary shall be made and reported every five years.

Article 16 All the adverse reactions of an imported drug shall be reported within five years from the day the impor

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