Adverse drug reaction reporting and monitoring management
(May 4, 2011, the Ministry of health published come into force July 1, 2011, 81st) Chapter I General provisions
First to strengthen the drug post-marketing monitoring, regulating adverse drug reaction reporting and monitoring, timely and effective control of drug risks, protection of public safety, according to the People's Republic of China drug management law and other relevant laws and regulations, these measures are formulated.
Article in the People's Republic of China territory of adverse drug reaction reporting, monitoring, and supervision and management, application of this approach. Adverse drug reaction reporting systems in third countries.
Pharmaceutical producing enterprises (including foreign pharmaceutical manufacturers of imported drugs), drug-handling enterprises and medical institutions shall, in accordance with the provisions found in the report on adverse drug reactions. Fourth, the State food and drug administration competent national adverse drug reaction reporting and monitoring, local pharmaceutical supervisory and administrative departments at all levels within the administrative area of the adverse drug reaction reporting and monitoring.
Health administrative departments at all levels responsible for the administration of medical institutions with regard to the implementation of the adverse drug reaction reporting system management.
Local drug supervision and management departments at all levels should establish and improve ADR monitoring institutions, responsible for the administration of adverse drug reaction reporting and monitoring of technical work.
Fifth State encourages citizens, legal persons and other organizations to report adverse drug reactions.
Chapter II responsibilities
Sixth the State food and Drug Administration is responsible for national adverse drug reaction reporting and monitoring of management, and perform the following main duties:
(A) developed jointly with the Ministry of health in adverse drug reaction reporting and monitoring of regulations and policies, and supervise their implementation;
(B) jointly with the Ministry of Health organized a nationwide influence of adverse events and serious consequences of drug groups investigating and handling, and publishing relevant information;
(C) has confirmed a serious adverse drug reaction adverse event or drug groups drug to take emergency control measures, make a decision of administrative handling, and to the public;
(D) inform the national adverse drug reaction reporting and monitoring;
(E) the organization check drug production and management enterprises of adverse drug reaction reporting and monitoring of implementation, and organized jointly with the Ministry of health to check medical institutions in adverse drug reaction reporting and monitoring of the situation.
Seventh of provinces, autonomous regions and municipalities within the pharmaceutical supervisory and administrative department responsible for the administration of adverse drug reaction reporting and monitoring of management, and perform the following main duties:
(A) in accordance with the measures and health administrative departments at the same level within their respective administrative areas of adverse drug reaction reporting and monitoring regulations, and supervise their implementation;
(B) jointly with the public health administrative departments at organizations within the administrative area of effect of large groups of drug adverse event investigation and treatment, and publishing relevant information;
(C) has confirmed a serious adverse drug reaction adverse event or drug groups drug to take emergency control measures, make a decision of administrative handling, and to the public;
(D) inform the adverse drug reaction reporting and monitoring within their respective administrative areas;
(E) the Organization checks within the administrative area of drug production, trading enterprises and monitoring of adverse drug reaction reports, and organizations check the Administration jointly with the health administrative departments at medical institutions in adverse drug reaction reporting and monitoring of implementation;
(Vi) organization within the administrative area of the adverse drug reaction reporting and monitoring of advocacy and training work.
Eighth District of municipal and County within the pharmaceutical supervisory and administrative department responsible for the administration of adverse drug reaction reports and monitoring management; organized jointly with the health administrative departments at pharmaceutical group investigation of adverse events that occurred in the administrative areas, and to take the necessary control measures organizations within their respective administrative areas of adverse drug reaction reporting and monitoring of advocacy and training work.
Nineth health administrative departments at and above the county level shall strengthen the supervision and management of clinical drug use in medical institutions, within the areas of responsibility in accordance with the confirmed serious adverse drug reaction adverse event or drug groups to take emergency control measures.
Tenth National adverse drug reaction monitoring centre is responsible for the national adverse drug reaction reporting and monitoring of the technical work, and perform the following main duties:
(A) undertake national adverse drug reaction reporting and monitoring data collection, evaluation, feedback, and reporting, as well as national adverse drug reaction monitoring information network construction and maintenance;
(B) develop adverse drug reaction reporting and monitoring of the technical standards and specifications, technical guidance on local levels, adverse drug reaction monitoring bodies;
(C) organizations to carry out investigation and evaluation of serious adverse drug reactions, drug groups assist the relevant departments investigation of adverse events;
(D) issue warnings of adverse drug reaction;
(E) bear the adverse drug reaction reporting and monitoring of information, training, research and international exchange.
11th provincial adverse drug reactions monitoring body responsible for the administration of adverse drug reaction reporting and monitoring of the technical work, and perform the following main duties:
(A) undertake within their respective administrative areas of adverse drug reaction reports and monitoring data collection, evaluation, feedback, and reporting, as well as adverse drug reaction monitoring information network maintenance and management;
(Ii) the district municipal, County agency guidance for ADR monitoring;
(C) serious adverse drug reactions within the administrative areas of the Organization's investigation and evaluation to assist groups of related departments and drug investigation of adverse events;
(D) organization within the administrative area of the adverse drug reaction reporting and monitoring of advocacy and training work.
12th District of municipal and County monitoring of adverse drug reaction within the institutions responsible for the administration of adverse drug reaction reports and monitoring data collection, validation, evaluation, feedback and reporting; the serious adverse drug reactions within the administrative area of the survey and evaluation assist groups of related departments and drug adverse event survey; take on adverse drug reaction reporting and monitoring of information, training, and so on. 13th of drug production, trading enterprises and medical institutions shall establish reporting and monitoring of adverse drug reaction management system.
Pharmaceutical producing enterprises shall establish an organization and equip fulltime staff, drug distributors and medical institutions shall set up or designate agencies and designed (and) staff, take the adverse drug reaction reporting and monitoring.
14th engaged in adverse drug reaction reporting and monitoring staff should have in medicine, pharmacy, epidemiology and statistics related knowledge, have the ability to analysis of adverse drug reactions.
Chapter III report and disposal
First basic requirements
15th of drug production, trading enterprises and medical organizations known or possible drug-related adverse reactions, should be reported through the national adverse drug reaction monitoring information network; does not have online reporting requirements should be by paper reports report the adverse drug reaction monitoring bodies, the local online reports of adverse drug reactions monitoring bodies.
Report should be true, complete and accurate.
16th levels of ADR monitoring institutions shall, within their respective administrative areas of adverse drug reaction reporting and monitoring evaluation and management information.
17th of drug production, trading enterprises and medical institutions shall cooperate with the pharmaceutical supervisory and administrative departments, health administration, and adverse drug reactions monitoring bodies on adverse drug reactions or group investigation of adverse events, and to provide information necessary for the investigation.
18th of drug production, trading enterprises and medical institutions shall establish and maintain monitoring of adverse drug reaction reports and files.
Section II cases of adverse drug reactions
19th of drug production, trading enterprises and medical institutions shall actively collect ADR, informed or discovers after adverse drug reactions should be recorded, analyzed and processed in detail, fill out the adverse drug reaction/event reporting form (see attachment 1) and report.
20th new drugs made during the monitoring period shall report all the drug's adverse drug reaction; other domestic drug, reports of new and serious adverse reactions.
Imported drugs from first time within 5 years from the date of import, report all adverse reactions of the imported drugs; less than 5 years, reports of new and serious adverse reactions. 21st of drug production, trading enterprises and medical organizations found or learned new and serious adverse drug reactions should be reported in the 15th, which death shall immediately report adverse drug reactions should be reported in the 30th.
Follow-up information, shall promptly report.
22nd drug manufacturers should be informed of investigations into the deaths which details the deaths of basic information, drug usage, side effects and treatment, and completed in the 15th survey report, provincial, where the drug manufacturer adverse drug reactions monitoring body.
23rd individuals discover new or serious adverse drug reactions, can report to Tsuneharu physician, can contribute to the production and management enterprises or local monitoring of adverse drug reaction reports and, if necessary, provide relevant medical information. 24th district of municipal and County ADR adverse drug reaction reports received by the monitoring body should be the authenticity, completeness and accuracy are audited.
Serious adverse drug reaction reports audit and evaluation should be completed within 3 working days from the date of receipt of the report, other reports audit and evaluation should be completed within 15 working days.
District municipal and County of adverse drug reactions monitoring body should be to investigate the deaths, deaths from detailed understanding of basic information, drug usage, side effects and treatment, within 15 working days from the receipt of the report of investigation reports, peer drug regulatory Department and the Administrative Department of public health, as well as adverse drug reactions monitoring bodies at a higher level.
25th provincial adverse drug reaction monitoring Office shall receive the next level of adverse drug reactions serious adverse drug reactions monitoring bodies evaluation completed within 7 working days from the date of assessment.
Deaths occur and pharmaceutical production enterprises are located in provincial adverse drug reactions monitoring institutions shall, according to the survey report analyzing, evaluating and, if necessary, to conduct on-site investigations, and the results reported to the provincial drug supervision and Management Department and the Administrative Department of public health, and the National Center for adverse drug reaction monitoring.
26th National Center for adverse drug reaction monitoring should be death cases in a timely manner to analyze, evaluate, and report the evaluation results to the State food and drug administration and the Ministry of health.
Section III drug adverse events group
27th article drug production, and business enterprise and medical institutions informed or found drug groups bad event Hou, should immediately through phone or fax, way reported location of County drug supervision management sector, and health administrative sector and drug bad reaction monitoring institutions, necessary Shi can leapfrog report; while fill in drug groups bad event basic information table (see schedule 2), on each cases also should timely fill in drug bad reaction/event report table, through national drug bad reaction monitoring information network report.
28th district of municipal and County drugs supervision and management departments informed of adverse events after the drug groups, should be immediate field investigation carried out jointly with the public health administrative departments at organizations and progressive survey results reported in a timely manner to the provincial drug supervision and Management Department and the Administrative Department of public health.
The provincial drug supervision and management jointly with the public health administrative departments at the district level, county-level investigation of the supervision, guidance, analysis, assessment of adverse event drug groups, within the administrative area of effect of large groups of drug adverse events should also be organized on-site investigations, evaluation findings and shall report to the State food and drug administration and the Ministry of health.
Effect and cause serious consequences to the country groups of drug adverse events, the State food and Drug Administration should be carried out jointly with the Ministry of health-related investigations. 29th article drug production enterprise informed drug groups bad event Hou should immediately carried out survey, detailed understand drug groups bad event of occurred, and drug using, and patients diagnosis and treatment and drug production, and store, and circulation, and past similar bad event, situation, in 7th within completed survey report, reported location provincial drug supervision management sector and drug bad reaction monitoring institutions; while quickly carried out self-examination, analysis event occurred of reasons, necessary Shi should suspended production, and sales, and using and recalled related drug,
And reported to the provincial drug supervision and Administration Department.
30th drug-handling enterprises found adverse events and drug groups should inform the manufacturer immediately and quickly carry out self-examination and, when necessary, suspension of the drug's sales, and assist the drug manufacturers to take control measures.
31st medical institutions found that pharmaceutical groups should be active after treatment in patients with adverse events, rapid clinical investigation and analysis of causes of the incident and, if necessary, to take emergency measures such as suspension of drug use. Article 32nd pharmaceutical supervisory and administrative departments can adopt moratoriums on the production, sale, use or recall of drug control measures.
Administrative departments for public health shall take measures to actively organize treatment of patients.
Outside the territory of the fourth section of serious adverse drug reactions Article 33rd imported medicines and drugs made in China in foreign serious adverse drug reactions (including spontaneous reporting system to collect, and post-marketing clinical study, reported in the literature), drug manufacturers should fill out the foreign adverse drug reaction/event reporting form (see schedule 3), from the date it was informed in the 30th to submit National Center for adverse drug reaction monitoring.
National Center for adverse drug reaction monitoring requests for the original report and related information, pharmaceutical producing enterprises shall submit within the 5th.
The 34th National Center for adverse drug reaction monitoring of adverse drug reaction reports received should be analyzed and evaluated, every six months to report to the State food and drug administration and the Ministry of health, findings suggest that drugs could potentially unsafe information should timely report.
The 35th article import drugs and domestic drug was suspended because of adverse drug reactions outside sales, use or removed from the market, drug manufacturers should be informed in writing, within 24 hours after the State food and drug administration and the National Center for adverse drug reaction monitoring.
Fifth periodic safety update reports 36th pharmaceutical producing enterprises shall for the production of drug adverse reactions reporting and monitoring data were collected and analyzed on a regular basis, collecting security information at home and abroad, risk and benefit assessment, write periodic safety update reports.
Periodic safety update report writing specifications developed by the responsible National Center for adverse drug reaction monitoring.
37th established domestic drug monitoring of new drugs, should obtain approval documents every period of 1 year from the date of submission of the periodic safety update report, until the first registration, report once every 5 years; other domestic drug, reported once every 5 years.
First import of medicines, from the date of import drug approval documents made periodic safety update reports every year, until the first registration, report once every 5 years.
Periodic safety update reports summary of drug approval, time to prove the date for the beginning of the file plan, reporting dates should be summarized data within 60 days after the deadline. Periodic safety update report of the 38th China-made medicines to pharmaceutical companies when provincial adverse drug reactions monitoring bodies.
Imported drugs (including imported packaged medicines) the periodic safety update reports submitted to the National Center for adverse drug reaction monitoring.
39th provincial adverse drug reactions monitoring bodies should receive periodic safety update reports for compilation, analysis and evaluation, on April 1 of each year for the preceding year periodic safety update reports and statistics and analyse evaluation results are submitted to the provincial drug supervision and management departments and the National Center for adverse drug reaction monitoring.
40th National Center for adverse drug reaction monitoring should receive periodic safety update reports for compilation, analysis and evaluation, and on July 1 of each year for the preceding year of domestic medicine and imported drugs of periodic safety update reports and statistics and analysis of evaluation results are submitted to the State food and drug administration and the Ministry of health.
Fourth chapter drug monitoring
41st pharmaceutical producing enterprises shall regularly examine the production of drug safety, drug monitoring period of drugs and medicines imports for the first time in 5 years, should focus on monitoring, and according to the requirements for monitoring data collection, analysis, evaluation and reporting; for the production of other chemicals, should be carried out according to the safety initiative focused on monitoring.
42nd pharmaceutical supervisory and administrative departments at or above the provincial level according to the clinical use and adverse reactions may require drug manufacturers to focus on a particular drug monitoring, if necessary, can also be directly adverse drug reaction monitoring agencies, medical institutions and research institutes to carry out drug monitoring.
43rd or above the provincial level adverse drug reactions monitoring body responsible for drug production enterprises focus on monitoring monitoring, inspection, and technical evaluation of the monitoring report.
44th pharmaceutical supervisory and administrative departments at or above the provincial level may joint health administrative departments at designated medical institutions as monitoring points, take on drugs focused on monitoring.
The fifth chapter evaluation and control
45th pharmaceutical producing enterprises shall collect adverse drug reaction reporting and data analysis, evaluation, and take the initiative to conduct drug safety studies. Drug manufacturers have confirmed serious adverse reactions of drugs, through a variety of effective ways of adverse drug reactions and rational drug use information to inform medical staff, patients and the general public; modify the label and description, a moratorium on the production, sales, use, and recall measures, reducing and preventing adverse drug reactions occur.
On the adverse reactions of drugs, should take the initiative to apply for cancellation of the approval documents.
Pharmaceutical producing enterprises shall drug safety information and the measures taken by the provincial drug supervision and management departments and the State food and drug administration.
46th drug-handling enterprises and medical organizations should be collected on adverse drug reaction reporting and monitoring data analysis and evaluation, and to take effective measures to reduce and prevent the recurrence of adverse drug reactions.
47th provincial adverse drug reactions monitoring bodies should be a quarterly comprehensive analysis of adverse drug reaction reports received, extract security information that need your attention, and evaluate proposed risk management, timely reports for the provincial drug supervision and management, health administration and the National Center for adverse drug reaction monitoring.
The provincial drug supervision and management departments according to the evaluation results, to adopt moratoria on the production, sale, use, and recall measures such as drugs, and supervision and inspection, and will be informed of the measures taken at the Administrative Department of public health.
48th National Center for adverse drug reaction monitoring should be on serious adverse drug reaction reports received every quarter for comprehensive analysis of extract security information that need your attention, and evaluate proposed risk management proposals, report to the State food and drug administration and the Ministry of health. 49th State food and drug administration based on the analysis and evaluation of drug results, can require companies to carry out drug safety and effectiveness research.
If necessary, ordered to modify the drug should be taken, a moratorium on the production, sale, use, and recall measures such as drugs, adverse reactions and drug, drug approval documents shall be dismissed and related measures to the Ministry of health.
50th or above the provincial level adverse drug reactions monitoring bodies based on the analysis and evaluation of work, may require the production, trading enterprises and medical organizations to provide relevant information, the relevant units shall cooperate actively.
Sixth chapter information management
51st levels of adverse drug reactions monitoring bodies should receive adverse drug reaction reporting and monitoring data were collected and analyzed, and feedback as appropriate.
52nd National Center for adverse drug reaction monitoring should be based on adverse drug reaction reporting and comprehensive analysis and evaluation of the results of the monitoring data, issue timely warnings of adverse drug reaction.
53rd pharmaceutical supervisory and administrative departments at or above the provincial level should be regularly published adverse drug reaction reporting and monitoring.
The 54th following information published centrally by the State food and drug administration and the Ministry of health:
(A) groups of great impact and serious consequences of drug adverse events;
(B) other important adverse drug reaction information posted as information and need to be harmonized.
Unified information published in the preceding paragraph, the State food and drug administration and the Ministry of health may authorize the provincial drug supervision and Management Department and the Administrative Department of public health.
55th in adverse drug reaction reporting and monitoring process to obtain trade secrets, personal privacy, patient and report information should be kept confidential.
56th to encourage health institutions, pharmaceutical manufacturers, drug-handling enterprises sharing information about adverse drug reactions.
57th of adverse drug reaction reports and statistical information is the basis for strengthening drug administration, guide rational drug use.
The seventh chapter legal liability
58th pharmaceutical producing enterprises, one of the following circumstances, the local drug supervision and management departments to give warning, rectification, and a fine of 5,000 yuan and 30,000 yuan the following:
(A) failing to establish drug adverse reaction reporting and monitoring system, or without specialized, full-time staff of the adverse drug reaction reporting and monitoring;
(B) failure to set up and store files for ADR monitoring;
(C) is not in accordance with the requirements of adverse drug reactions or groups, adverse event reporting, investigation, evaluation and treatment;
(D) is not in accordance with the requirement of submission of periodic safety update reports;
(E) focus was not carried out in accordance with the requirements of monitoring;
(Vi) do not meet serious adverse drug reaction adverse event or groups of the related investigations;
(VII) other violations of these rules.
Drug manufacturers have prescribed in the preceding paragraph, paragraph (d), (e) circumstances, in accordance with the registration provisions of the measures for the administration of the drug is not registered again.
59th drug distributor has any of the following circumstances, the local drug supervision and management departments to give warning, rectification; fails to change, fined not more than RMB 30,000 Yuan:
(A) no full-time or part-time officer in charge of the monitoring of adverse drug reactions;
(B) is not in accordance with the requirements of adverse drug reactions or groups, adverse event reporting, investigation, evaluation and treatment;
(C) does not meet the serious adverse drug reaction adverse event or groups of the related investigations. 60th medical institution has any of the following circumstances, the local health administration department granting warning, rectification; fails to change, fined not more than RMB 30,000 yuan.
Serious and the consequences are serious, local health administrative departments responsible administrative sanctions:
(A) no full-time or part-time officer in charge of the monitoring of adverse drug reactions;
(B) is not in accordance with the requirements of adverse drug reactions or groups, adverse event reporting, investigation, evaluation and treatment;
(C) does not cooperate with groups of serious adverse drug reactions and adverse events of the related investigations.
Pharmaceutical supervisory and administrative departments discovered medical establishment is one of the acts specified in the preceding paragraph, shall be handed over to the health administrative departments at processing.
Administrative Department of public health administrative punishment decision on medical institutions shall promptly inform the pharmaceutical supervisory and administrative departments at the same level.
61st pharmaceutical supervisory and administrative departments at all levels, health administration and adverse drug reactions monitoring institutions and their relevant staff in adverse drug reaction reporting and monitoring in the management of violating these rules, resulting in serious consequences, in accordance with the relevant provisions of administrative sanctions.
62nd of drug production, trading enterprises and medical organizations in violation of the relevant provisions, causing damage to drug users shall bear the liability.
The eighth chapter supplementary articles
The 63rd the following terms shall have the meanings herein:
(A) of ADR, under normal usage, refers to the qualified drug appeared unrelated to the drug adverse reactions.
(B) the reporting and monitoring of adverse drug reaction, refers to the adverse drug reactions of discovery, reporting, evaluation and control of the process.
(C) serious adverse drug reaction, refers to using one of the following damage caused by drug reactions:
1. lead to death;
2. life-threatening;
3. carcinogenic, teratogenic, cause birth defects;
4. lead to significant or permanent disability of the human body or organ damage;
5. hospital or hospital stay extended;
6. other important medical events listed above may occur if treatment is not carried out. (D) the new ADR refers to drug adverse reactions that are not set out in the specifications.
Are described in the specifications, but the nature and extent of adverse reactions, consequences or frequency inconsistent with the specification describes or, more seriously, in accordance with the new adverse drug reactions.
(E) adverse event drug groups, is the same drug used in the process, in a relatively concentrated period of time, regional, on a number of population health or result in damage or threat to the security of life, need to be emergency events.
The same medicine: refers to the same production of the same name, same formulations, same specifications of medicines.
(F) drug monitoring refers to further understand the clinical use and ADR of the drugs, study characteristics, severity, incidence of adverse reactions, drug safety monitoring activities carried out.
64th overseas pharmaceutical manufacturers of imported drugs can delegate its China offices or agencies in China, in accordance with the provisions of the present approach to drug manufacturers and comply with adverse drug reaction reporting and monitoring obligations.
65th on the Ministry of health and the State food and Drug Administration vaccine adverse reaction reporting and monitoring provides otherwise, from its provisions.
66th medical preparations of adverse reaction reporting and monitoring of the measures for the administration of all provinces, autonomous regions and municipalities directly under the pharmaceutical supervisory and administrative departments of public health Administrative Department. 67th these measures come into force July 1, 2011.
The State food and drug administration and the Ministry of Health announced on March 4, 2004, adverse drug reaction reporting and monitoring Regulation (State food and drug administration, 7th) repealed simultaneously.
Schedule: 1. adverse drug reaction/event reporting form
2. groups of adverse event information table 3. overseas adverse drug reaction/event reporting form Appendix 1: adverse drug reaction/event report form report for the first time-tracker-codes: ____________________________________
Report type: new-serious category-General-reporting units: medical institutions-business-business-personal-other-___________
┌─────────┬───────┬─────────────┬─────┬────────┬────────────┐
│ Patient name: │ gender: male-female-│ date of birth: year month day │ nation: │ weight (kg): │ contact │
│ │ │或年龄： │ │ │ │
├─────────┴───┬───┴─────────────┼─────┴────────┴────────────┤
│ The disease: │ hospital name: │ past adverse drug reactions/events:-none-unknown-│
│ │/Medical records, clinic number: │ family of adverse drug reactions/events:-none-unknown-│
├─────────────┴─────────────────┴───────────────────────────┤
│ Important information: smoking-alcohol consumption-history of pregnancy-history of liver diseases-kidney diseases-allergy-other-________________ ________________ │
├─┬────┬────┬───────┬───────────┬────┬─────────┬───────┬────┤
│ │ Product │ │ drug approval number lot number manufacturer generic name │ │ │ dosage (dose, duration │ │ medication medication causes │
│品│ │ │ （含剂型） │ │ │ 途径、日次数） │ │ │
├─┼────┼────┼───────┼───────────┼────┼─────────┼───────┼────┤
│怀│ │ │ │ │ │ │ │ │
│疑├────┼────┼───────┼───────────┼────┼─────────┼───────┼────┤
│药│ │ │ │ │ │ │ │ │
│品├────┼────┼───────┼───────────┼────┼─────────┼───────┼────┤
│ │ │ │ │ │ │ │ │ │
├─┼────┼────┼───────┼───────────┼────┼─────────┼───────┼────┤
│并│ │ │ │ │ │ │ │ │
│用├────┼────┼───────┼───────────┼────┼─────────┼───────┼────┤
│药│ │ │ │ │ │ │ │ │
│品├────┼────┼───────┼───────────┼────┼─────────┼───────┼────┤
│ │ │ │ │ │ │ │ │ │
├─┴────┴────┴───────┴─────────┬─┴────┴─────────┴───────┴────┤
│ Adverse reactions/events name: │ adverse reactions/events: date │
├─────────────────────────────┴─────────────────────────────┤
│ Adverse drug reaction/event descriptions (including symptoms, signs, and clinical laboratory, etc) and processed (Supplement): │
│ │
│ │
│ │
│ │
│ │
│ │
│ │
├───────────────────────────────────────────────────────────┤
│ Adverse reaction/event outcomes: cure-better-no improvement-unknown-legacy-performance: ___________________________ │
│ 死亡□ 直接死因：_________________________ 死亡时间： 年 月 日 │
├───────────────────────────────────────────────────────────┤ │ After discontinuation or reduction, whether the reaction/event disappeared or decreased?
Yes-No-unknown-do not stop or reduction-¦ │ Suspected drug is used again after a recurrence of the same reaction/event?
是□ 否□ 不明□ 未再使用□ │
├───────────────────────────────────────────────────────────┤
│ The original disease impact: not obvious-sequel-duration-ill-led death-│
├───────┬───────────────────────────────────────────────────┤
│ │ Relevance evaluation reports evaluation:-may-may-may-independent-reviews-to evaluate-signature: │
│ │ Report evaluation unit:-may-may-may-independent-reviews-to evaluate-signature: │
├───────┼──────────────────┬────────────────────────────────┤
│ Speakers │ Tel: │ Careers: physician-pharmacist-nurse-other-___________________ │
│ ├──────────────────┴────────┬───────────────────────┤
│ │电子邮箱： │签名： │
├───────┼────────────┬──────────────┼──────────┬────────────┤
│ │ Report name: │ contact │ Tel: │ date: year month day │
├───────┼────────────┴──────────────┴──────────┴────────────┤
│ Company │ medical institutions-business-business-personal-that reported post-marketing studies-other-________________________ │
│ 填写信息来源 │ │
├───────┼───────────────────────────────────────────────────┤
│ 备 注 │ │
└───────┴───────────────────────────────────────────────────┘
Serious adverse drug reaction, refers to using one of the following damage caused by drug reactions:
1) resulting in death;
2) life-threatening;
3) carcinogenic, teratogenic, cause birth defects;
4) resulted in significant or permanent disability of the human body or organ damage;
5) leads to hospitalization or hospital stay extended;
6) lead to other important medical events, such as untreated conditions listed above may occur. New ADR: refers to drug adverse reactions that are not set out in the specifications.
Are described in the specifications, but the nature and extent of adverse reactions, consequences or frequency inconsistent with the specification describes or, more seriously, in accordance with the new adverse drug reactions.
Reporting time New and serious adverse drug reactions should be discovered or known date of 15th report, death shall immediately report adverse drug reaction reports in the 30th.
Follow-up information, shall promptly report.
Additional instructions
Suspected drug: refers to the use of suspected adverse reactions related to the drug.
Drugs: that this adverse drug reaction occurs patients, suspected drugs, other medications, including PCI in patients with medicines or herbs, and so on.
Usage and dosage: including dosage, route of administration, the number of daily administration, for example, 5mg, oral, 2 times daily.
Report processing All the reports into databases, professional staff will analyze the relationship between the drug and the adverse reaction/event. According to the universality of drug risk or severity, determine the need for measures, such as adding warnings to drug, update information on the safe use of medicines.
In rare cases, when you think risks outweigh the benefits of the drug, medicine will be removed from the market.
Table 2: the adverse event profile of drug groups table
┌───────────────┬──────────────┬───────────────┐
│发生地区： │使用单位： │用药人数： │
├───────────────┼──────────────┼───────────────┤
│ Number of adverse events: │ number of serious adverse events: │ deaths: │
├───────────────┴─────┬────────┴───────────────┤
│ First medication date: year month day │ date first: date │
├──┬────┬───────┬─────┴─────┬─────┬─────┬──────┤
Common name │ about us │ products │ │ company │ │ a │ production batch drug specifications approval number │
│ ├────┼───────┼───────────┼─────┼─────┼──────┤
│ │ │ │ │ │ │ │
│ ├────┼───────┼───────────┼─────┼─────┼──────┤
│怀 │ │ │ │ │ │ │
│疑 ├────┼───────┼───────────┼─────┼─────┼──────┤
│药 │ │ │ │ │ │ │
│品 ├────┼───────┼───────────┼─────┼─────┼──────┤
│ │ │ │ │ │ │ │
│ ├────┼───────┼───────────┼─────┼─────┼──────┤
│ │ │ │ │ │ │ │
│ ├────┼───────┼───────────┼─────┼─────┼──────┤
│ │ │ │ │ │ │ │
├──┼────┴───────┼───────────┼─────┴──┬──┴──────┤
│ │ 产品名称 │ 生产企业 │ 生产批号 │ 注册号 │
│ ├────────────┼───────────┼────────┼─────────┤
│ 器 │ │ │ │ │
│ 械 ├────────────┼───────────┼────────┼─────────┤
│ │ │ │ │ │
│ ├────────────┴───────────┴────────┴─────────┤ │ │ This device was suspected drug use and may be associated with adverse events of groups of medical equipment such as syringes, infusion.
│
├──┴───────────────────────────────────────────┤
│不良事件表现： │
├──────────────────────────────────────────────┤
│ Group process description and treatment of adverse events (Supplement): │
│ │
│ │
│ │
│ │
│ │
│ │
│ │
│ │
├───────┬──────────────────────────────────────┤
│报告单位意见 │ │
│ │ │
├───────┼──────────────────────────────────────┤
│报告人信息 │电话： 电子邮箱： 签名： │
├───────┼──────────────────────────────────────┤
│报告单位信息 │报告单位： 联系人： 电话： │
└───────┴──────────────────────────────────────┘
Report date: year month day Table 3: foreign adverse drug reaction/event reporting form
Brand name: (English: English:), generic name: (English: English:) dosage form:
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¦ Number ¦ adverse side effects/adverse reaction/│ │ back │ drugs beginning knot uses │ │ │ medication drugs cause initial/gender age │ │ │ │ │ │ domestic report received │ comments │
Name │ │ events │ │ │ │ │ │││││ beam time tracking report results from date │ country │ │ │
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Note: the numbers please complete this unit number; adverse results, please fill in: healing, improving, not improved, sequelae, unknown or of death; the source please fill in: spontaneous reports, research, documentation, and so on. 报告单位： 联系人： 电话： 报告日期：
