Management of Adverse Drug Reaction Reporting and Monitoring

Chapter I General Provisions  

Article 1 These Measures are formulated in accordance with the Drug Administration Law of the People's Republic of China and other relevant laws and regulations for the purpose of strengthening the post-marketing supervision of drugs, standardising the reporting and monitoring of adverse drug reactions, controlling the risks of drugs in a timely and effective manner, and safeguarding the safety of drugs for public use.

Article 2 These Measures shall apply to the reporting, monitoring, supervision and management of adverse drug reactions within the territory of the People's Republic of China.

Article 3 The State implements the adverse drug reaction reporting system. Drug manufacturers (including imported drugs overseas pharmaceutical manufacturers), drug companies, medical institutions should be in accordance with the provisions of the adverse drug reaction report found.

Article 4 The State Food and Drug Administration shall be in charge of the national adverse drug reaction reporting and monitoring work, and the local drug supervision and management departments at all levels shall be in charge of the adverse drug reaction reporting and monitoring work in their own administrative areas. Health administrative departments at all levels are responsible for the implementation of adverse drug reaction reporting system in the administrative area of medical institutions and the management of the system.

The local drug supervision and management departments at all levels shall establish and improve the monitoring organisation of adverse drug reactions, and shall be responsible for the technical work of reporting and monitoring of adverse drug reactions in the administrative area.

Article 5 The state encourages citizens, legal persons and other organisations to report adverse drug reactions.

Chapter II Responsibilities

Article 6 The State Food and Drug Administration is responsible for the management of the national adverse drug reaction reporting and monitoring, and to fulfil the following main responsibilities:

(A) and the Ministry of Health to jointly formulate the adverse drug reaction reporting and monitoring of management regulations and policies, and supervise the implementation;

(ii) To jointly organise with the Ministry of Health the investigation and handling of group adverse drug events with large impact and serious consequences nationwide, and to release relevant information;

(C) To take emergency control measures in accordance with the law for medicines for which serious adverse drug reactions or adverse drug group events have been confirmed to have occurred, to make administrative treatment decisions, and to make them known to the public;

(D) To notify the nation of the reporting and monitoring of adverse drug reactions;

(E) organise inspections of drug manufacturers and business enterprises to report and monitor adverse drug reactions, and jointly organise with the Ministry of Health inspections of medical institutions to report and monitor adverse drug reactions.

Article 7 The drug supervision and management departments of provinces, autonomous regions and municipalities directly under the central government shall be responsible for the management of the reporting and monitoring of adverse drug reactions in the administrative regions and shall perform the following major duties:

(A) in accordance with these Measures and the health administrative department at the same level to formulate the administrative regulations for the reporting and monitoring of adverse drug reactions in the administrative area, and supervise the implementation;

(ii) To jointly organise with the administrative department of health at the same level the investigation and handling of group adverse drug events of greater impact occurring in the administrative region, and to release relevant information;

(C) has confirmed the occurrence of serious adverse drug reactions or drug group adverse events of drugs in accordance with the law to take emergency control measures, make administrative treatment decisions, and to the public;

(D) To inform the reporting and monitoring of adverse drug reactions in the administrative region;

(E) organise the inspection of the administrative region of the drug production, management enterprises of adverse drug reaction reporting and monitoring work carried out, and with the same level of health administrative departments jointly organise the inspection of the administrative region of the medical institutions of adverse drug reaction reporting and monitoring work carried out;

(F) organise and carry out the publicity and training work of adverse drug reaction reporting and monitoring in the administrative region.

Article VIII municipal and county-level drug supervision and management departments are responsible for the administrative region of the adverse drug reaction reporting and monitoring of management; with the same level of health administrative departments to jointly organise and carry out the administrative region of the occurrence of adverse events of groups of medicines investigation, and to take the necessary control measures; organise and carry out the administrative region of the adverse drug reaction reporting and monitoring of publicity and training work.

Article 9 The health administrative departments at or above the county level shall strengthen the supervision and management of the clinical use of medicines in medical institutions, and within the scope of their duties, shall take relevant emergency control measures for the confirmed serious adverse drug reactions or adverse drug group events according to law.

Article 10 The National Adverse Drug Reaction Monitoring Centre shall be responsible for the technical work of national adverse drug reaction reporting and monitoring, and shall perform the following main duties:

(1) To undertake the collection, evaluation, feedback and reporting of national adverse drug reaction reporting and monitoring information, as well as the construction and maintenance of the national adverse drug reaction monitoring information network;

(ii) To formulate technical standards and norms for the reporting and monitoring of adverse drug reactions, and to provide technical guidance to local agencies for monitoring adverse drug reactions at all levels;

(3) To organise and carry out investigations and evaluations of serious adverse drug reactions, and to assist the relevant departments in carrying out investigations of group adverse drug events;

(D) To issue warning information on adverse drug reactions;

(E) Undertake the publicity, training, research and international exchange of adverse drug reaction reporting and monitoring.

Article 11 The provincial-level adverse drug reaction monitoring organisations are responsible for the technical work of adverse drug reaction reporting and monitoring in the administrative region, and perform the following main duties:

(a) To undertake the collection, evaluation, feedback and reporting of adverse drug reaction reports and monitoring information within the administrative region, as well as the maintenance and management of the adverse drug reaction monitoring information network;

(ii) To provide technical guidance to municipal and county-level adverse drug reaction monitoring organisations in the districts;

(C) To organise and carry out the investigation and evaluation of serious adverse drug reactions in the administrative region, and assist the relevant departments to carry out the investigation of group adverse drug events;

(D) organise and carry out in the administrative region of adverse drug reaction reporting and monitoring of publicity and training.

Article 12 The municipal and county-level adverse drug reaction monitoring organisations are responsible for collecting, verifying, evaluating, feeding back and reporting the adverse drug reaction reports and monitoring information in the administrative area; carrying out the investigation and evaluation of serious adverse drug reactions in the administrative area; assisting the relevant departments to carry out the investigation of group adverse drug events; and undertaking the publicity and training work on the reporting and monitoring of adverse drug reactions.

Article 13 The drug production, management enterprises and medical institutions shall establish the adverse drug reaction reporting and monitoring management system. Drug manufacturers shall set up specialised institutions and full-time personnel, drug business enterprises and medical institutions shall set up or designate institutions and full-time (part-time) personnel to undertake the reporting and monitoring of adverse drug reactions in the unit.

Article 14 The staff engaged in reporting and monitoring of adverse drug reactions shall have relevant professional knowledge in medicine, pharmacy, epidemiology or statistics, and have the ability to scientifically analyse and evaluate adverse drug reactions.

 

Chapter III Reporting and Disposal

Section I. Basic Requirements

Article 15 Drug production, management enterprises and medical institutions shall report through the national adverse drug reaction monitoring information network when they are informed of or discover adverse reactions that may be related to the use of drugs; if they do not have the online reporting conditions, they shall report through paper statements to the local adverse drug reaction monitoring organisations, which shall report online on behalf of the local adverse drug reaction monitoring organisations.

The content of the report shall be true, complete and accurate.

Article 16 The adverse drug reaction monitoring organisations at all levels shall evaluate and manage the adverse drug reaction reports and monitoring information within the administrative area.

Article 17 The drug production, management enterprises and medical institutions shall co-operate with the drug supervision and management departments, health administrative departments and adverse drug reaction monitoring agencies to investigate the adverse drug reactions or group adverse events, and provide the information required for the investigation.

Article 18 The drug manufacturers, business enterprises and medical institutions shall establish and keep files of adverse drug reaction reports and monitoring.

Section II cases of adverse drug reactions

Article 19 Drug manufacturers, business enterprises and medical institutions shall take the initiative to collect adverse drug reactions, and after being informed of or discovering adverse drug reactions, they shall record, analyse and deal with them in detail, and fill in the "Adverse Drug Reaction/Event Report Form" (see Schedule 1) and report them.

Article 20 Domestic medicines within the monitoring period of new medicines shall report all adverse reactions of the medicines; for other domestic medicines, report new and serious adverse reactions.

Imported drugs within five years from the date of first approval for importation, report all adverse reactions of the imported drug; after five years, report new and serious adverse reactions.

Article 21 Drug manufacturers, business enterprises and medical institutions found or were informed of new and serious adverse drug reactions shall be reported within 15 days, of which deaths shall be reported immediately; other adverse drug reactions shall be reported within 30 days. If there is follow-up information, it shall be reported in time.　　

Article 22 The drug manufacturer shall investigate the notified fatal cases, detailed understanding of the basic information of the fatal cases, the use of drugs, adverse reactions and diagnosis and treatment of the situation, and within 15 days to complete the investigation report, reported to the drug manufacturer's location of the provincial level of adverse drug reaction monitoring organisations.

Article 23 The individual found new or serious adverse drug reactions, can be reported to the treating physician, can also be reported to the drug production, management enterprises or the local adverse drug reaction monitoring organisations, if necessary, to provide relevant medical records.

Article 24 The municipal and county-level adverse drug reaction monitoring organisations shall review the authenticity, completeness and accuracy of the adverse drug reaction reports received. The audit and evaluation of serious adverse drug reaction reports shall be completed within 3 working days from the date of receipt of the report, and the audit and evaluation of other reports shall be completed within 15 working days.

The municipal and county-level adverse drug reaction monitoring organisations shall investigate the death cases, understand in detail the basic information of the death cases, the use of drugs, the occurrence of adverse reactions and diagnosis and treatment, etc., and complete the investigation report within 15 working days from the date of receipt of the report, and report it to the same level of drug supervision and management department and the health administrative department, as well as the higher level of the monitoring organisations of adverse drug reactions.

Article 25 The provincial-level adverse drug reaction monitoring organisation shall complete the evaluation within 7 working days from the date of receipt of the evaluation opinion of serious adverse drug reaction submitted by the lower-level adverse drug reaction monitoring organisation.

For fatal cases, both the provincial adverse drug reaction monitoring institutions at the place of occurrence of the incident and the place where the drug manufacturer is located shall promptly analyse and evaluate the case based on the investigation report, conduct on-site investigation if necessary, and report the evaluation results to the provincial drug supervision and management department and the health administrative department, as well as to the National Centre for Adverse Drug Reaction Monitoring.

Article 26 The National Adverse Drug Reaction Monitoring Centre shall analyse and evaluate the death cases in time, and report the evaluation results to the State Food and Drug Administration and the Ministry of Health.

Section III group adverse drug events

Article 27 The drug manufacturers, business enterprises and medical institutions shall immediately report to the county-level drug supervision and management departments, health administrative departments and adverse drug reaction monitoring institutions by telephone or fax after being informed of or discovering the adverse drug group events, and if necessary, may report to the next level; at the same time, fill in the "Basic Information Form on Adverse Drug Group Events" (see Table 2), and each case shall also promptly fill in the "Adverse Drug Reaction/Incident Reporting Centre". Fill in the "Adverse Drug Reaction/Event Report Form", and report through the national adverse drug reaction monitoring information network.

Article 28 The municipal and county-level drug supervision and management departments shall immediately organise on-site investigations jointly with the health administrative departments at the same level after being informed of the group adverse drug events, and promptly report the investigation results to the provincial drug supervision and management departments and health administrative departments at each level.

Provincial drug supervision and management departments and the same level of health administrative departments jointly supervise and guide the investigation at the municipal and county levels, analyse and evaluate the adverse drug group events, and also organize on-site investigations of the more influential adverse drug group events occurring in the administrative region, and the evaluation and investigation results should be reported to the State Food and Drug Administration and the Ministry of Health in a timely manner.

Nationwide impact and cause serious consequences of drug group adverse events, the State Food and Drug Administration shall jointly with the Ministry of Health to carry out related investigations.

Article 29 The drug manufacturer shall carry out investigation immediately after being informed of the drug group adverse events, detailed understanding of the occurrence of the drug group adverse events, drug use, patient treatment, as well as drug production, storage, circulation, past similar adverse events, etc., and complete the investigation report within 7 days, reported to the provincial drug supervision and management department and the adverse drug reaction monitoring agency; and at the same time to carry out a rapid self-examination, analysis At the same time, it shall rapidly carry out self-examination, analyse the reasons for the occurrence of the incident, and if necessary, suspend the production, sale, use and recall of the relevant medicines, and report to the provincial drug supervision and management department at the place where it is located.

Article 30 The drug business enterprises shall immediately inform the drug manufacturers when they discover the adverse events of drug groups, and at the same time carry out self-examination promptly, suspend the sales of drugs if necessary, and assist the drug manufacturers to take relevant control measures.

Article 31 The medical institutions shall actively treat the patients after discovering the group adverse drug events, carry out clinical investigation promptly, analyse the reasons for the events, and suspend the use of drugs and other emergency measures if necessary.

Article 32 The drug supervision and management department may take control measures such as suspending the production, sale, use or recall of drugs. The administrative department of health shall take measures to actively organise the rescue and treatment of patients.

Section IV serious adverse drug reactions occurring outside the country

Article 33 For serious adverse drug reactions (including those collected by spontaneous reporting system, discovered by post-marketing clinical research and reported in the literature) of imported drugs and domestically produced drugs occurring outside the country, drug manufacturers shall fill in the Report Form of Adverse Drug Reactions/Events Occurring Outside the Country (see Exhibit 3), and report them to the National Center for Monitoring Adverse Drug Reactions (NCMR) within 30 days from the date of being informed of the occurrence of adverse drug reactions. If the National Adverse Drug Reaction Monitoring Centre requests for the original report and related information, the drug manufacturer shall submit it within 5 days.

Article 34 The National Adverse Drug Reaction Monitoring Center shall analyse and evaluate the adverse drug reaction reports received, and report to the State Food and Drug Administration and the Ministry of Health every six months, and shall promptly report the information found to suggest that the drugs may have potential safety hazards.

Article 35 The imported drugs and domestic drugs outside the country due to adverse drug reactions were suspended from sale, use or withdrawal of the drug manufacturers should be informed of the State Food and Drug Administration and the State Adverse Drug Reaction Monitoring Centre within 24 hours in writing.

Section V Periodic Safety Update Report

Article 36 The drug manufacturer shall regularly analyse the adverse reaction reports and monitoring data of the drugs produced by the enterprise, summarize the domestic and international safety information, assess the risks and benefits, and write regular safety update reports. The specifications for writing regular safety update reports shall be formulated by the National Centre for Adverse Drug Reaction Monitoring.

Article 37 Domestic medicines for which the monitoring period for new medicines is established shall submit a periodic safety update report every one year from the date of obtaining the approval certificate until the first re-registration, and then every five years thereafter; for other domestically produced medicines, the report shall be submitted every five years.

For drugs imported for the first time, the periodic safety update report shall be submitted every one year from the date of obtaining the approval document for imported drugs until the first re-registration, and then every five years thereafter.

The summary time of the periodic safety update report shall be counted as the starting point from the date of obtaining the document of approval of the drug, and the reporting date shall be within 60 days after the deadline of the summary data.

Article 38 The periodic safety update report of the domestically produced drugs shall be submitted to the provincial-level adverse drug reaction monitoring organ where the drug manufacturer is located. The periodic safety update report of imported drugs (including imported sub-packaged drugs) shall be submitted to the National Adverse Drug Reaction Monitoring Centre.

Article 39 The provincial-level adverse drug reaction monitoring institutions shall summarise, analyse and evaluate the regular safety update reports received, and report the statistics of the regular safety update reports and the results of analysis and evaluation of the previous year to the provincial-level drug supervision and management departments and the National Centre for Adverse Drug Reaction Monitoring before 1 April each year.

Article 40 The National Adverse Drug Reaction Monitoring Centre shall summarize, analyze and evaluate the regular safety update reports received, and report the statistics and analysis and evaluation results of the regular safety update reports of domestic and imported drugs for the previous year to the State Food and Drug Administration and the Ministry of Health before 1 July each year.

 

Chapter IV Key Monitoring of Medicines

Article 41 Drug manufacturers shall frequently examine the safety of the drugs produced by the enterprise, and shall carry out key monitoring of drugs within the monitoring period of new drugs and drugs imported for the first time within 5 years, and shall summarise, analyse, evaluate and report the monitoring data as required; and shall take the initiative to carry out key monitoring of other drugs produced by the enterprise in accordance with the safety situation.

Article 42 The drug supervision and management departments at or above the provincial level, according to the clinical use of drugs and adverse reaction monitoring, can require drug manufacturers to carry out key monitoring of specific drugs; if necessary, can also directly organise the adverse drug reaction monitoring institutions, medical institutions and scientific research units to carry out key monitoring of drugs.

Article 43 The adverse drug reaction monitoring organisations at or above the provincial level are responsible for supervising and inspecting the key monitoring carried out by the drug manufacturers, and conducting technical evaluation of the monitoring reports.

Article 44 The drug supervision and management departments at or above the provincial level can jointly with the health administrative departments at the same level to designate medical institutions as monitoring points to undertake key monitoring of drugs.

Chapter V evaluation and control

Article 45 Drug manufacturers shall analyse and evaluate the collected adverse drug reaction reports and monitoring information, and take the initiative to carry out drug safety research.

Drug manufacturers shall inform medical personnel, patients and the public of adverse drug reactions and information on rational use of drugs in a timely manner through various effective channels for drugs with confirmed serious adverse reactions; and take measures such as modifying labels and specifications, suspending production, sales, use and recall, etc., in order to reduce and prevent the recurrence of adverse drug reactions. For medicines with high adverse reactions, they should take the initiative to apply for cancellation of their approval certification documents.

Drug manufacturers shall report drug safety information and measures taken to the local provincial drug supervision and management departments and the State Food and Drug Administration.

Article 46 The drug business enterprises and medical institutions shall analyse and evaluate the collected adverse drug reaction reports and monitoring information, and take effective measures to reduce and prevent the recurrence of adverse drug reactions.

Article 47 The provincial-level adverse drug reaction monitoring institutions shall conduct a comprehensive analysis of the adverse drug reaction reports received on a quarterly basis, extract the safety information that needs attention, and evaluate it, put forward risk management suggestions, and report it to the provincial-level drug supervision and management department, the administrative department of health, and the National Centre for Adverse Drug Reaction Monitoring in a timely manner.

Based on the results of analysis and evaluation, the provincial drug supervision and management department may take measures such as suspending the production, sale, use and recall of the drugs, and supervise and inspect them, and at the same time notify the health administrative department at the same level of the measures taken.

Article 48 The National Adverse Drug Reaction Monitoring Centre shall conduct a comprehensive analysis of the serious adverse drug reaction reports received on a quarterly basis, extract the safety information that needs to be paid attention to and evaluate it, put forward risk management suggestions, and report them to the State Food and Drug Administration and the Ministry of Health in a timely manner.

Article 49 The State Food and Drug Administration, based on the results of the analysis and evaluation of drugs, may require companies to carry out research related to drug safety and effectiveness. If necessary, it shall take measures such as ordering the modification of drug instructions, suspending the production, sale, use and recall of medicines, and shall revoke the certificate of approval of medicines for medicines with high adverse reactions, and inform the Ministry of Health of the relevant measures in a timely manner.

Article 50 Adverse drug reaction monitoring organisations at or above the provincial level may, according to the needs of analysis and evaluation, require drug manufacturers, business enterprises and medical institutions to provide relevant information, and the relevant units shall actively cooperate.

Chapter VI Information Management

Article 51 The adverse drug reaction monitoring institutions at all levels shall carry out statistics and analyses on the adverse drug reaction reports and monitoring information received, and give feedback in an appropriate form.

Article 52 The National Adverse Drug Reaction Monitoring Centre shall, based on the results of comprehensive analysis and evaluation of the adverse drug reaction reports and monitoring information, timely release of adverse drug reaction warning information.

Article 53 The drug supervision and management departments at or above the provincial level shall regularly issue adverse drug reaction reports and monitoring.

Article 54 The following information shall be released uniformly by the State Food and Drug Administration and the Ministry of Health:

(A) a large impact and cause serious consequences of drug group adverse events;

(B) other important adverse drug reaction information and the need for unified release of information.

The preceding paragraph of the unified release of information, the State Food and Drug Administration and the Ministry of Health may also authorise the provincial drug supervision and management departments and health administrative departments to release.

Article 55 In the process of adverse drug reaction reporting and monitoring of commercial secrets, personal privacy, patient and reporter information shall be kept confidential.

Article 56 encourages the sharing of adverse drug reaction information among medical institutions, drug manufacturers and drug business enterprises.

Article 57 The contents and statistics of adverse drug reaction reports are the basis for strengthening drug supervision and management and guiding the rational use of drugs.

Chapter VII Legal Liability

Article 58 If a drug manufacturer has any of the following circumstances, the local drug supervision and management department shall give a warning and order rectification within a certain period of time, and may also impose a fine of not less than 5,000 yuan and not more than 30,000 yuan:

(A) fails to establish an adverse drug reaction reporting and monitoring management system in accordance with the regulations, or does not have a specialised agency or a full-time employee responsible for the reporting and monitoring of adverse drug reactions in the unit;

(B) Failure to establish and maintain files for monitoring adverse drug reactions;

(C) not in accordance with the requirements of adverse drug reactions or group adverse event reporting, investigation, evaluation and treatment;

(D) Failure to submit regular safety update reports as required;

(E) Failure to carry out key monitoring in accordance with the requirements;

(F) Failure to cooperate with the investigation of serious adverse drug reactions or group adverse events;

(G) Other violations of the provisions of these measures.

If a drug manufacturer has one of the situations stipulated in (4) and (5) of the preceding paragraph, the corresponding drug shall not be re-registered in accordance with the provisions of the Measures for the Administration of Drug Registration.

Article 59 If a drug business enterprise has one of the following circumstances, it shall be given a warning by the local drug supervision and management department and ordered to make corrections within a certain period of time; if it fails to make corrections after the expiration of the period of time, it shall be fined not more than 30,000 yuan:

(A) no full-time or part-time personnel responsible for the unit's adverse drug reaction monitoring work;

(B) not in accordance with the requirements of adverse drug reactions or group adverse event reporting, investigation, evaluation and treatment;

(C) does not cooperate with the serious adverse drug reactions or group adverse events related to the investigation.

Article 60 If a medical institution has one of the following circumstances, the local health administrative department shall give a warning and order rectification within a certain period of time; if it fails to do so, it shall impose a fine of not more than 30,000 yuan. If the situation is serious and causes serious consequences, the local health administrative department shall give administrative sanctions to the relevant responsible person:

(A) no full-time or part-time personnel responsible for the unit of adverse drug reaction monitoring work;

(B) not in accordance with the requirements of adverse drug reactions or group adverse event reporting, investigation, evaluation and treatment;

(C) does not cooperate with the investigation of serious adverse drug reactions and group adverse events.

Drug supervision and management department found that the medical institutions have one of the behaviours stipulated in the preceding paragraph, should be transferred to the same level of health administration department.

Health administrative department of the medical institutions to make administrative penalty decision, shall promptly notify the drug supervision and management department at the same level.

Article 61 The drug supervision and management departments at all levels, health administrative departments and adverse drug reaction monitoring organisations and their relevant staff in the adverse drug reaction reporting and monitoring management in violation of these measures, resulting in serious consequences, shall be given administrative sanctions in accordance with the relevant provisions.

Article 62 If drug manufacturers, business enterprises and medical institutions violate the relevant provisions and cause damage to drug users, they shall bear the responsibility for compensation in accordance with the law.

Chapter VIII Supplementary Provisions

Article 63 The meaning of the following terms in these Measures:

(1) Adverse drug reaction refers to the harmful reaction unrelated to the purpose of medication that occurs under normal usage and dosage of qualified medicines.

(B) Adverse drug reaction reporting and monitoring refers to the process of discovery, reporting, evaluation and control of adverse drug reactions.

(iii) Serious adverse drug reaction means a reaction caused by the use of a drug that results in one of the following damaging situations:

1. causing death;

2. endangering life;

3. Causing cancer, teratogenicity, birth defects;

4. Causing significant or permanent human disability or impairment of organ function;

5. lead to hospitalisation or prolonged hospitalisation;

6. lead to other important medical events, such as the absence of treatment may occur as listed above.

(d) New adverse drug reactions are those that are not contained in the drug's specification. If there is a description in the instruction manual, but the nature, degree, consequence or frequency of the adverse reaction is inconsistent with the description in the instruction manual or is more serious, it shall be treated as a new adverse drug reaction.

(E) drug group adverse events, refers to the same drug in the process of use, in a relatively concentrated time, region, to a certain number of people's physical health or life safety caused by the damage or threat to the event that needs to be dealt with urgently.

The same drug: refers to the same drug name, the same dosage form and the same specification of the same drug produced by the same manufacturer.

(f) Key monitoring of medicines refers to the safety monitoring activities of medicines carried out for the purpose of further understanding the clinical use of medicines and the occurrence of adverse reactions, and studying the characteristics of the occurrence of adverse reactions, their severity and incidence.

Article 64 An overseas pharmaceutical manufacturer that imports drugs may entrust its office in China or its agent in China to fulfil the obligation of reporting and monitoring adverse drug reactions in accordance with the provisions of these Measures for pharmaceutical manufacturers.

Article 65 If the Ministry of Health and the State Food and Drug Administration have other provisions on the reporting and monitoring of adverse reactions to vaccines, such provisions shall apply.

Article 66 The administrative measures for the reporting and monitoring of adverse reactions of preparations in medical institutions shall be formulated by the drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the central government in conjunction with the administrative departments of health at the same level.

Article 67 These Measures shall come into force from 1 July 2011 onwards. State Food and Drug Administration and the Ministry of Health on 4 March 2004 announced the "adverse drug reaction reporting and monitoring measures" (State Food and Drug Administration Decree No. 7) shall be repealed at the same time.