Drug Recall Management Measures

Order of the State Food and Drug Administration

 

No. 29

 

The "Measures for the Administration of Drug Recalls" was reviewed and approved by the State Food and Drug Administration's bureau meeting on December 6, 2007, and is hereby promulgated and shall come into effect from the date of promulgation.

 

 

Director Shao Mingli

December 10, 2007

 

 

 

 

Measures for the Administration of Drug Recalls

 

Chapter 1 General Provisions

 

　　Article 1 To strengthen drug safety supervision and ensure public medication safety, these measures are formulated in accordance with the "Drug Administration Law of the People's Republic of China", the "Implementation Regulations of the Drug Administration Law of the People's Republic of China", and the "Special Provisions of the State Council on Strengthening the Supervision and Administration of Food and Other Products' Safety".

　　Article 2 These measures 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 used in these measures refers to the process by which drug manufacturing enterprises (including overseas pharmaceutical manufacturers of imported drugs, hereinafter the same) retrieve drugs with safety hazards that have been marketed according to prescribed procedures.

　　Article 4 The term "safety hazard" as used in these measures refers to unreasonable risks that may endanger human health and life safety due to reasons such as research and development or production.

　　Article 5 Drug manufacturing enterprises shall establish and improve the drug recall system in accordance with these measures, collect relevant information on drug safety, investigate and evaluate drugs that may have safety hazards, and recall drugs with safety hazards.

　　Drug distribution enterprises and users shall assist drug manufacturing enterprises in fulfilling recall obligations, promptly convey and feedback drug recall information according to the recall plan requirements, and control and retrieve drugs with safety hazards.

　　Article 6 If drug distribution enterprises or users discover that the drugs they distribute or use have safety hazards, they shall immediately stop selling or using such drugs, notify the drug manufacturing enterprises or suppliers, and report to the drug supervision and administration department.

　　Article 7 Drug manufacturing enterprises, distribution enterprises, and users shall establish and keep complete purchase and sales records to ensure the traceability of sold drugs.

　　Article 8 The drug supervision and administration departments of the provinces, autonomous regions, and municipalities where the drug manufacturing enterprises are located are responsible for the supervision and administration of drug recalls. Other provinces, autonomous regions, and municipalities' drug supervision and administration departments shall cooperate and assist in the relevant work of drug recalls.

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

　　Article 9 The State Food and Drug Administration and the drug supervision and administration departments of provinces, autonomous regions, and municipalities shall establish a drug recall information disclosure system and use effective means to publicly disclose information on drugs with safety hazards and the status of drug recalls to society.

 

Chapter 2 Investigation and Evaluation of Drug Safety Hazards

 

　　Article 10 Drug manufacturing enterprises shall establish and improve the drug quality assurance system and adverse drug reaction monitoring system, collect and record information on drug quality issues and adverse drug reactions, and report to the drug supervision and administration department in a timely manner as prescribed.

　　Article 11 Drug manufacturing enterprises shall investigate possible safety hazards of drugs.

　　When the drug supervision and administration department conducts investigations on possible drug safety hazards, drug manufacturing enterprises shall provide assistance.

　　Drug distribution enterprises and users shall cooperate with drug manufacturing enterprises or the drug supervision and administration department in conducting investigations related to drug safety hazards and provide relevant materials.

　　Article 12 The content of drug safety hazard investigations shall be determined according to actual conditions and may include:

　　(1) Types, scope, and causes of adverse drug events that have occurred;

　　(2) Whether the drug use complies with the indications, usage, and dosage requirements specified in the drug instructions and labels;

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

　　(4) Whether drug storage and transportation meet requirements;

　　(5) Composition and proportion of the main drug user population;

　　(6) Batches, quantities, circulation areas, and scope of drugs that may have safety hazards;

　　(7) Other factors that may affect drug safety.

　　Article 13 The main contents of drug safety hazard evaluation include:

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

　　(2) The harmful impact on the main user population;

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

　　(4) The severity and urgency of the harm;

　　(5) The consequences caused by the harm.

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

　　(1) Level 1 recall: drugs that may cause serious health hazards;

　　(2) Level 2 recall: drugs that may cause temporary or reversible health hazards;

　　(3) Level 3 recall: drugs that generally do not cause health hazards but need to be recalled for other reasons.

　　Drug manufacturing enterprises shall scientifically design drug recall plans and organize implementation based on recall levels and drug sales and usage conditions.

 

Chapter 3 Voluntary Recall

 

　　Article 15 Drug manufacturing enterprises shall analyze collected information, investigate and evaluate drugs that may have safety hazards according to the requirements of Articles 12 and 13 of these measures, and decide to recall if safety hazards are found.

　　Overseas pharmaceutical manufacturers of imported drugs shall promptly report to the State Food and Drug Administration when implementing drug recalls abroad; recalls conducted domestically shall be specifically implemented by the importing entity in accordance with these measures.

　　Article 16: After making a decision to recall drugs, drug manufacturing enterprises shall formulate a recall plan and organize its implementation. Level 1 recalls must be completed within 24 hours, level 2 recalls within 48 hours, and level 3 recalls within 72 hours. They shall notify relevant drug distribution enterprises and users to stop sales and use, and report to the drug supervision and administration department of the province, autonomous region, or municipality where they are located.

　　Article 17: After initiating a drug recall, drug manufacturing enterprises shall submit the investigation and evaluation report and recall plan to the drug supervision and administration department of the province, autonomous region, or municipality where they are located for record within 1 day for level 1 recalls, within 3 days for level 2 recalls, and within 7 days for level 3 recalls. The provincial, autonomous region, or municipal drug supervision and administration department shall report the investigation and evaluation report and recall plan for level 1 drug recalls to the National Medical Products Administration.

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

　　(1) Specific information about the recalled drugs, including name, batch, and other basic information;

　　(2) Reasons for implementing the recall;

　　(3) Results of the investigation and evaluation;

　　(4) Recall classification.

　　The recall plan shall include the following content:

　　(1) Drug production and sales situation and the quantity to be recalled;

　　(2) Specific content of recall measures, including organization, scope, and time limits for implementation;

　　(3) Channels and scope for publicizing recall information;

　　(4) Expected effects of the recall;

　　(5) Handling measures after the drug recall;

　　(6) Name and contact information of the contact person.

　　Article 19: The drug supervision and administration department of the province, autonomous region, or municipality may organize experts to evaluate the recall plan submitted by drug manufacturing enterprises based on actual conditions. If it is considered that the measures taken by the drug manufacturing enterprises cannot effectively eliminate safety hazards, they may require the enterprises to take more effective measures such as expanding the recall scope or shortening the recall time.

　　Article 20: If drug manufacturing enterprises make changes to the reported recall plan, they shall promptly report to the drug supervision and administration department for record.

　　Article 21: During the implementation of the recall, drug manufacturing enterprises shall report the progress of the drug recall to the drug supervision and administration department of the province, autonomous region, or municipality where they are located daily for level 1 recalls, every 3 days for level 2 recalls, and every 7 days for level 3 recalls.

　　Article 22: Drug manufacturing enterprises shall keep detailed records of the handling of recalled drugs and report to the drug supervision and administration department of the province, autonomous region, or municipality where the enterprise is located. Drugs that must be destroyed shall be destroyed under the supervision of the drug supervision and administration department.

　　Article 23: After completing the recall, drug manufacturing enterprises shall evaluate the recall effect and submit a drug recall summary report to the drug supervision and administration department of the province, autonomous region, or municipality where they are located.

　　Article 24: The drug supervision and administration department of the province, autonomous region, or municipality shall review the summary report within 10 days of receipt and evaluate the recall effect. If necessary, experts shall be organized for review and evaluation. The conclusions of the review and evaluation shall be notified to the drug manufacturing enterprises in writing.

　　After review and evaluation, if the recall is deemed incomplete or more effective measures are needed, the drug supervision and administration department shall require the drug manufacturing enterprises to recall again or expand the recall scope.

 

Chapter 4: Ordered Recall

 

　　Article 25: After investigation and evaluation, if the drug supervision and administration department considers that there are safety hazards as referred to in Article 4 of these Measures, and the drug manufacturing enterprises should recall the drugs but have not done so voluntarily, the drug supervision and administration department shall order the drug manufacturing enterprises to recall the drugs.

　　If necessary, the drug supervision and administration department may require drug manufacturing enterprises, distribution enterprises, and users to immediately stop sales and use of the drugs.

　　Article 26: When the drug supervision and administration department makes a decision to order a recall, it shall deliver a recall order notice to the drug manufacturing enterprises. The notice shall include the following content:

　　(1) Specific information about the recalled drugs, including name, batch, and other basic information;

　　(2) Reasons for implementing the recall;

　　(3) Results of the investigation and evaluation;

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

　　Article 27: After receiving the recall order notice, drug manufacturing enterprises shall notify drug distribution enterprises and users, formulate and submit a recall plan, and organize implementation in accordance with Articles 16 and 17 of these Measures.

　　Article 28: Drug manufacturing enterprises shall report relevant information about the drug recall to the drug supervision and administration department and carry out follow-up handling of recalled drugs in accordance with Articles 20, 21, 22, and 23 of these Measures.

　　The drug supervision and administration department shall review the drug recall summary report submitted by drug manufacturing enterprises in accordance with Article 24 of these Measures and evaluate the recall effect. After review and evaluation, if the recall is deemed incomplete or more effective measures are needed, the drug supervision and administration department may require the drug manufacturing enterprises to recall again or expand the recall scope.

 

Chapter 5: Legal Liability

 

　　Article 29: If the drug supervision and administration department confirms that drug manufacturing enterprises have caused safety hazards in marketed drugs due to violations of laws, regulations, or rules, administrative penalties shall be imposed according to law. However, if the enterprises have taken recall measures to actively eliminate or mitigate the harmful consequences, penalties shall be mitigated or reduced in accordance with the Administrative Punishment Law; if the violation is minor and corrected promptly without causing harmful consequences, no penalty shall be imposed.

　　The recall of drugs by drug manufacturing enterprises does not exempt them from other legal liabilities they should bear according to law.

　　Article 30: If drug manufacturing enterprises violate these Measures by failing to voluntarily recall drugs when safety hazards are found, they shall be ordered to recall the drugs and fined three times the value of the recalled drugs; if serious consequences occur, the original issuing authority shall revoke the drug approval certificate, up to and including revocation of the Drug Manufacturing License.

　　Article 31: If drug manufacturing enterprises violate Article 25 of these Measures by refusing to recall drugs, they shall be fined three times the value of the recalled drugs; if serious consequences occur, the original issuing authority shall revoke the drug approval certificate, up to and including revocation of the Drug Manufacturing License.

　　Article 32: If drug manufacturing enterprises violate Article 16 of these Measures by failing to notify drug distribution enterprises and users to stop sales and use of drugs to be recalled within the prescribed time, they shall be warned, ordered to make corrections within a time limit, and fined up to 30,000 yuan.

　　Article 33: If drug manufacturing enterprises violate Articles 19, paragraph 2 of Article 24, and paragraph 2 of Article 28 of these Measures by failing to take corrective measures or recall drugs as required by the drug supervision and administration department, they shall be warned, ordered to make corrections within a time limit, and fined up to 30,000 yuan.

　　Article 34: If a pharmaceutical manufacturing enterprise violates the provisions of Article 22 of these Measures, it shall be warned, ordered to make corrections within a time limit, and fined up to 30,000 yuan.

　　Article 35: If a pharmaceutical manufacturing enterprise has any of the following circumstances, it shall be warned and ordered to make corrections within a time limit; if not corrected within the time limit, a fine of up to 20,000 yuan shall be imposed:

　　(1) Failure to establish a drug recall system, drug quality assurance system, and adverse drug reaction monitoring system as prescribed by these Measures;

　　(2) Refusal to assist the drug regulatory authorities in conducting investigations;

　　(3) Failure to submit investigation and evaluation reports of drug recalls, recall plans, progress reports, and summary reports of drug recalls as prescribed by these Measures;

　　(4) Changing the recall plan without filing with the drug regulatory authorities.

　　Article 36: If a drug distribution enterprise or user unit violates the provisions of Article 6 of these Measures, it shall be ordered to stop sales and use, and fined not less than 1,000 yuan and not more than 50,000 yuan; if serious consequences are caused, the original issuing authority shall revoke the "Drug Distribution License" or other licenses.

　　Article 37: If a drug distribution enterprise or user unit refuses to cooperate with the pharmaceutical manufacturing enterprise or drug regulatory authorities in conducting investigations of drug safety hazards, or refuses to assist the pharmaceutical manufacturing enterprise in recalling drugs, it shall be warned, ordered to make corrections, and may be fined up to 20,000 yuan.

　　Article 38: If the drug regulatory authorities and their staff fail to perform their duties or abuse their powers, they shall be dealt with in accordance with relevant laws and regulations.

 

Chapter 6: Supplementary Provisions

 

　　Article 39: These Measures shall be interpreted by the National Medical Products Administration.

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