Administrative Measures On Drug Recall

Original Language Title: 药品召回管理办法

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(December 10, 2007 the State food and drug administration released 29th come into force on the date of promulgation) Chapter I General provisions article to strengthen drug safety, protection of public safety, under the People's Republic of China pharmaceutical administration law and the People's Republic of China pharmaceutical administration law implementing regulations, the State Council on strengthening food and other product safety supervision and management of special provisions, these measures are formulated.
    Article in the People's Republic of China recalls of medicines sold in supervision and management, application of this approach.
    Third drug recalls in these measures refers to pharmaceutical production enterprises (including foreign pharmaceutical manufacturers of imported drugs, the same below) in accordance with the procedures set out to recover drug already on the market are unsafe.
    Article fourth safety in these measures refers to as research and development, production and other reasons might make drugs endangers human health and safety of unreasonable risk.
    Fifth pharmaceutical producing enterprises shall, in accordance with the regulations establish and improve drug recall system, collecting information on drug safety, drug investigations, assessment can have security implications, and recall unsafe drugs.
    Drug distributors, using units shall assist the drug manufacturers perform their recall obligations, in accordance with the recall program requires timely communication, feedback and drug recall information, control and retrieval of potentially unsafe drugs.
    Sixth pharmaceutical trading enterprises, users found their business, the use of drugs are unsafe, should immediately stop selling or using the drug, notify the manufacturer or supplier, and report to the pharmaceutical supervisory and administrative departments.
    Seventh pharmaceutical producing enterprises, trading enterprises and units shall establish and maintain complete records of purchase and sale, guarantee the traceability of sales of drugs.
    Article eighth recall of drug manufacturers where provinces, autonomous regions and municipalities directly under the pharmaceutical supervisory and Administrative Department is responsible for the supervision and administration of drug recalls, drug regulatory agency of provinces, autonomous regions and municipalities shall cooperate with the related work of the, assist in drug recall.
    State food and Drug Administration national drug recall management.
    Nineth and the State food and drug administration of provinces, autonomous regions and municipalities directly under the pharmaceutical supervisory and administrative departments shall establish a drug recall information public system, an effective way to publicize potentially unsafe drug information and drug recalls.
    Chapter II administration of pharmaceutical safety hazard investigation and assessment tenth pharmaceutical producing enterprises shall establish and improve drug quality assurance system and adverse drug reactions monitoring system collects, records and drug quality problems and adverse drug reaction information, and provides timely reports to the pharmaceutical supervisory and administrative departments.
    11th pharmaceutical producing enterprises shall investigate drug safety hazard that may exist.
    Pharmaceutical supervisory and administrative departments when there may be a safety hazard investigation of drugs, pharmaceutical producing enterprises shall provide assistance.
    Drug distributor, use shall cooperate with the drug manufacturers or pharmaceutical supervisory and Administrative Department of the relevant drug safety survey, providing relevant information.
    12th article drug security hidden survey of content should according to reality determine, can including: (a) has occurred drug bad event of type, and range and the reasons; (ii) drug using whether meet drug manual, and label provides of indications, and usage dosage of requirements; (three) drug quality whether meet national standards, drug production process whether meet GMP, provides, drug production and approved of process whether consistent; (four) drug store, and transport whether meet requirements;
    (E) primarily use composition and proportion of population (vi) there may be a hidden batch of drugs, the quantity and the circulation areas and ranges; (VII) other factors that may affect drug safety.
    13th article drug security hidden assessment of main content including: (a) the drug raised against of possibilities, and whether has on human health caused has against; (ii) on main using crowd of against effect; (three) on special crowd, especially high-risk crowd of against effect, as old, and children, and pregnant women, and liver kidney function not full who, and surgical patients,; (four) against of serious and emergency degree; (five) against led to of consequences.
    Article 14th, based on the severity of drug safety, drug recalls are divided into: (a) level of recall: use of the drug can cause serious health hazards, (ii) secondary recall: use of the drugs may cause temporary or reversible health effects, (iii) three levels of recall: use of the drug does not cause health hazards, but there are other reasons need to recover.
    Pharmaceutical producing enterprises shall, in accordance with the recall classification and drug sales and use of design plan and organize the implementation of drug recall.
    Chapter three is voluntarily recalling 15th pharmaceutical producing enterprises shall analyze the information collected, may potentially unsafe drugs in accordance with the present article 12th, 13th calls for investigation and evaluation, found that drugs are unsafe, it should be decided to recall.
    Foreign pharmaceutical manufacturers of imported drugs outside of drug recalls, shall promptly report to the State food and Drug Administration; recalled in the territory, by the importer in accordance with the provisions for implementation of the measures.
    16th pharmaceutical producing enterprises in making drug recall decision, should develop a recall plan and organize the implementation level recall within 24 hours, secondary recalled within 48 hours, three levels of recall within 72 hours, notification to the relevant enterprises, and use end the sale and use of drugs, as well as to local drug regulatory agency of provinces, autonomous regions and municipalities directly under the report. 17th pharmaceutical producing enterprises after the start of drug recall, recalled 1st level in the 3rd secondary recall, recalled 7th grade in the investigation report and recall plan should be submitted to the home province, autonomous region, or municipality directly under the supervision and Management Department.
    The provinces, autonomous regions and municipalities directly under the pharmaceutical supervisory and administrative departments shall receive a level of drug recall investigation and assessment of reports and recall report to the State food and drug administration.
    Article 18th assessment report should include the following: (a) the recall of specific drugs, including basic information such as name, batch, (ii) reasons for recall; (c) the survey results (iv) recall ratings.
    Recalled plans should including following content: (a) drug production sales situation and the intends recalled of number; (ii) recalled measures of specific content, including implementation of organization, and range and time,; (three) recalled information of announced way and range; (four) recalled of expected effect; (five) drug recalled Hou of processing measures; (six) contact people of name and the contact way.
    19th of provinces, autonomous regions and municipalities directly under the pharmaceutical supervisory and administrative department according to organize experts to assess drug manufacturers to submit recall plans, that measures taken by the drug manufacturer is not effective in eliminating the security vulnerability, can ask the manufacturer an expanded recall, shorten the time of recall and other more effective measures.
    20th recall of pharmaceutical producing enterprises reported plans to make changes, shall report the pharmaceutical supervisory and administrative department.
    21st pharmaceutical producing enterprises in the process of recall, recall daily level, secondary recall each 3rd grade recall every 7th to the local provinces, autonomous regions and municipalities directly under the supervision and management departments report progress in drug recall. 22nd drug manufacturers to recall of drug treatment should be to maintain detailed records, and the drug manufacturer is located province, autonomous region, or municipality directly under the supervision and Management Department reports.
    Must destroy the drug shall be destroyed under the supervision of drug regulatory authorities.
    Article 23rd manufacturer recall is completed, should evaluate the effect on recall, to the local provinces, autonomous regions, municipalities directly under the pharmaceutical supervisory and administrative department drug recall reports. Article 24th of provinces, autonomous regions and municipalities directly under the pharmaceutical supervisory and administrative departments shall, from the date of receipt of the summary report to review the report in the 10th, and recall effect is evaluated and, if necessary, expert review and evaluation.
    Review and evaluation shall notify the manufacturer in writing.
    After review and assessment, think recall is not complete or the need to take more effective measures, the pharmaceutical supervisory and administrative departments shall require drug manufacturers to bring back or expanding the scope of recalls.
    The fourth chapter shall be ordered to recall article 25th after an investigation to assess the drug regulatory agency, that there are mentioned in this article fourth security risks, drug manufacturers should recall without a voluntary recall of pharmaceuticals, shall order the manufacturer to recall the drug.
    If necessary, the pharmaceutical supervisory and administrative department may require pharmaceutical producing enterprises, trading enterprises and units to immediately cease the sale and use of the drug.
    Article 26th pharmaceutical supervisory and administrative departments shall be ordered to recall decision, ordered a recall notice should be served on the manufacturer, the notice includes the following: (a) the recall of specific drugs, including basic information such as name, batch, (ii) reasons for recall; (c) the survey results (iv) recall requires, including scope and duration, and so on.
    27th manufacturer after receipt of the order the recall notice, shall, in accordance with article 16th, 17th to inform drug distributors and users, develop, submit recall plans, and their implementation. 28th pharmaceutical producing enterprises shall, in accordance with the article 20th, 21st, 22nd, 23rd the pharmaceutical supervisory and administrative department in accordance with reports of drug recall, recalled drugs to deal with later.

    Pharmaceutical supervisory and administrative departments shall, in accordance with the provisions of article 24th of this approach submitted by the drug manufacturer recalls summary report review and recall effect is evaluated.
    After review and assessment, think recall is not complete or the need to take more effective measures, the pharmaceutical supervisory and administrative department may require the manufacturer recall or expand the scope of recalls.
    Fifth chapter legal responsibility 29th article drug supervision management sector confirmed drug production enterprise for violation legal, and regulations, and regulations provides caused listed drug exists security hidden, law should give administrative punishment, but the enterprise has take recalled measures active elimination or reduce against consequences of, in accordance with administrative punishment method of provides lighter or reduce punishment; violations minor and timely corrected, no caused against consequences of, not punishment.
    Drug manufacturers of recalled medicines, does not exempt shall bear the legal responsibility.
    30th drug-producing enterprises in violation of the rules, found that drugs are unsafe and not voluntarily recalled the drug, shall be ordered to recall drugs, and 3 times the amount of the fine in the value should recall drugs causing serious consequences, the original certificate revoked by the Department and drug approval documents, until revocation of the pharmaceutical production license.
    31st manufacturer violated these measures article 25th, refused to recall the drug, 3 times the amount of the fine in the value should recall drugs causing serious consequences, the original certificate revoked by the Department and drug approval documents, until revocation of the pharmaceutical production license.
    32nd pharmaceutical producing enterprises in violation of these regulations article 16th, is not within the specified time pharmaceutical trading enterprises, and use stop sales and use of recalled medicines, with a warning, rectification, and fines of between 30,000 yuan.
    33rd pharmaceutical producing enterprises in violation of the article 19th, 24th, 28th in the second paragraph of article, not according to the pharmaceutical supervisory and administrative departments to take corrective measures or recall of drugs, with a warning, rectification, and fines of between 30,000 yuan.
    34th pharmaceutical producing enterprises that violate the provisions of this article 22nd, with a warning, rectification, and fines of between 30,000 yuan. 35th article drug production enterprise has following case one of of, be warning, ordered deadline corrected; late not corrected of, at 20,000 yuan following fine: (a) not by this approach provides established drug recalled system, and drug quality guarantee system and drug bad reaction monitoring system of; (ii) refused to assist drug supervision management sector carried out survey of; (three) not according to this approach provides submitted drug recalled of survey assessment report and recalled plans, and drug recalled progress situation and summary report of; (four) change recalled plans,
    Not reported pharmaceutical supervisory and administrative departments for the record.
    Article 36th drug distributor, use in violation of the provisions of article sixth, to order the suspension of sales and use, and more than 1000 Yuan and fined a maximum of 50,000 yuan, causing serious consequences, revoked by the original licensing sector of the pharmaceutical trade license or any other license.
    37th pharmaceutical trading enterprises, the use of units refused to cooperate with drug manufacturers or pharmaceutical supervisory and Administrative Department of the relevant drug safety hazard investigation, refusing to assist drug manufacturers recalled drugs, with a warning and order them to correct, may be fined a maximum of 20,000 yuan.
    Article 38th pharmaceutical supervisory and administrative departments and their staff failed to perform their duties or abuse of powers, be dealt with in accordance with the provisions of relevant laws and regulations.
    Sixth chapter supplementary articles article 39th explain these measures by the State food and drug administration.
                                                                                                            40th these measures come into force on the date of promulgation.

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