Measures for the Administration of Drug Recall

 

The Measures for the Administration of Drug Recall, which were deliberated and adopted at the executive meeting of the State Food and Drug Administration on December 6, 2007, are hereby promulgated and shall come into force as of the date of promulgation.

 

 

Director Shao Mingli
December 10, 2007

 

 

 

 

 

Chapter I General Provisions
Article 1 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 in order to strengthen drug safety supervision and ensure the safety of drug use by the public.
Article 2 These Measures shall apply to the recall, supervision and administration 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 withdrawal of drugs with potential safety hazards from the market by drug manufacturers (including overseas pharmaceutical manufacturers of imported drugs, the same below) in accordance with the prescribed procedures.
Article 4 The term "potential safety hazards" as mentioned in these Measures refers to the unreasonable risks that may endanger human health and life safety of drugs due to R&D, production and other reasons.
Article 5 Pharmaceutical manufacturers shall establish and improve the drug recall system in accordance with the provisions of these Measures, collect information related to drug safety, investigate and evaluate drugs that may have potential safety hazards, and recall drugs that may have potential safety hazards.
Drug distributors and users shall assist drug manufacturers in fulfilling their recall obligations, convey and feed back drug recall information in a timely manner according to the requirements of the recall plan, and control and take back drugs with potential safety hazards.
Article 6 Where a drug handling enterprise or user discovers that there are potential safety hazards in the drugs it markets or uses, it shall immediately stop selling or using the drugs, notify the drug producing enterprise or supplier, and report to the drug regulatory department.
Article 7 Pharmaceutical producing enterprises, trading enterprises and user units shall establish and maintain complete purchase and sale records to ensure the traceability of pharmaceuticals sold.
Article 8 The drug regulatory departments of the provinces, autonomous regions and municipalities directly under the Central Government where the recalled drug manufacturers are located shall be responsible for the supervision and administration of drug recalls, and the drug regulatory departments of other provinces, autonomous regions and municipalities directly under the Central Government shall cooperate and assist in the work related to drug recalls.
The State Food and Drug Administration shall supervise the administration of drug recalls throughout the country.
Article 9 The State Food and Drug Administration and the drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government shall establish a drug recall information disclosure system, and adopt effective ways to publicize the drug information with potential safety hazards and drug recalls to the public.
Chapter II Investigation and Assessment of Hidden Drug Safety Hazards
Article 10 Pharmaceutical producing enterprises shall establish and improve a pharmaceutical quality assurance system and a monitoring system for adverse drug reactions, collect and record information on pharmaceutical quality problems and adverse drug reactions, and report to pharmaceutical supervisory and administrative departments in a timely manner as required.
Article 11 Pharmaceutical producing enterprises shall investigate the potential safety hazards of pharmaceuticals.
When the drug regulatory department conducts an investigation into the potential safety hazards of drugs, the drug producing enterprise shall provide assistance.
Pharmaceutical trading enterprises and user units shall cooperate with pharmaceutical producing enterprises or pharmaceutical supervisory and administrative departments to carry out investigations on potential drug safety hazards and provide relevant materials.
Article 12 The contents of the investigation of potential drug safety hazards shall be determined according to the actual situation, and may include:
（1） Category, scope and cause of adverse drug events;
（2） Whether the use of drugs meets the requirements of indications, usage and dosage specified in the drug manual and label;
（3） Whether the drug quality conforms to national standards, whether the drug production process conforms to GMP and other regulations, and whether the drug production is consistent with the approved process;
（4） Whether the drug storage and transportation meet the requirements;
（5） Composition and proportion of main drug users;
（6） The batch, quantity, circulation area and scope of drugs with potential safety hazards;
（7） Other factors that may affect drug safety.
Article 13 The main contents of the assessment of potential drug safety hazards include:
（1） The possibility of harm caused by the drug and whether it has caused harm to human health;
（2） Harmful impact on main users;
（3） Harmful impact on special groups, especially high-risk groups, such as the elderly, children, pregnant women, patients with liver and kidney dysfunction, surgical patients, etc;
（4） Severity and urgency of hazards;
（5） Consequences caused by hazards.
Article 14 According to the severity of potential drug safety hazards, drug recalls are divided into:
（1） Class I recall: the use of the drug may cause serious health hazards;
（2） Second level recall: the use of the drug may cause temporary or reversible health hazards;
（3） Third level recall: The use of this drug generally does not cause health hazards, but it needs to be recalled for other reasons.
Pharmaceutical manufacturers shall scientifically design and organize the implementation of pharmaceutical recall plans according to the classification of recall and the situation of pharmaceutical sales and use.
Chapter III Active Recall
Article 15 Pharmaceutical producing enterprises shall analyze the information collected, investigate and evaluate the pharmaceuticals that may have potential safety hazards in accordance with the requirements of Articles 12 and 13 of these Measures, and decide to recall the pharmaceuticals that have potential safety hazards.
If an overseas pharmaceutical manufacturer of imported drugs recalls drugs abroad, it shall report to the State Food and Drug Administration in a timely manner; In case of recall within China, the import entity shall be responsible for the specific implementation in accordance with the provisions of these Measures.
Article 16 After making a decision on drug recall, drug producing enterprises shall formulate a recall plan and organize its implementation. Within 24 hours of the first level recall, 48 hours of the second level recall, and 72 hours of the third level recall, they shall notify the relevant drug handling enterprises and users to stop selling and using drugs, and at the same time report to the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where they are located.
Article 17 After starting a drug recall, a drug manufacturer shall submit the investigation and evaluation report and the recall plan to the drug regulatory department of the province, autonomous region or municipality directly under the Central Government for the record within 1 day for the first level recall, 3 days for the second level recall and 7 days for the third level recall. The drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government shall report the investigation and evaluation report and recall plan of the first level drug recall to the State Food and Drug Administration.
Article 18 An investigation and evaluation report shall include the following contents:
（1） Details of recalled drugs, including name, batch and other basic information;
（2） Reasons for implementing the recall;
（3） Investigation and evaluation results;
（4） Recall classification.
The recall plan shall include the following contents:
（1） Production and sales of drugs and the quantity to be recalled;
（2） Specific contents of recall measures, including organization, scope and time limit of implementation;
（3） The release route and scope of recall information;
（4） Expected effect of recall;
（5） Treatment measures after drug recall;
（6） Name and contact information of the contact person.
Article 19 The drug regulatory department of a province, autonomous region or municipality directly under the Central Government may, according to the actual situation, organize experts to evaluate the recall plan submitted by the drug manufacturer. If it believes that the measures taken by the drug manufacturer cannot effectively eliminate potential safety hazards, it may require the drug manufacturer to take more effective measures such as expanding the scope of the recall and shortening the recall time.
Article 20 Pharmaceutical producing enterprises that make changes to the reported recall plan shall report to the pharmaceutical supervisory and administrative department for the record in a timely manner.
Article 21 In the process of implementing the recall, drug manufacturers shall report the progress of drug recall to the drug regulatory department of the province, autonomous region or municipality directly under the Central Government every day, every 3 days for the first level recall, and every 7 days for the third level recall.
Article 22 A drug producing enterprise shall keep detailed records of the handling of recalled drugs and report to the drug regulatory department of the province, autonomous region or municipality directly under the Central Government where the drug producing enterprise is located. Drugs that must be destroyed shall be destroyed under the supervision of the drug regulatory department.
Article 23 After the completion of the recall, drug producing enterprises shall evaluate the effect of the recall and submit a summary report on the recall to the drug regulatory department of the province, autonomous region or municipality directly under the Central Government where they are located.
Article 24 The drug regulatory department of a province, autonomous region or municipality directly under the Central Government shall, within 10 days from the date of receiving the summary report, examine the report and evaluate the effect of the recall, and if necessary, organize experts to examine and evaluate it. The conclusion of the examination and evaluation shall be notified to the drug producing enterprise in writing.
If, after examination and evaluation, it is considered that the recall is incomplete or more effective measures need to be taken, the drug regulatory department shall require the drug manufacturer to recall again or expand the scope of the recall.
Chapter IV Order to Recall
Article 25 If the drug regulatory department, after investigation and evaluation, believes that there is a potential safety hazard as mentioned in Article 4 of these Measures, and the drug producing enterprise should recall the drugs but does not voluntarily recall them, it shall order the drug producing enterprise to recall the drugs.
When necessary, the drug regulatory department may require drug producing enterprises, trading enterprises and user units to stop selling and using the drug immediately.
Article 26 When a drug regulatory department makes a decision on ordering a recall, it shall serve a notice of ordering a recall on the drug manufacturer, which shall include the following:
（1） Details of recalled drugs, including name, batch and other basic information;
（2） Reasons for implementing the recall;
（3） Investigation and evaluation results;
（4） Recall requirements, including scope and time limit.
Article 27 After receiving the notification of the recall order, the drug producing enterprise shall notify the drug handling enterprise and the user in accordance with the provisions of Articles 16 and 17 of these Measures, formulate and submit the recall plan, and organize the implementation.
Article 28 Pharmaceutical producing enterprises shall, in accordance with the provisions of Article 20, Article 21, Article 22 and Article 23 of these Measures, report to the pharmaceutical supervisory and administrative departments the relevant information about the recall of pharmaceuticals, and carry out the follow-up treatment of the recalled pharmaceuticals.
The drug regulatory department shall, in accordance with the provisions of Article 24 of these Measures, examine the drug recall summary report submitted by the drug manufacturer and evaluate the effect of the recall. If, after examination and evaluation, it is considered that the recall is incomplete or more effective measures need to be taken, the drug regulatory department may require the drug manufacturer to recall again or expand the scope of the recall.
Chapter V Legal Liabilities
Article 29 Where a drug regulatory department confirms that a drug producing enterprise has potential safety hazards for listed drugs due to its violation of laws, regulations and rules, it shall impose administrative penalties according to law. However, if the enterprise has taken recall measures to actively eliminate or mitigate the harmful consequences, it shall be given a lighter or mitigated punishment according to the provisions of the Administrative Penalty Law; If the illegal act is minor and corrected in a timely manner, and no harmful consequences are caused, no punishment shall be given.
The recall of drugs by drug producing enterprises shall not exempt them from other legal liabilities that they should bear according to law.
Article 30 If a drug manufacturer, in violation of the provisions of these Measures, fails to recall drugs on its own initiative when it finds that there are potential safety hazards in drugs, it shall be ordered to recall drugs, and a fine of three times the value of the drugs to be recalled shall be imposed; If serious consequences are caused, the original license issuing department shall revoke the drug approval certificate, or even revoke the Drug Production License.
Article 31 If a drug manufacturer, in violation of Article 25 of these Measures, refuses to recall drugs, it shall be fined three times the value of the recalled drugs; If serious consequences are caused, the original license issuing department shall revoke the drug approval certificate, or even revoke the Drug Production License.
Article 32 If a drug producing enterprise, in violation of the provisions of Article 16 of these Measures, fails to notify the drug handling enterprise and the user to stop selling and using the drugs that need to be recalled within the prescribed time, it shall be warned, ordered to make corrections within a time limit, and fined not more than 30000 yuan.
Article 33 If a drug producing enterprise violates the provisions of Article 19, paragraph 2 of Article 24, or paragraph 2 of Article 28 of these Measures and fails to take corrective measures or recall drugs as required by the drug regulatory department, it shall be warned, ordered to make corrections within a time limit, and fined not more than 30000 yuan.
Article 34 If a drug producing enterprise violates the provisions of Article 22 of these Measures, it shall be warned, ordered to make corrections within a time limit, and fined not more than 30,000 yuan.
Article 35 If a drug producing enterprise is under any of the following circumstances, it shall be given a warning and ordered to rectify within a time limit; If it fails to make corrections within the time limit, it shall be fined not more than 20000 yuan:
（1） Failing to establish a drug recall system, a drug quality assurance system and a drug adverse reaction monitoring system in accordance with these Measures;
（2） Refusing to assist the drug regulatory department in the investigation;
（3） Failing to submit the investigation and evaluation report, recall plan, progress and summary report of drug recall in accordance with these Measures;
（4） Changing the recall plan and failing to report it to the drug regulatory department for the record.
Article 36 Where a drug handling enterprise or user violates the provisions of Article 6 of these Measures, it shall be ordered to stop its sales and use and shall be fined not less than 1000 yuan but not more than 50000 yuan; If serious consequences are caused, the original license issuing department shall revoke the Drug Trade License or other licenses.
Article 37 If a drug handling enterprise or user refuses to cooperate with the drug producing enterprise or the drug regulatory department in investigating potential drug safety hazards, or refuses to assist the drug producing enterprise in recalling drugs, it shall be warned, ordered to make corrections, and may also be fined not more than 20,000 yuan.
Article 38 Where a drug regulatory department and its staff members 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 These Measures shall be interpreted by the State Food and Drug Administration.
Article 40 These Measures shall come into force as of the date of promulgation.