Drug recall management measures

State Food and Drug Administration Order

 

No. 29

 

The Measures for the Administration of Drug Recalls was reviewed and approved by the State Food and Drug Administration Bureau on December 6, 2007. It is hereby promulgated and will be implemented as of the date of promulgation.

 

 

Director Shao Mingli

December 10, 2007

Drug recall management method

 

Chapter 1 General

 

　　Article 1 In order to strengthen drug safety supervision and protect public drug safety, according to the Drug Administration Law of the People's Republic of China, the Regulations for the Implementation of the Drug Administration Law of the People's Republic of China, and the Special Provisions of the State Council on Strengthening the Safety Supervision and Administration of Food and Other Products, Formulate these measures.

　　Article 2 These Measures shall apply to the recall and supervision of drugs sold within the territory of the People's Republic of China.

　　Article 3 The term "drug recall" as mentioned in these Measures refers to the drug manufacturer (including the overseas pharmaceutical manufacturer of imported drugs, the same below) recovering the drugs that have been listed for sale and have potential safety hazards in accordance with the prescribed procedures.

　　Article 4 The term "safety hazard" as mentioned in these Measures refers to the unreasonable danger that the drug may endanger human health and life safety due to research and development, production and other reasons.

　　Article 5 Pharmaceutical production enterprises shall establish and improve the drug recall system in accordance with the provisions of these Measures, collect relevant information on drug safety, investigate and evaluate drugs that may have potential safety hazards, and recall drugs with potential safety hazards.

　　The pharmaceutical business enterprise and user unit shall assist the pharmaceutical production enterprise to fulfill the recall obligation, timely convey and feedback the drug recall information in accordance with the requirements of the recall plan, and control and recover the drugs with potential safety hazards.

　　Article 6 If a pharmaceutical trading enterprise or a user discovers that there is a potential safety hazard in the drugs it operates or uses, it shall immediately stop selling or using the drug, notify the pharmaceutical manufacturer or supplier, and report to the drug regulatory authority.

　　Article 7 Pharmaceutical production enterprises, operating enterprises and users shall establish and maintain complete purchase and sales records to ensure traceability of the drugs sold.

　　Article 8 The drug regulatory authorities of provinces, autonomous regions and municipalities directly under the Central Government where the pharmaceutical production enterprises are recalled shall be responsible for the supervision and administration of drug recalls, and the drug regulatory authorities of other provinces, autonomous regions and municipalities directly under the Central Government shall cooperate with and assist in the relevant work of drug recalls.

　　The State Food and Drug Administration supervises the management of drug recalls throughout the country.

　　Article 9 The State Food and Drug Administration and the drug regulatory authorities of provinces, autonomous regions and municipalities directly under the Central Government shall establish a drug recall information disclosure system and use effective means to publicize the information on drug safety and drug recalls with potential safety hazards.

 

　　Chapter II Investigation and Evaluation of Potential Drug Safety Hazards

 

　　Article 10 Pharmaceutical production enterprises shall establish and improve drug quality assurance systems and drug adverse reaction monitoring systems, collect and record drug quality problems and adverse drug reaction information, and report to drug regulatory authorities in a timely manner as required.

　　Article 11 A pharmaceutical production enterprise shall investigate the potential safety hazards of the drug.

　　When the drug regulatory authority investigates the potential safety hazards of the drug, the drug manufacturer shall provide assistance.

　　Pharmaceutical enterprises and users should cooperate with drug manufacturers or drug regulatory authorities to conduct investigations on drug safety hazards and provide relevant information.

　　Article 12 The contents of the investigation of hidden dangers of drug safety shall be determined according to actual conditions and may include:

　　(1) The type, scope and causes of adverse drug reactions that have occurred;

　　(2) Whether the use of the drug meets the requirements for the indications, usage and dosage specified in the drug label and label;

　　(3) Whether the quality of the drug meets the national standards, whether the pharmaceutical production process complies with the GMP regulations, and whether the process of drug production and approval is consistent;

　　(4) Whether the storage and transportation of drugs meet the requirements;

　　(5) The composition and proportion of the main users of the drug;

　　(6) The batch, quantity and circulation area and scope of the drug that may have potential safety hazards;

　　(7) Other factors that may affect the safety of drugs.

　　Article 13 The main contents of the drug safety hazard assessment include:

　　(1) The possibility of causing harm to the drug and whether it has caused harm to human health;

　　(2) The harmful effects on the main users;

　　(3) The harmful effects on special populations, especially high-risk groups, such as the elderly, children, pregnant women, liver and kidney dysfunction, and surgical patients;

　　(4) The severity and urgency of the hazard;

　　(5) The consequences of the hazard.

　　Article 14 According to the seriousness of drug safety hazards, drug recalls are divided into:

　　(1) Level 1 recall: the use of the drug may cause serious health hazards;

　　(2) Secondary recall: the use of the drug may cause temporary or reversible health hazards;

　　(3) Three-level recall: The use of the drug generally does not cause health hazards, but it needs to be recovered for other reasons.

　　The pharmaceutical production enterprise shall scientifically design the drug recall plan and organize its implementation according to the recall classification and drug sales and use.

 

　　Chapter III Voluntary Recall

 

　　Article 15 A pharmaceutical production enterprise shall analyze the collected information, and conduct investigation and evaluation on the drugs that may have potential safety hazards in accordance with the requirements of Articles 12 and 13 of these Measures. If it is found that the drug has potential safety hazards, it shall decide to recall. .

　　Where an overseas pharmaceutical manufacturer of imported drugs conducts a drug recall overseas, it shall promptly report to the State Food and Drug Administration; if the recall is conducted within the territory, the importing unit shall be responsible for the specific implementation in accordance with the provisions of these Measures.

　　Article 16 After making a drug recall decision, a pharmaceutical production enterprise shall formulate a recall plan and organize its implementation. The first-level recall shall be within 24 hours, the second-level recall within 48 hours, and the third-level recall within 72 hours, and the relevant drugs shall be notified. The operating enterprises and users shall stop selling and using them, and report to the drug regulatory authorities of the local provinces, autonomous regions and municipalities directly under the Central Government.

　　Article 17 After the drug production enterprise starts the drug recall, the first-level recall is within 1 day, the second-level recall is within 3 days, and the third-level recall is within 7 days. The investigation and evaluation report and the recall plan shall be submitted to the local province, autonomous region or municipality directly under the Central Government. The drug regulatory authority shall file the record. The drug regulatory authorities of provinces, autonomous regions, and municipalities directly under the Central Government shall report to the State Food and Drug Administration for the investigation and evaluation report and recall plan for receipt of the first-level drug recall.

Article 18 The investigation and evaluation report shall include the following contents:

(1) The specific information of the recalled drugs, including basic information such as name and batch;

(2) Reasons for the implementation of the recall;

(3) survey and evaluation results;

(4) Recall classification.

The recall plan should include the following:

(1) The production and sales of pharmaceuticals and the number of recalls;

(2) The specific content of the recall measures, including the organization, scope and time limit of implementation;

(3) Ways and scope of publication of recall information;

(4) the expected effect of the recall;

(5) Treatment measures after drug recall;

　　(6) The name and contact information of the contact person.

　　Article 19 The drug regulatory authorities of provinces, autonomous regions and municipalities directly under the Central Government may organize experts to evaluate the recall plans submitted by pharmaceutical manufacturers according to actual conditions, and believe that the measures taken by pharmaceutical manufacturers cannot effectively eliminate potential safety hazards and may require pharmaceutical manufacturers. Take more effective measures such as expanding the scope of recall and shortening the recall time.

　　Article 20 If a pharmaceutical production enterprise makes a change to the reported recall plan, it shall promptly report it to the drug regulatory authority for record.

　　Article 21 In the process of implementing the recall, the pharmaceutical production enterprises shall recall the first-level recall, the second-level recall every 3 days, and the third-level recall every 7 days, and report the progress of drug recall to the drug regulatory authorities of the local provinces, autonomous regions and municipalities directly under the Central Government. Happening.

　　Article 22 A pharmaceutical production enterprise shall have a detailed record of the handling of recalled drugs and report to the drug regulatory authority of the province, autonomous region or municipality directly under the Central Government where the pharmaceutical production enterprise is located. Drugs that must be destroyed shall be destroyed under the supervision of the drug regulatory authority.

　　Article 23 After the recall is completed, the pharmaceutical production enterprise shall evaluate the recall effect and submit a drug recall summary report to the drug regulatory authority of the province, autonomous region or municipality directly under the Central Government.

　　Article 24 The drug supervision and administration department of a province, autonomous region or municipality directly under the Central Government shall examine the report within 10 days from the date of receipt of the summary report, evaluate the recall effect, and organize experts for review and evaluation if necessary. The review and evaluation conclusions should be notified to the pharmaceutical manufacturer in writing.

　　After review and evaluation, if the recall is not thorough or more effective measures are needed, the drug regulatory authority shall require the pharmaceutical production enterprise to recall or expand the scope of the recall.

 

Chapter IV Ordering the recall

 

　　Article 25 After investigation and evaluation, the drug regulatory authority considers that there is a potential safety hazard as mentioned in Article 4 of these Measures. If a pharmaceutical production enterprise should recall the drug without actively recalling it, it shall order the drug manufacturer to recall the drug.

　　When necessary, the drug regulatory authority may require pharmaceutical manufacturers, operating companies and users to immediately stop selling and using the drug.

　　Article 26 If the drug supervision and administration department makes a decision to order a recall, it shall send a notice of the recall of the order to the pharmaceutical production enterprise. The notice includes the following contents:

　　(1) The specific information of the recalled drugs, including basic information such as name and batch;

　　(2) Reasons for the implementation of the recall;

　　(3) survey and evaluation results;

　　(4) Recall requirements, including scope and time limit.

　　Article 27 After receiving the notice of recall, the pharmaceutical production enterprise shall notify the pharmaceutical business enterprise and the user unit in accordance with the provisions of Articles 16 and 17 of these Measures, formulate and submit a recall plan, and organize the implementation.

　　Article 28 A pharmaceutical production enterprise shall report the relevant situation of the drug recall to the drug regulatory authority in accordance with the provisions of Articles 20, 21, 22 and 23 of these Measures, and conduct a recall. Subsequent processing of drugs.

The drug supervision and administration department shall review the drug recall summary report submitted by the drug manufacturer in accordance with the provisions of Article 24 of these Measures, and evaluate the recall effect. After review and evaluation, if the recall is not thorough or more effective measures are needed, the drug regulatory authority may require the drug manufacturer to recall or expand the scope of the recall.

 

　　Chapter V Legal Liability

 

　　Article 29 The drug regulatory authority shall confirm that a drug manufacturer violates laws, regulations and rules, causing potential safety hazards of listed drugs, and shall impose administrative penalties according to law. However, if the enterprise has taken recall measures to actively eliminate or mitigate the harmful consequences, The provisions of the Administrative Punishment Law shall be lighter or mitigated; if the illegal acts are minor and promptly corrected, and no harmful consequences are caused, no penalty shall be imposed.

　　If a pharmaceutical manufacturer recalls a drug, it will not be exempted from other legal liabilities that it should bear according to law.

　　Article 30 If a pharmaceutical production enterprise violates the provisions of these Measures and discovers that there is a safety hazard in the drug and does not take the initiative to recall the drug, it shall order the drug to be recalled and shall be charged a fine of 3 times the value of the drug; if the serious consequences are caused, the original certificate shall be issued. The department revokes the drug approval certificate until the drug production license is revoked.

　　Article 31 If a pharmaceutical production enterprise violates the provisions of Article 25 of these Measures and refuses to recall the drug, it shall recall a fine of 3 times the value of the drug; if serious consequences are caused, the original issuing department shall cancel the drug approval certificate. Until the drug production license is revoked.

　　Article 32 If a pharmaceutical production enterprise violates the provisions of Article 16 of these Measures and fails to notify the pharmaceutical business enterprise or the user to stop selling and using the drug to be recalled within the prescribed time, it shall be warned, ordered to correct within a time limit, and shall be charged 30,000 yuan. The following fine.

　　Article 33 If a pharmaceutical production enterprise violates the provisions of Article 19, Article 24, paragraph 2, and Article 28, paragraph 2 of these Measures, and fails to take corrective measures or recall drugs according to the requirements of the drug regulatory authority, Warned, ordered to correct within a time limit, and imposed a fine of less than 30,000 yuan.

　　Article 34 If a pharmaceutical production enterprise violates the provisions of Article 22 of these Measures, it shall be given a warning, ordered to make corrections within a time limit, and imposed a fine of not more than 30,000 yuan.

　　Article 35 If a pharmaceutical production enterprise has one of the following circumstances, it shall be warned and ordered to make corrections within a time limit; if it fails to make corrections within the time limit, it shall be fined not more than 20,000 yuan:

　　(1) failing to establish a drug recall system, a drug quality assurance system and a drug adverse reaction monitoring system in accordance with the provisions of these Measures;

　　(2) Refusing to assist the drug regulatory authority to conduct investigations;

　　(3) The investigation and evaluation report and the recall plan, the progress of the drug recall and the summary report of the drug recall that have not been submitted in accordance with the provisions of these Measures;

　　(4) The recall plan was changed and not reported to the drug regulatory authority for filing.

　　Article 36 If a pharmaceutical business enterprise or user unit violates the provisions of Article 6 of these Measures, it shall be ordered to stop selling and using it, and shall be imposed a fine of not less than 1,000 yuan but not more than 50,000 yuan; if serious consequences are caused, the original issuing department shall revoke the drug Business License or other license.

　　Article 37: A pharmaceutical business enterprise or a user that refuses to cooperate with a pharmaceutical production enterprise or a drug regulatory authority to carry out investigations on hidden dangers of drug safety and refuses to assist drug manufacturers to recall drugs shall be warned and ordered to correct, and may be placed under 20,000 yuan. fine.

　　Article 38 If the drug supervision and administration department and its staff fail to perform their duties or abuse their powers, they shall be dealt with in accordance with the relevant laws and regulations.

 

Chapter VI Supplementary Provisions

 

Article 39 The State Food and Drug Administration is responsible for the interpretation of these Measures.

Article 40 These Measures shall come into force as of the date of promulgation.