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Pharmaceutical & Cosmetic
Provisions for Reporting and Monitoring of Adverse Drug Reactions
    Pubtime: 2012-03-20

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 import is permitted for the first time; after the five years, new and serious adverse reactions of the imported drug shall be reported. Besides, an annual summary of adverse reactions of an imported drug shall be made and reported within five years from the date the import is permitted for the first time; after the five years, a summary shall be made and reported every five years.
Where a new or serious adverse reaction of an import drug occurs in another country or region, the agent of the import drug shall report to the National Center for ADR Monitoring within one month from the date of discovery.

Article 17 Where a drug manufacturer, distributor or medical and health institution finds an adverse drug reaction among groups of people, it shall immediately report to the local (food and) drug administration, health bureau and ADR monitoring center of the province, autonomous region or municipality directly under the Central Government. The (food and) drug administration of the province, autonomous region or municipality directly under the Central Government shall immediately organize investigation and verification jointly with the health bureau at the same level, and report to the State Food and Drug Administration, Ministry of Health and National Center for ADR Monitoring.

Article 18 Any individual who finds a new or serious adverse reaction of a drug may directly report to the local ADR monitoring center or (food and) drug administration of the province, autonomous region or municipality directly under the Central Government.

Article 19 The ADR monitoring center of a province, autonomous region or municipality directly under the Central Government shall report collected common adverse reactions to the National Center for ADR Monitoring each quarter of a year, and shall verify and report new or serious adverse reactions within three days of receiving a report, and meanwhile copy to the (food and) drug administration and health bureau of the province, autonomous region or municipality directly under the Central Government; and shall report to the National Center for ADR Monitoring the periodic summary reports collected each year.

Article 20 The National Center for ADR Monitoring shall submit statistics on ADR monitoring to the State Food and Drug Administration and the Ministry of Health every half a year; new or serious adverse reaction reports and reports of adverse reactions among groups of people shall be submitted timely after analysis and evaluation.

Article 21 An ADR monitoring center shall give its feedback to any organization or individual that reports an adverse drug reaction.

Chapter 4 Evaluation and Control
Article 22 A drug manufacturer, distributor or medical and health institution shall regularly analyze and evaluate adverse reactions of the drugs produced, distributed or used on their own and take effective measures to reduce or prevent the recurrence of any adverse drug reaction.

Article 23 The ADR monitoring center of a province, autonomous region or municipality directly under the Central Government shall timely verify any ADR report, make an objective, scientific and comprehensive analysis, give its correlation assessment opinion, and submit the analysis and assessment opinion to the National Center for ADR Monitoring for further analysis and assessment.

Article 24 Based on the result of analysis and assessment, the State Food and Drug Administration may take measures such as giving instructions on modifying the insert sheet and suspending production, sale and use; for any drug harmful to human health due to significant adverse reactions or other reasons, its approval document shall be revoked, which shall be made known to the public.
A drug with its approval document revoked shall not be produced or imported, sold and used; that having been produced or imported shall be destroyed or disposed of by the local (food and) drug regulatory department.

Article 25 A drug that has been confirmed as having caused serious adverse reactions shall be disposed of in accordance with relevant provisions in Article 71 of the Drug Administration Law.

Article 26 The State Food and Drug Administration shall regularly circulate ADR reporting and monitoring information across the country.

Chapter 5 Penalties
Article 27 For a drug manufacturer, distributor or user other than a medical institution involved in any of the following circumstances, depending on the severity of the case, a (food and) drug regulatory department above the provincial level shall order rectification, circulate a notice of criticism or give a warning, and impose a fine of not less than RMB 1,000 yuan and not more than RMB 30,000 yuan; where the situation is serious and results in harmful consequences, a punishment shall be imposed in accordance with relevant law and regulations.
(1) No full-time or part-time person is appointed to take charge of monitoring adverse drug reactions for the organization;
(2) Not reporting adverse drug reaction as required;
(3) An adverse drug reaction found is concealed and not reported;
(4) Not revising an insert sheet as required;
(5) Information on an adverse drug reaction is concealed.
Where a medical and health institution commits any of the above acts, the (food) and drug regulatory department shall turn over the case to the competent department of health at the same level for handling.

Article 28 Where a (food and) drug regulatory department or its relevant personnel violates relevant rules during ADR monitoring, delays ADR report or fails to take effective measures to prevent recurrence of a serious adverse drug reaction, and has caused serious consequences, administrative sanctions shall be given in accordance with relevant regulations.

Chapter 6 Supplementary Provisions
Article 29 Definitions of the following terms in the Provisions:
(1) Adverse drug reaction: a harmful reaction that occurs irrespective of the intended use or unexpectedly when a qualified drug is used in its normal dose and administration method.
(2) ADR reporting and monitoring: the process of discovering, reporting, evaluating and controlling an adverse drug reaction.
(3) New adverse drug reaction: an adverse reaction that is not specified in the insert sheet.
(4) Serious adverse drug reaction: a drug reaction that leads to any of the following situations:
1. Death;
2. Cancer, deformity and birth defect;
3. Life-threatening, permanent or distinctive impairment and physical disabilities;
4. Permanent organ damages;
5. Hospitalization or prolonged hospitalization.

Article 30 ADR reports and statistics are the basis for strengthening drug supervision and directing rational use of drugs and shall not be regarded as the basis for handling medical accidents, medical lawsuits and drug quality-related accidents.

Article 31 Specific implementing rules of the provisions for ADR reporting and monitoring for the Chinese People's Liberation Army shall be formulated in accordance with the Provisions.

Article 32 The State Food and Drug Administration shall interpret the Provisions jointly with the Ministry of Health.

Article 33 The Provisions shall go into effect as of the date of promulgation. The previous Provisions for Reporting and Monitoring of Adverse Drug Reactions (trial) jointly promulgated by the State Food and Drug Administration and the Ministry of Health on November 26, 1999 shall be annulled there from.

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