Provisions for Drug Recall

　　(SFDA Decree No. 29)

　　The Provisions for Drug Recall was deliberated and adopted by the executive meeting of the State Food and Drug Administration on December 6, 2007 and now is issued. These Provisions shall go into effect as of the date of promulgation.

　　Commissioner: Shao Mingli

　　December 10, 2007

　　Provisions for Drug Recall

　　Chapter 1 General Provisions

　　Article 1 The Provisions are formulated with a view to strengthening supervision of drug safety to ensure the safe use of drugs for the public in accordance with Drug Administration Law of the People's Republic of China, Regulations for the Implementation of the Drug Administration Law of the People's Republic of China and Special Rules of the State Council on Strengthening the Supervision and Management of the Safety of Food and Other Products.

　　Article 2 These Provisions are applicable to recall of drugs sold within the territory of the People's Republic of China and supervision and administration of their recall.

　　Article 3 Recall of drugs mentioned in these Provisions refers to recall of drugs with safety hazards on the market by drug manufacturers (including overseas manufacturers of imported drugs, the same below) in accordance with prescribed procedures.

　　Article 4 Safety hazards mentioned in these Provisions mean unreasonable drug-related hazards to human health and life caused by problems associated with research & development, production and other factors.

　　Article 5 Drug manufacturers shall establish and improve the drug recall system according to these Provisions, collect relevant drug safety information, investigate and assess drugs with potential safety hazards and recall drugs with safety hazards.

　　Drug distributors and users shall assist drug manufacturers in fulfilling the recall obligation, transmit information and provide feedback on recall of drugs and control and take back drugs with safety hazards according to the requirements of the recall plan.

　　Article 6 Upon finding the drug it sells and uses as of safety hazards, the drug distributor or user shall stop selling or using the drug, notify the drug manufacturer or supplier and report the findings to relevant drug regulatory departments immediately.

　　Article 7 Drug manufacturers, distributors and users shall establish and keep a complete purchase and sales record to ensure the traceability of drugs sold (on the market).

　　Article 8 The local drug regulatory department of the province, autonomous region or municipality directly under the Central Government where the manufacturer of the recalled drug is located is responsible for supervising and managing recall of the drug. The drug regulatory departments of other provinces, autonomous regions or municipalities directly under the Central Government shall cooperate and assist in work relating to recall of the drug.

　　The State Food and Drug Administration shall supervise the management of recall of drugs across the country.

　　Article 9 The State Food and Drug Administration and the drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall establish the drug recall information disclosure system and publicize information about drugs with safety hazards and recall of drugs to the society in an effective way.

　　Chapter 2 Investigation and Assessment of Drug Safety Hazards

　　Article 10 Drug manufacturers shall establish and improve the drug quality assurance system and adverse drug reaction monitoring system, collect and record information relating to drug quality problems and adverse drug reactions and report the results to the drug regulatory department promptly as required.

　　Article 11 Drug manufacturers shall investigate potential safety hazards of drugs.

　　When drug regulatory departments carry out investigation of potential safety hazards of drugs, drug manufacturers shall provide assistance.

　　Drug distributors and users shall work in conjunction with drug manufacturers or drug regulatory departments to carry out investigation on safety hazards of drugs and provide relevant information.

　　Article 12 Matters covered by investigation of drug safety hazards are decided depending on the actual situation and may include:

　　(Ⅰ) Type, range and cause of adverse drug events;

　　(Ⅱ) Whether the use of drug conforms to indications, dosage and administration specified in the instruction and label;

　　(Ⅲ) Whether the drug quality meets the national standard, whether the production of the drug meets the regulations such as GMP, whether the drug is manufactured in accordance with the approved manufacturing process;

　　(Ⅳ) Whether the storage and transport of drug meet the requirement;

　　(Ⅴ) Composition and proportion of main populations using the drug;

　　(Ⅵ) Batch number, quantity and area and scope of circulation of the drug with potential safety hazards;

　　(Ⅶ) Other factors likely to affect drug safety.

　　Article 13 Assessment of drug safety hazards mainly includes:

　　(Ⅰ) Likelihood of the drug causing harms and whether it has caused harms to human health;

　　(Ⅱ) Harmful effects on main populations using the drug;

　　(Ⅲ) Harmful effects on special populations, especially high risk groups, such as the elderly, children, pregnant women, people with hepatic and renal insufficiency and surgical patients;

　　(Ⅳ) Severity and urgency of the harm;

　　(Ⅴ) Consequences caused by the harm.

　　Article 14 According to the severity of safety hazards of the drug, recalls are classified as:

　　(Ⅰ) Class 1 recall: Use of the drug may cause serious harms to health;

　　(Ⅱ) Class 2 recall: Use of the drug may cause temporary or reversible harms to health;

　　(Ⅲ) Class 3 recall: Use of the drug usually will not cause any harm to health, but the drug has to be recalled due to other reasons.

　　Drug manufacturers shall devise the drug recall plan in a scientific way and organize its implementation according to the recall classification and sales and use of the drug.

　　Chapter 3 Voluntary Recall

　　Article 15 Drug manufacturers shall analyze information collected, investigate and assess drugs with potential safety hazards according to requirements of Article 12 and Article 13 of these Provisions and recall the drugs found to have safety hazards immediately.

　　Overseas manufacturers of imported drugs who recall drugs abroad shall report the case to the State Food and Drug Administration promptly. In the case of recall inside China, the importer shall be responsible for implementing the recall according to these Provisions.

　　Article 16 After making the decision to recall the drug, the drug manufacturer shall make the recall plan and organize its implementation, notify the relevant drug distributors and users to stop selling and using the drug within 24 hours in the case of Class 1 recall, 48 hours in the case of Class 2 recall and 72 hours in the case of Class 3 recall, and at the same time report the case to the local drug regulatory department of the province, autonomous region or municipality directly under the Central Government.

　　Article 17 After starting the drug recall procedure, the drug manufacturer shall submit the investigation and assessment reports and recall plan to the local drug regulatory department of the province, autonomous region or municipality directly under the Central Government for record within 1 day in the case of Class 1 recall, 3 days in the case of Class 2 recall and 7 days in the case of Class 3 recall. The local drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall submit the received investigation and assessment reports and plan for Class 1 recall to the State Food and Drug Administration.

　　Article 18 The investigation and assessment report shall include the following items:

　　(Ⅰ) Specific information about the recalled drugs, including basic information such as name and batch number;

　　(Ⅱ) Causes of the recall;

　　(Ⅲ) Results of the investigation and assessment;

　　(Ⅳ) Class of the recall;

　　The recall plan shall include the following items:

　　(Ⅰ) Information about production and sales of the drug and quantity of the drug to be recalled;

　　(Ⅱ) Specific details of the recall measure, including organization, scope and time limit of implementation;

　　(Ⅲ) Way and scope of disclosing the recall information;

　　(Ⅳ) Expected result of the recall;

　　(Ⅴ) Post-recall measures;

　　(Ⅵ) Name and contact details of the contact person.

　　Article 19 The local drug regulatory department of the province, autonomous region or municipality directly under the Central Government may organize experts to assess the recall plan submitted by the drug manufacturer according to the actual situation, and may request the drug manufacturer to take more effective measures such as expanding the scope of recall and shortening the time of recall if it considers the measures taken by the drug manufacturer as inadequate for eliminating safety hazards effectively.

　　Article 20 In the case of changing the recall plan submitted, the drug manufacturer shall report the change to the drug regulatory department for record promptly.

　　Article 21 During implementation of the recall, the drug manufacturer shall give updates to the local drug regulatory department of the province, autonomous region or municipality directly under the Central Government on the recall progress daily in the case of Class 1 recall, every 3 days in the case of Class 2 recall and every 7 days in the case of Class 3 recall.

　　Article 22 Drug manufacturers shall keep a detailed record of handling the recalled drugs and report the results to the local drug regulatory department of the province, autonomous region or municipality directly under the Central Government. Drugs to be destroyed must be destroyed under the supervision of the drug regulatory department.

　　Article 23 After completing the recall, the drug manufacturer shall assess the effect of the recall and submit the drug recall summary report to the local drug regulatory department of the province, autonomous region or municipality directly under the Central Government.

　　Article 24 The local drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall review the summary report within 10 days of receiving it, evaluate the recall effect and organize experts to carry out review and evaluation if necessary. The drug manufacturer shall be informed of the conclusion of the review and evaluation in writing.

　　If the review and evaluation find the recall inexhaustive and that more effective measures are needed, the drug regulatory department shall require the drug manufacturer to make another round of recall or expand the scope of recall.

　　Chapter 4 Ordered Recall

　　Article 25 When the drug manufacturer doesn't take the initiative to recall the drug that is found to have safety hazards described in Article 4 of these Provisions during investigation and assessment conducted by the drug regulatory department, the drug regulatory department shall order the drug manufacturer to recall the drug.

　　The drug regulatory department may require the drug manufacturer, distributor and user to stop selling and using the drug immediately if necessary.

　　Article 26 After making the decision to order the recall, the drug regulatory department shall send the notice of ordered recall to the drug manufacturer. The notice includes the following items:

　　(Ⅰ) Specific information about the recalled drug, including basic information such as name and batch number;

　　(Ⅱ) Causes of the recall;

　　(Ⅲ) Results of the investigation and assessment;

　　(Ⅳ) Requirements for the recall, including the scope and time limit.

　　Article 27 After receiving the notice of ordered recall, the drug manufacturer shall notify the drug distributor and user according to the provisions in Article 16 and Article 17 of these Provisions, formulate and submit the recall plan and organize its implementation.

　　Article 28 The drug manufacturer shall report the relevant information of the recall to the drug regulatory department according to the provisions in Article 20, Article 21, Article 22 and Article 23 of these Provisions, and engage in subsequent handling of the recalled drug.

　　The drug regulatory department shall review the drug recall summary report submitted by the drug manufacturer according to the provisions in Article 24 of these Provisions and evaluate the recall effect. If the review and evaluation find the recall inexhaustive and that more effective measures are needed, the drug regulatory department shall require the drug manufacturer to make another round of recall or expand the scope of recall.

　　Chapter 5 Legal Responsibilities

　　Article 29 According to law, the drug regulatory department shall impose administrative punishment/sanctions on drug manufacturers that are confirmed to have caused safety hazards in drugs on the market by violating relevant laws, rules and regulations. The manufacturers who have taken active recall measures to eliminate or mitigate harmful consequences shall receive lenient or mitigated punishment; the manufacturers who have committed minor violations and made prompt corrections but have not caused any serious consequences shall be exempted from punishment.

　　The drug manufacturer who has recalled the drug shall not be exempted from other legal liabilities that it shall bear according to law.

　　Article 30 Drug manufacturers who have found safety hazards with drugs but failed to recall the drug voluntarily in violation of these Provisions shall be ordered to recall the drug and fined 3 times the value of the drugs to be recalled; for those who have caused serious consequences, their approval documents shall be withdrawn by the original certificate-issuing department, or even worse, their Drug Manufacturing Certificate shall be revoked.

　　Article 31 Drug manufacturers who refuse to recall drugs in violation of the provisions in Article 25 of these Provisions shall be fined an amount of 3 times as much as the value of the recalled drug (the drug to be recalled); for those who have caused serious consequences, their approval documents shall be withdrawn by the original certificate-issuing department, or even worse, their Drug Manufacturing Certificate shall be revoked.

　　Article 32 Drug manufacturers who fail to notify the drug distributor and user to stop selling and using the drug to be recalled within the specified time in violation of the provisions in Article 16 of these Provisions shall be warned, ordered to rectify the situation within a time limit and fined (an amount) less than 30,000 Yuan.

　　Article 33 Drug manufacturers who fail to take corrective measures or recall the drug as required by the drug regulatory department in violation of the provisions in Article 19, paragraph 2 of Article 24 and paragraph 2 of Article 28 shall be warned, ordered to rectify the situation within a time limit and fined an amount less than 30,000 Yuan.

　　Article 34 Drug manufacturers who violate the provisions in Article 22 of these Provisions shall be warned, ordered to rectify the situation within a specified period and fined an amount less than 30 thousand Yuan.

　　Article 35 Drug manufacturers shall be warned, ordered to rectify the situation within a time limit in any of the following circumstances:

　　(Ⅰ) Fail to establish the drug recall system, drug quality assurance system and adverse drug reaction monitoring system according to these Provisions;

　　(Ⅱ) Refuse to assist the drug regulatory department in carrying out investigation;

　　(Ⅲ) Fail to submit the investigation and assessment report and plan for recall of the drug, updates on the recall and summary report;

　　(Ⅳ) Fail to report the changes of the recall plan to the drug regulatory department for record.

　　If they fail to rectify within the time limit, they shall be fined not more than 20,000 Yuan.

　　Article 36 Drug distributors and users who violate the provisions in Article 6 of these Provisions shall be ordered to stop selling and using the drug and fined an amount more than 1,000 Yuan and less than 50 ,000Yuan; for those who have caused serious consequences, the original certificate-issuing department shall revoke their Drug Supply Certificate or other certificates.

　　Article 37 Drug distributors and users who refuse to cooperate with drug manufacturers or drug regulatory departments in carrying out investigation on safety hazards of drugs and refuse to assist drug manufacturers in recalling drugs shall be warned, ordered to rectify within a time limit and fined (an amount) less than 20,000 Yuan.

　　Article 38 Drug regulatory departments and their staff who fail to perform their duties or abuse their authority shall be held accountable according to relevant laws and regulations.

　　Chapter 6 Supplementary Provisions

　　Article 39 The right to interpret these Provisions resides in the State Food and Drug Administration.

　　Article 40 These Provisions shall go into effect as of the date of promulgation.