(March 4, 2004, the State food and drug administration, Ministry of health, the 7th release) Chapter I General provisions article to strengthen the safety of marketed drugs, regulate the management of adverse drug reaction reporting and monitoring, protection of public safety, in accordance with the People's Republic of China Law on drug management procedures are formulated. Article II country reporting system of adverse drug reaction.     Pharmaceutical producing enterprises, trading enterprises and medical institutions should be required to report adverse drug reactions that are found.     Article III the State food and drug administration competent national adverse drug reaction monitoring, Governments of provinces, autonomous regions and municipalities (food) within the administrative area of drug administration in charge of the adverse drug reaction monitoring, health authorities are responsible for medical and health institutions at all levels with regard to the implementation of the adverse drug reaction reporting system management.     Fourth article this approach applies to People's Republic of China territory of drug production, trading enterprises and medical organizations, specialized agency for monitoring of adverse drug reaction, (food) and other drug regulatory authorities.     The fifth State shall encourage units and individuals to report adverse drug reactions. Second chapter duties sixth article national food drug supervision authority is responsible for national drug bad reaction monitoring management work, and perform following main duties: (a) with Ministry of health developed drug bad reaction report of management regulations and policy, and supervision implementation; (ii) informed national drug bad reaction report and monitoring situation; (three) organization check drug production, and business enterprise of drug bad reaction report and monitoring work of carried out situation,     And with Ministry of Health Organization check medical health institutions of drug bad reaction report and monitoring work of carried out situation; (four) on burst, and mass, and effect larger and caused serious consequences of drug bad reaction organization survey, and confirmed and processing; (five) on has confirmed occurred serious bad reaction of drug, national food drug supervision authority can take emergency control measures, and law made administrative processing decided. Seventh article province, and autonomous regions, and municipalities (food) drug supervision authority is responsible for this administrative within drug bad reaction monitoring management work, and perform following main duties: (a) according to this approach with sibling health competent sector business version administrative within drug bad reaction report and the management provides, and supervision implementation; (ii) with sibling health competent sector organization this administrative within drug bad reaction report and monitoring of publicity, and education, and training work; (three) organization check this administrative within drug production, and Business enterprise of drug bad reaction report and monitoring work of carried out situation, and with sibling health competent sector organization check this administrative within medical health institutions of drug bad reaction report and monitoring work of carried out situation; (four) on this administrative within occurred of drug serious bad reaction organization survey, and confirmed and processing; (five) on in this administrative within has confirmed occurred serious bad reaction of drug, province, and autonomous regions, and municipalities (food) drug supervision authority can take emergency control measures,     And shall make a decision of administrative handling.     Eighth State health authorities and local health authorities within the terms of reference, in accordance with the identified adverse drug reaction to take emergency measures. Nineth article national drug bad reaction monitoring center hosted national drug bad reaction monitoring technology work, in national food drug supervision authority of led Xia perform following main duties: (a) bear national drug bad reaction report information of collection, and evaluation, and feedback and reported work; (ii) on province, and autonomous regions, and municipalities drug bad reaction monitoring Center for technical guidance; (three) hosted national drug bad reaction information information library and monitoring network of construction and the maintenance work; (four) Organization drug bad reaction publicity, and     Education, training and ADR information publication edited and published work (v) participation in the exchange of international adverse drug reaction monitoring (vi) organizes study on adverse drug reaction monitoring.     Tenth of provinces, autonomous regions and municipalities directly under the Center for adverse drug reaction monitoring in the provinces, autonomous regions and municipalities directly under the (food) and drug administration under the leadership of contractors within the administrative area of the adverse drug reaction report data collection, validation, evaluation, feedback, reporting and other related work.     11th adverse drug reaction monitoring center personnel should have medical, pharmaceutical and related expertise, has the ability to correct analysis of the adverse drug reaction reporting information.     Chapter reporting adverse drug reactions to implement step by step the 12th article, regular reporting and, if necessary, can leapfrog report. 13th article drug production, and business enterprise and medical health institutions must specified designed (and) vocational personnel is responsible for this units production, and business, and using drug of bad reaction report and monitoring work, found may and medication about of bad reaction should detailed records, and survey, and analysis, and evaluation, and processing, and fill in drug bad reaction/event report table, each quarter concentrated to location of province, and autonomous regions, and municipalities drug bad reaction monitoring Center report,     New or serious adverse drug reactions should be reported from the date of discovery in the 15th and deaths be reported.     14th article of the adverse drug reaction/event reporting form fill in content should be true, complete and accurate.     15th new monitoring period should report on the drug of all adverse drug reactions; drug monitoring period is full of drugs, reported the cause new and serious adverse drug reactions. Drug manufacturers with the exception provided for by the 13th report, should also be based on the adverse drug reaction/event in the form of summary tables on a regular basis after a year, to the seat of the province, autonomous region, municipality directly under the Center for adverse drug reaction monitoring reported.     New drugs drugs during the monitoring period, summary report once a year; for drug monitoring period is full of drugs, and in the year of expiry of the current drug approval documents for the first time summary reports, summary report once every 5 years. 16th imported drugs approved within 5 years from the date of import for the first time, reports that the import of all adverse drug reaction; less than 5 years, report the import of new and serious adverse drug reactions.     In addition, the imported drugs should also undertake an annual summary reports of adverse reactions that occurred, imported drugs approved within 5 years from the date of import for the first time, summary report once a year; less than 5 years, summary report once every 5 years.     Imported drugs in other countries and regions new or serious adverse reaction, agency management of the imported drugs unit should be observed on adverse reactions report within one month from the date of National Center for adverse drug reaction monitoring. 17th pharmaceutical production, management of enterprises and medical institutions found that adverse community reaction, immediately to the location of the provinces, autonomous regions and municipalities (food) Drug Administration, the Health Department (Bureau) as well as adverse drug reaction monitoring Center reported.     Provinces, autonomous regions and municipalities (food) and Drug Administration should immediately in conjunction with the Department of health (Board) organizations investigation and verification, and the State food and drug administration, Ministry of health and the National Center for adverse drug reaction monitoring reported.     Article 18th found caused by new or serious adverse drug reactions, directly to the seat of the provinces, autonomous regions, municipalities or adverse drug reaction monitoring Center (food) and Drug Administration report.     19th article province, and autonomous regions, and municipalities drug bad reaction monitoring center, should each quarter to national drug bad reaction monitoring Center report by collection of General bad reaction report; on new of or serious of bad reaction report should for verified, and Yu received report of day up 3rd within report, while copy this province, and autonomous regions, and municipalities (food) drug supervision authority and Health Office (Council); annual to national drug bad reaction monitoring Center report by collection of regularly summary report.     The 20th National Center for adverse drug reaction monitoring every six months to the State food and drug administration and the Ministry of health reports statistics on adverse drug reaction monitoring, including new or serious adverse reaction reporting adverse reaction reporting and group information analysis and evaluation reports in a timely manner.     21st Center for adverse drug reaction monitoring the reporting of adverse drug reactions unit or personal feedback information.     Evaluation and control of the fourth chapter 22nd drug-producing, trading enterprises and medical organizations should be kept on the production, distribution, use, analysis, and evaluation of drug adverse reactions that have taken place, and should take effective measures to reduce and prevent the recurrence of adverse drug reactions.     23rd of provinces, autonomous regions and municipalities directly under the Center for adverse drug reaction monitoring to verify adverse drug reaction reports in a timely manner, make an objective, scientific and comprehensive analysis of the proposed Association comments, analysis and evaluation reported to the National Center for ADR monitoring, by the National Center for adverse drug reaction monitoring for further analysis and evaluation.     24th based on the evaluation results, the State food and Drug Administration ordered to modify the drug can be taken, a moratorium on the production, distribution and use measure; adverse drug reactions or have other reason harmful to human health, shall withdraw the drug approval documents, and to the public.     Of medicines has been revoked approval documents shall not manufacture or import, sale and use have been produced or imported by the local (food) drug supervision and management departments supervise the destruction or disposal.     25th confirmed serious adverse reaction of drugs, in accordance with the rules of drug administration law the 71st for processing.     26th State food and Drug Administration report regularly to the national adverse drug reaction reporting and monitoring.     Fifth chapter punishment 27th article provincial above (food) drug supervision management sector on drug production, and business enterprise and except medical institutions outside of drug using units has following case one of of, depending on plot serious degree, be ordered corrected, and informed criticism or warning, and can sentenced 1000 Yuan above 30,000 yuan following of fine; plot serious and caused bad consequences of, according to about legal regulations of provides for punishment.     (A) no full-time or part-time officer in charge of the monitoring of adverse drug reactions, (ii) failure to report adverse drug reactions, and (iii) found that adverse drug reactions were hidden and not reported; (d) the failure to amend the drug (v) concealing adverse drug reaction data.     Medical and health institutions of any of the above acts, the (food) Drug Administration transferred health authorities at the same level for processing.     28th (food) drug supervision and management departments and staff concerned in the management of adverse drug reactions monitoring violations, delays, adverse reaction reports, failed to take effective measures to control the serious adverse drug reactions recur and cause serious consequences, in accordance with the relevant provisions of administrative sanctions.     The sixth chapter supplementary articles article 29th of this approach is the meaning of the following terms: (a) adverse drug reactions occurred under normal usage, refers to the qualified drug and unrelated to the medication or unexpected adverse reactions.     (B) refers to adverse drug reaction reporting and monitoring of adverse drug reaction of discovery, reporting, evaluation and control of the process.     (C) the new ADR refers to drug adverse reactions that are not set out in the specifications.     (D) refers to taking serious adverse drug reaction following damage caused by one of the drug reactions: 1. cause of death, 2. birth defects caused by carcinogenic, teratogenic, 3. lives are in danger and can cause permanent or significant disability, 4. permanent damage to organs function; 5. hospitalization and longer hospital stays.     30th of adverse drug reaction reports and statistical information is the basis for strengthening drug administration, guide rational drug use, not as a medical accident, medical and treatment of quality accident of action according to.     31st people's Liberation Army's adverse drug reaction reporting and monitoring measures shall be formulated in accordance with the measures specific measures for its implementation.     32nd article this way by the State food and drug administration, in conjunction with the Ministry of health should be interpreted. 33rd article this way as of the date of promulgation.     State Drug Administration and on November 26, 1999, the Ministry of health jointly issued the administrative measures for adverse drug reaction monitoring (trial) be repealed simultaneously.                                Annexes: 1. adverse drug reaction/event reporting form 2. adverse reaction/event reporting drug groups table 3. adverse drug reaction/event summary tables Annex 1 on a regular basis: • adverse drug reaction/event analysis 1. medication and adverse reactions/events appear with or without a reasonable amount of time?                                  -None-2. response is consistent with the drug known types of adverse reactions?            Yes-No-unknown-3. after discontinuation or reduction, whether the reaction/event disappeared or decreased?            Yes-No-unknown-no stopping or not reduction-4. using suspicious again after a recurrence of the same drug reaction/event? Unknown-no longer available-Yes-No-5. reaction/event is available and treatment, the patient's progress, other treatment to explain?                    Yes-No serious adverse drug reaction/event-unknown-◇ refers to one of the following circumstances:-caused death ① ② teratogenic, carcinogenic, cause birth defects-three parts, danger to life and can cause permanent or significant disability       -Black-permanent damage to organs function-II result in hospitalization or longer hospital stays-◇ encoding rules: provinces (autonomous regions and municipalities) city (area) counties (districts) unit serial number         -------------------Note: provinces (autonomous regions and municipalities), municipal (district), County (district) encoded by People's Republic of China administrative division code to fill in.         Units encoding the first bit below fill in: military hospital medical institutions 1, 2, 3 4, production enterprises, family planning agencies, business enterprises 5.    Fill individual reporting unit code 6000 • Note: generic name column, be imported for the first time in 5 years with imported varieties * indicate the ________ national adverse drug reaction monitoring Center for adverse drug reaction monitoring center mailing address: chongwen method in South China, 11th floor address: zip code: 100061 PS Words: (010) Tel: 67164979 fax: (010) 67184951 fax: E-mail:report@adr.gov.cn E-mail:--------------new, serious cases of adverse drug reaction/event reporting requirements for pharmaceutical production enterprises Industry report requirements 1. filled drug bad reaction/event report table; 2. products quality test report; 3. drug manual (imports drug also must submitted abroad drug manual); 4. products registered, and again registered time, whether in monitoring period within (imports drug whether for first allowed imports 5 years within); 5. products State (whether is national basic drug, and national non-prescription drug, and national medical insurance drug, and medicine protection varieties); 6. domestic Shang annual of sales and sales range; 7. outside using situation (package       Including countries of registration and the registration time) 8. changes (components or prescription medicines, production process, quality standards, specification changes); 9. clinical safety studies and literature at home and abroad, 10. Apart from the 1th, 2 other projects within one year if there are no changes, to make.     Annex 2: report: 1) other relevant information requested by drug adverse reaction/event reporting requirements a separate page group report; 2) Please fill in the typical cases of adverse drug reaction/event reporting form; 3) adverse drug reaction/event result means healing, improved, sequelae or death. Drug groups bad reaction/event report requirements a, and medical health institutions report requirements: 1. event description ① occurred time II locations ③ involved drug name II drug bad reaction/event main performance ⑤ diagnosis and treatment process ⑥ turned return situation sadly in the area whether for plans within immune drug 2. typical cases detailed fill in drug bad reaction/event report table 3. report people and the contact phone II, and drug production enterprise reported Told requirements: 1. event occurred, and development, and processing, related situation 2. drug manual (imports drug must provides abroad manual) 3. quality test report 4. whether in monitoring period within (imports drug whether for first allowed imports five years within) 5. registered, and again registered time 6. drug production documents 7. implementation standard 8. both at home and abroad drug security sex research situation, and both at home and abroad drug bad reaction occurred situation including literature reported 9. typical cases detailed fill in drug bad reaction/event reported  Told table 10. report people and the contact phone three, and province, and autonomous regions, and municipalities drug bad reaction monitoring Center report requirements 1. Organization fill in drug groups bad reaction/event report table 2. finishing, and analysis received material 3. proposed associated sex evaluation views 4. close concern event follow-up development 5. event process detailed survey report (event occurred, and development, and processing, and results,) Schedule 3 _____________