Order of the State Food and Drug Administration
(No.7)
The Measures for the Administration on Report and Monitoring of the Side Effect of Pharmaceuticals, which have been deliberated and adopted by the Ministry of Health of the People’s Republic of China and the State Food and Drug Administration, are hereby promulgated by the sequence number of the order of the State Food and Drug Administration, and shall come into force as of the date of promulgation.
Minister of the Ministry of Public Health of the People’s Republic of China: Wuyi
Director General of the State Food and Drug Administration: Zheng Xiaoyu
March 4, 2004
Measures for the Administration on Report and Monitoring of the Side Effect of Pharmaceuticals
Chapter I General Provisions
Article 1 The present Measures are hereby formulated in accordance with the Pharmaceutical Administration Law of the People’s Republic of China for the purpose of strengthening supervision over the safety of the listed pharmaceuticals, regulating the administration on report and monitoring of the side effect of pharmaceuticals, and safeguarding the safety of drug use by the general public.
Article 2 The state implements the pharmaceutical side effect reporting system. The pharmaceutical production enterprises, operation enterprises and medical and public health institutions shall report the side effect of pharmaceuticals they find as required.
Article 3 The State Food and Drug Administration shall take charge of the work for monitoring the side effect of pharmaceuticals nationwide. The food and drug administrations of the people’s governments of the provinces, autonomous regions, and municipalities directly under the Central Government shall take charge of the work for monitoring the side effect of pharmaceuticals within their own administrative districts. And the competent public health departments at all levels shall be responsible for the administration of the work of the medical and public health institutions with respect to their implementation of the pharmaceutical side effect reporting system.
Article 4 The present Measures shall be applicable to the pharmaceutical production or operation enterprises and medical and public health institutions, the special institutions for monitoring the side effect of pharmaceuticals, the departments of food and drug administration, and other relevant competent departments in-charge within the territory of the People’s Republic of China.
Article 5 The state encourages the relevant entities and individuals to report the side effect of pharmaceuticals.
Chapter II Duties
Article 6 The State Food and Drug Administration shall be responsible for the administration of monitoring the side effect of pharmaceuticals nationwide, and perform the following main duties:
1. Formulating regulations and policies concerning the administration on report of side effect of pharmaceuticals together with the Ministry of Public Health, and supervising over their implementation;
2. Circulating notice on conditions of report and monitoring of side effect of pharmaceuticals nationwide;
3. Organizing to inspect the pharmaceutical production and operation enterprises on their carrying out of the work for reporting and monitoring the side effect of pharmaceuticals, and organizing to inspect the medical and public health institutions on their carrying out of the work for reporting and monitoring the side effect of pharmaceuticals together with the Ministry of Public Health;
4. Organizing to investigate, confirm and handle the side effect of pharmaceuticals, which are of sudden or colonial outburst, and have greater influence and cause serious consequences; and
5. The State Food and Drug Administration may, for pharmaceuticals that have been confirmed of occurrence of serious side effect, take emergency control measures and make administrative decision according to law.
Article 7 The food and drug administrations of the provinces, autonomous regions, and municipalities directly under the Central Government shall be responsible for the administration on monitoring the side effect of pharmaceuticals within their own administrative districts, and perform the following main duties:
1. Formulating the report on pharmaceutical side effect and provisions on the administration thereof within their own administrative districts, and supervising over their implementation;
2. Organizing the work of publicity, education and training of the report and monitoring of the side effect of pharmaceuticals within their own administrative districts together with the competent health department at the same level;
3. Organizing to inspect the pharmaceutical production and operation enterprises on their carrying out of the work for reporting and monitoring the side effect of pharmaceuticals within their own administrative districts, and organizing to inspect the medical and public health institutions on their carrying out of the work for reporting and monitoring the side effect of pharmaceuticals within their own administrative districts together with the competent health department of the same level;
4. Organizing to investigate, confirm and handle the serious side effect of pharmaceuticals occurred within their own administrative districts; and
5. The food and drug administrations of provinces, autonomous regions, and municipalities directly under the Central Government may, for pharmaceuticals that have been confirmed of occurrence of serious side effect within their own administrative districts, take emergency control measures and make decisions on handling them administratively according to law.
Article 8 The competent health department of the State Council and the competent local health departments at all levels shall, within the scope of their own functions, take relevant emergency measures according to law against the side effect of pharmaceuticals confirmed.
Article 9 The state center for monitoring the side effect of pharmaceuticals undertakes the work of monitoring technology for side effect of pharmaceuticals nationwide, and performs the following main duties under the leadership of the State Food and Drug Administration:
1. Undertaking the work for collection, appraisal, feedback and report of the data concerning the report on pharmaceuticals side effect nationwide;
2. Giving technical guidance to the centers for monitoring the side effect of pharmaceuticals of the provinces, autonomous regions, and municipalities directly under the Central Government;
3. Undertaking the work for the construction and maintenance of the information database and monitoring network for the side effect of pharmaceuticals of the state;
4. Organizing the work for the publicity, education, and training of the side effect of pharmaceuticals and the compilation and publication of the information publications for side effect of pharmaceuticals;
5. Participating in the international communications on pharmaceutical side effect monitoring
; and
6. Organizing the research on the methods for monitoring the side effect of pharmaceuticals.
Article 10 The centers for monitoring the side effect of pharmaceuticals of the provinces, autonomous regions, and municipalities directly under the Central Government shall, under the leadership of the food and drug administrations of the provinces, autonomous regions, and municipalities directly under the Central Government, undertake the collection, verification, appraisal, feedback, and report of the data for the report on pharmaceuticals side effect within their own administrative districts and other relevant work.
Article 11 The personnel of the centers for monitoring the side effect of pharmaceuticals shall have the relevant special knowledge such as the medicine and pharmaceutical, etc., and the ability to accurately analyze the data for report on pharmaceutical side effect.
Chapter III Reporting
Article 12 The system of reporting level by level and by periods shall be implemented on the side effect of pharmaceuticals, and a report exceeding the immediate leadership may be permitted if necessary.
Article 13 The pharmaceutical production or operation enterprises and medical and public health institutions shall assign full time or part-time personnel to be responsible for the work of reporting and monitoring the side effect of pharmaceuticals, which are produced, managed, and used by their own entities, and shall specify, investigate into, analyze, appraise, and handle the side effect that may be related to the use of pharmaceuticals they find. And they shall fill in the Report Form for Events of Side Effects of Pharmaceuticals, and report uniformly to the centers for monitoring the side effect of pharmaceuticals of the provinces, autonomous regions, and municipalities directly under the Central Government at their localities by quarter, of which, the report of new or serious side effect of pharmaceuticals shall be made within 15 days from the date they have been found out, and the death case shall be reported in time.
Article 14 The contents filled in the Report Form for Events of Pharmaceutical Side Effect shall be true, complete, and accurate.
Article 15 All the side effects of a new pharmaceutical, which is within the monitoring period, shall be reported. And the new and serious side effect of a new pharmaceutical, whose monitoring period has expired, shall be reported.
A pharmaceutical production enterprise shall, in addition to making reports in accordance with the provisions of Article 13, also report to the centers for monitoring the side effect of pharmaceuticals of the provinces, autonomous regions, and municipalities directly under the Central Government at their localities after making annual collection in the form of Periodical Summary Statement for Events of Pharmaceutical Side Effect. For the new pharmaceuticals that are within the monitoring period, a summary reporting shall be made once a year. For the new pharmaceuticals whose monitoring period has expired, a summary report shall be made once in the year when the period of validity of the certification documents of approval for the first batch of pharmaceuticals has expired. And afterwards, a summary report shall be made for them once every five years.
Article 16 All the side effects of an imported pharmaceutical shall be reported within five years from the date when the approval for its import is granted for the first time. Its new and serious side effect shall be reported when the time for its import has reached five full years. In addition, an annual summary report shall also be made on the side effect of an imported pharmaceutical. A summary report shall be made on the imported pharmaceutical once a year within five years from the date when the approval for its import is granted for the first time. If the time for its import has reached five full years, a summary report shall be made once every five years.
Where the new or serious side effect of the imported pharmaceutical has occurred in other countries or districts, the entities managing the imported pharmaceuticals as agents shall report this to the state center for monitoring the side effect of pharmaceuticals within one month from the date of finding such side effect.
Article 17 Where the pharmaceutical production or operation enterprises or medical and public health institutions find colonial side effect, they shall immediately report it to the food and drug administrations, public health offices or bureaus and the centers for monitoring the side effect of pharmaceuticals of the provinces, autonomous regions, and municipalities directly under the Central Government at their localities. And the food and drug administrations of the provinces, autonomous regions, and municipalities directly under the Central Government shall organize to make investigation and verification immediately together with the public health offices or bureaus of the same level, and report to the State Food and Drug Administration, Ministry of Public Health, and the state center for monitoring the side effect of pharmaceuticals.
Article 18 Where any individual finds the new or serious side effect caused by pharmaceuticals, he/she may directly report to the centers for monitoring the side effect of pharmaceuticals or the food and drug administrations of the provinces, autonomous regions, and municipalities directly under the Central Government where he/she lives.
Article 19 The centers for monitoring the side effect of pharmaceuticals at the provinces, autonomous regions, and municipalities directly under the Central Government shall report the general side effect reports they have collected to the state center for monitoring the side effect of pharmaceuticals on a quarterly basis, and verify the report on the new or serious side effect, and make report within 3 days from the date of receiving such report, meanwhile, send a copy to the food and drug administrations and the public health offices or bureaus of the corresponding provinces, autonomous regions, and municipalities directly under the Central Government. They shall report the periodical summary reports they have collected to the state center for monitoring the side effect of pharmaceuticals each year.
Article 20 The state center for monitoring the side effect of pharmaceuticals shall report the statistical data of pharmaceutical side effect monitoring to the State Food and Drug Administration and the Ministry of Public Health half a year, of which the data concerning the report on new and serious side effect and colonial side effect shall be reported in time after analysis and appraisal.
Article 21 The centers for monitoring the side effect of pharmaceuticals shall reflect the relevant information to the entities or individuals who report the side effect of pharmaceuticals.
Chapter IV Appraisal and Control
Article 22 The pharmaceutical production or operation enterprises and medical and public health institutions shall often make analyses and appraisals on the side effect of the pharmaceuticals produced, managed and used by their own entities, and take effective measures to reduce and prevent the repeat occurrence of side effect of pharmaceuticals.
Article 23 The centers for monitoring the side effect of pharmaceuticals of the provinces, autonomous regions, and municipalities directly under the Central Government shall verify in time the report on side effect of pharmaceuticals, and make objective, scientific and overall analyses thereon, putting forward appraisal opinions of relevancy, and report the analyses and appraisal opinions to the state center for monitoring the side effect of pharmaceuticals, who shall then make further analysis and appraisal.
Article 24 The State Food and Drug Administration may, on the basis of the analysis and appraisal conclusions, take such measures as ordering to revise the pharmaceutical instructions, suspending the production, sales and use thereof. If the pharmaceuticals have serious side effect or are dangerous to physical health of people due to other reasons, the certification documents of approval of the pharmaceuticals shall be revoked and the issue shall be publicized.
The pharmaceuticals whose certification documents of approval have been revoked shall not be produced or imported, sold and used. In case the pharmaceuticals have been produced or imported, they shall be destroyed or disposed under the supervision of the local departments of food and drug administration.
Article 25 Where the pharmaceuticals have been confirmed of occurrence of serious side effect, they shall be handled in accordance with the relevant provisions of Article 71 of the Pharmaceutical Administration Law.
Article 26 The State Food and Drug Administration shall circulate a notice on the report and monitoring of pharmaceuticals side effect of the state periodically.
Chapter V Punishments
Article 27 In case the pharmaceutical production or operation enterprises and drug use entities other than the medical institutions have any of the following circumstances, the departments of food and drug administration at or above the provincial level shall, in light of the seriousness of circumstances, order them to correct, circulate a notice of criticism or give warnings, and concurrently impose a fine of RMB 1 thousand Yuan up to RMB 30 thousand Yuan. They shall impose punishments in light of the prescriptions of the relevant laws and regulations, if the circumstance is serious enough and causes serious consequences.
1. Having no full time or part-time personnel to be responsible for the work of monitoring the side effect of pharmaceuticals of the respective entity;
2. Failing to report the side effect of pharmaceuticals as required;
3. Concealing and not reporting the side effect of pharmaceuticals they find;
4. Failing to revise the pharmaceutical instructions as required; or
5. Disguising the data of pharmaceuticals side effect.
Where a medical and public health institution has any one of the preceding acts, the departments of food and drug administration shall transfer it to the competent department of public health at the same level for handling.
Article 28 In case the departments of food and drug administration and their relevant staff members violate the regulations, delay the report on side effect, or fail to take effective measures to control the repeated occurrence of serious side effect of pharmaceuticals in the administration of monitoring side effect of pharmaceuticals, which result in serious consequences, they shall be imposed upon an administrative punishment in accordance with the relevant provisions.
Chapter VI Supplementary Provisions
Article 29 The following terms in the present Measures shall have the following meanings:
1. Side Effect of Pharmaceuticals shall refer to the deleterious effect of compliance pharmaceuticals, which arise under the ordinary usage or dosage in no relation to the purpose of pharmaceutical use or accidental deleterious effect.
2. Report and Monitoring of Side Effect of Pharmaceuticals shall refer to the process of finding out, reporting, appraising and controlling the side effect of pharmaceuticals.
3. New Side Effect of Pharmaceuticals shall refer to the side effect not specified in the pharmaceutical instructions. And
4. Serious Side Effect of Pharmaceuticals shall refer to one of the following damages arising from taking the medicine:
1. Leading to death;
2. Leading to cancer, freak, or born defect;
3. Endangering life and being capable of resulting in permanent or obvious disability of human body;
4. Producing permanent injury to the function of organs; or
5. Resulting in living in hospital or extension of time in hospital.
Article 30 The contents and statistical data of the report on side effect of pharmaceuticals are the basis for strengthening drug supervision and administration and guiding the use of pharmaceuticals properly, which shall not be taken as the basis for medical malpractice, medical treatment litigation and handling of accidents concerning pharmaceutical quality.
Article 31 The detailed rules for the implementation of the measures of the People’s Liberation Army of the Chinese People for the administration on report and monitoring of side effect of pharmaceuticals shall be formulated according to the present Measures.
Article 32 The present Measures shall be interpreted by the State Food and Drug Administration together with the Ministry of Public Health.
Article 33 The present Measures shall be implemented as of the date of promulgation. The Measures for the Administration of Monitoring Side Effect of Pharmaceuticals (for Trial Implementation) as promulgated jointly by the former State Drug Supervision and Administration Bureau and the Ministry of Public Health on November 26, 1999 shall be repealed simultaneously.
Attachment:
1. Report Form for Events of Pharmaceutical Side Effect (Omitted)
2. Report Form for Events of Colonial Pharmaceutical Side Effect (Omitted)
3. Periodical Summary Report on Events of Pharmaceutical Side Effect (Omitted)
