Announcement of the State Food and Drug Administration on the Release of the "Measures for the Administration of Drug Recalls" (No. 92 of 2022)

 

　　In order to implement the requirements of the Drug Administration Law of the People's Republic of China, the Vaccine Administration Law of the People's Republic of China and other laws and regulations, the State Food and Drug Administration has revised the Measures for the Administration of Drug Recalls, which are hereby issued and will take effect as of November 1, 2022。 

　　Hereby announce。 

　　　　 

　　Annex: Drug recall management Measures 

　　　　 

　　　　 

　　　　                                                                                                                                              National Medical Products Administration 

　　　　                                                                                                                                          October 24, 2022 

 

 

　　附件 

 

　　                                                                                         Measures for the administration of drug recall 

 

　　Chapter I General rules 

　　Article one  These Measures are formulated in accordance with the Drug Administration Law of the People's Republic of China, the Vaccine 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 other laws and regulations in order to strengthen drug quality supervision and ensure the safety of public use of drugs。 

　　第二条  Within the People's Republic of ChinaProduction sumThe recall of listed drugs and its supervisionThese Measures shall apply to management。 

　　第三条  The term "drug recall" as mentioned in these Measures means that the holder of the drug marketing authorization (hereinafter referred to as the holder) has withdrawn the drug from the market in accordance with the prescribed procedures的Drugs with quality problems or other safety hazards, and take appropriate measures to control risks in a timely manner.Hidden danger活动。 

　　第四条  Quality problems or other safety hazards as mentioned in these Measures,It refers to the failure of a drug to meet legal requirements due to development, production, storage, transportation, labeling, etc., or other unreasonable dangers that may cause the drug to endanger human health and life safety。 

　　第五条  Holders are responsible for controlling risks and eliminating hidden dangers, shouldEstablish and improve drug recall system, collect information on drug quality and safety, possible quality problems or otherSafety hazardConduct investigation, evaluation, timely recall of quality problems or otherSafety hazardMedicine for。 

　　Drug manufacturers, drug distributors and drug users shall actively assist the holders in dealing with possible quality problems or other problemsSafety hazardInvestigate and evaluate the drugs, actively cooperate with the holder to fulfill the recall obligations, timely convey and feedback drug recall information in accordance with the recall plan, control and recover quality problems or otherSafety hazard药品。 

　　第六条  Drug manufacturers, drug distributors or drug users discover that the drugs they produce, sell or use may have quality problems or other problemsSafety hazardWhere necessary, it shall promptly notify the holder, suspend production, release, sale and use, and report to the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government, and the information notified and reported shall be true。 

　　第七条  Holders, drug manufacturers, drug distributors, and drug users shall establish and implement a drug traceability system in accordance with regulations, keep complete purchase and sale records, and ensure the traceability of listed drugs。 

　　第八条  The drug regulatory departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the supervision and administration of drug recalls within their respective administrative areas。 

　　The drug regulatory department of the local people's government at the city and county level shall be responsible for cooperating and assisting in the relevant work of drug recall, and shall be responsible for the supervision and administration of the situation of drug distributors and drug users assisting in the recall within the administrative area。 

　　The State Drug Administration is responsible for guiding the administration of drug recalls throughout the country。 

　　第九条  The State Drug Administration and the drug regulatory departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central government shall, in accordance with the relevant systems for drug information disclosure, take effective means to publicize the information and recall information of drugs with quality problems or other safety hazards to the public, and when necessary, to the health authorities at the same level主管The department reports relevant information。 

　　The holder shall formulate a drug recall information disclosure system and proactively publish drug recall information according to law。 

　　第二章  Investigation and evaluation 

　　第十条  The holder shall take the initiative to collect and record drug quality problems, adverse drug reactions/events, and other safety risk information, and investigate possible quality problems or other safety risks和评估。 

　　Drug manufacturers, drug distributors and drug users shall cooperate with the holder to investigate drug quality problems or other safety hazards, and provide relevant information。 

　　eleventh条  To investigate drugs that may have quality problems or other safety hazards, the contents of the investigation shall be determined according to the actual situation, which may include: 

　　(a) the types, scope and causes of adverse drug reactions/events that have occurred; 

　　（二）药品Prescription, production process等是否Meet the corresponding drug standards, approved production process requirements。 

　　(3) Whether the drug production process complies with the drug production quality control standards;in-processWhether the changes comply with the provisions of drug registration management and relevant technical guidelines for changes; 

　　(4) Whether the storage and transportation of the drug conform to the quality control standards of the drug trade; 

　　(5) Whether the drug is used in accordance with the guiding principles for clinical application of drugs, clinical diagnosis and treatment guidelines, drug instructions and labeling provisions; 

　　（六Composition and proportion of main drug users; 

　　（七The batch, quantity and circulation area and scope of drugs that may have quality problems or other safety hazards; 

　　(8) Other factors that may affect the quality and safety of drugs。 

　　the twelfth条  The main contents of the evaluation of drugs with quality problems or other safety hazards include: 

　　(a) the possibility of harm caused by the drug, and whether it has caused harm to human health; 

　　(2) harmful effects on the main users; 

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

　　(4) the severity and urgency of the harm; 

　　(5) The consequences caused by the harm。 

　　thirteenth条  根据药品The severity of quality problems or other safety hazards, drug recalls are divided into: 

　　(1) Class A recall: the use of the drug may or has caused serious health hazards; 

　　(2) Class II recall: the use of the drug may or has caused temporary or reversible health hazards; 

　　(3) Class III recall: The use of the drug generally does not cause health hazards, but needs to be recalled for other reasons。 

　　the fourteenth条  The holder shallAccording to the survey和Evaluate the results and the level of drug recall,Form a surveyEvaluate the report and formulate the recall plan scientifically。 

　　The investigation and evaluation report shall include the following contents: 

　　(a) the specific information of the recalled drug, including the name, specifications, batch and other basic information; 

　　(2) the reason for the recall; 

　　(3) results of investigation and evaluation; 

　　(4) Recall level。 

　　The recall plan shall include the following: 

　　(1) the production and sales of the drug and the quantity to be recalled; 

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

　　(3) the way and scope of disclosure of recall information; 

　　(4) the expected effect of the recall; 

　　(5) Handling measures after drug recall; 

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

　　第三章  Voluntary recall 

　　the fifteenth条  After investigation and evaluation, the holder determines that the drug has quality problems or other safety hazards, shall immediately decide and implement a recall, and at the same time through the company's official website or drug-related industry mediaRelease recall information to the community。The recall information shall include the following contents: drug name, specification, batch, holder, drug manufacturer, recall reason, recall level, etc。 

　　Where a first-level or second-level recall is implemented, the holder shall also apply to publish recall information on the website of the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government in accordance with the law。The drug recall information published on the website of the drug regulatory department of the people's government of a province, autonomous region or municipality directly under the Central Government shall be linked to the website of the State Drug Administration。 

　　the sixteenth条  Where the holder makes a decision on drug recall,Class A recall within 1 day，Class II recall within 3 days，Level 3 recall within 7 days，A recall notice should be issued，Notice shall be sent to drug manufacturers, drug distributors, drug users, etc，At the same time, the investigation and evaluation report, recall plan and recall notice shall be filed with the drug regulatory department of the provincial, autonomous region and municipality directly under the Central government。The recall notice shall include the following: 

　　(a) the specific information of the recalled drug, including the name, specifications, batch and other basic information; 

　　(2) The cause of the recall; 

　　（三）Recall level: 

　　（四Recall requirements, such as immediate suspension of production, release, sale and use;Forward recall notices, etc。 

　　（五Recall handling measures, such as recall drug packaging labels, isolation storage measures, storage and transportation conditions, supervision and destruction。 

　　the seventeenth条  In the process of implementing the recall, the holder shall report the progress of the drug recall to the drug regulatory department of the local province, autonomous region and municipality directly under the Central Government every day, every 3 days and every 7 days for the first-level recall。 

　　During the recall process, the holder shall evaluate the effect of the recall in a timely manner, and if the recall is not complete, it shall change the recall plan, expand the scope of the recall or re-recall。Any change to the recall plan shall be filed with the drug regulatory department of the local province, autonomous region or municipality directly under the Central Government in a timely manner。 

　　the eighteenth条  The holder shall clarify the identification and storage requirements of the recalled drug, the outer packaging identification of the recalled drug, the isolation storage measures, etc., should be clearly different from normal drugs to prevent mistakes and confusion。Where special storage conditions are required, the storage conditions shall be ensured in the course of storage and transfer。 

　　the nineteenth条  If a recalled drug needs to be destroyed, it shall be destroyed under the supervision of the holder, the drug manufacturer, or the drug regulatory department of the people's government at or above the county level or a notarial institution in the place where the recalled drug is stored。 

　　For hidden dangers that can be eliminated by changing labels, modifying and improving instructions, and re-packaging, or for TCM decoction pieces that do not meet drug standards but do not affect the safety and effectiveness, and can solve the problem through rework and other ways, they can be appropriately treated before being marketed。The relevant treatment operations shall comply with the requirements of the corresponding drug quality management norms, and shall not extend the validity or shelf life of the drug。 

　　The holder shall have detailed records of the treatment of the recalled drug, and the records shall be kept for 5 years and not less than 1 year after the expiration date of the drug。 

　　the twentieth条  The holder shall, in accordance with Article 82 of the Drug Administration Law, report the drug recall and treatment to the drug regulatory department and the competent health department of the people's government of the province, autonomous region or municipality directly under the Central Government within 10 working days after the completion of the recall。 

　　The holder shall be listed in the annual drug report说明Drug recalls during the reporting period。 

　　the twenty-first条  Drugs produced abroad involve recall in China，The enterprise legal person designated by the overseas holder to perform the obligations of the holder within the territory of China (hereinafter referred to as the domestic agent) shall organize the implementation of the recall in accordance with these Measures，And report the drug recall and disposal to the drug regulatory department and the competent health department of the people's government of the province, autonomous region and municipality directly under the Central government where the drug is located。 

　　The overseas holder carries out drug recall abroad，After comprehensive assessment, it is considered to fall under the following circumstances:其The domestic agent shall, within 10 working days after the overseas recall is initiated, report the name, specification, batch, cause of recall and other information of the recalled drug to the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government: 

　　(1) the drug is of the same variety as the drug listed in China, but does not involve the domestic drug specifications, batches or dosage forms; 

　　(2) Sharing production lines with domestic listed drugs; 

　　(3) Other matters that need to be reported to the drug regulatory department。 

　　The overseas holder shall comprehensively study and judge the overseas implementation of the recall, if necessary中国In case of domestic recall, the recall shall be organized in accordance with the provisions of the first paragraph of this article。 

　　第四章  Ordered recall 

　　the twenty-second条  Under any of the following circumstances, the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government shall order the holder to recall the drug: 

　　(1) The drug regulatory department, after investigation and evaluation, considers that the holder should recall the drug but fails to do so; 

　　(2) The drug regulatory department, after reviewing the results of the holder's active recall, considers that the holder's recall of the drug is not thorough。 

　　the twenty-third条  Drug regulatory departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central GovernmentOrdered recall药品In accordance with Article 9 of these Measures,Article 15The relevant provisions publicize the information of ordered recalled drugs to the public, and require the holders, drug manufacturers, drug distributors and drug users to stopProduction, release,Sales and use。 

　　The holder shall recall in accordance with the ordered requirements实施召回，并Release drug recall information to the public in accordance with the relevant provisions of Article 15 of these Measures。 

　　twenty-fourth条  Drug regulatory departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central GovernmentWhere a decision on ordering a recall is made, the notice of ordering a recall shall be served on the holder。The notice of ordered recall shall include the following contents: 

　　(a) the specific information of the recalled drug, including the name, specifications, batch and other basic information; 

　　(2) the reason for the recall; 

　　（三）Review evaluation and/orSurvey and evaluation results; 

　　(4) the level of recall; 

　　(5) Recall requirements, including scope and time limit, etc。 

　　the twenty-fifth条  After receiving the notice of ordered recall, the holder shall, in accordance with the provisions of Article 14 and Article 16 of these Measures, notify the drug manufacturer, drug distributor and drug user to formulate,备案Recall plan and organize implementation。 

　　the twentieth六条  In the process of implementing the recall, the holder shall comply withThese measuresArticle 17 The relevant requirements shall report the progress of drug recall to the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central government。 

　　the twentieth七条  The holder shall do a good job of follow-up processing and records in accordance with the provisions of Article 18 and Article 19 of these Measures, and submit a summary report of drug recall to the drug regulatory department and the competent health department of the people's government of the province, autonomous region and municipality directly under the Central government within 10 working days after the completion of the recall and processing。 

　　the twenty-eighth条  省The drug regulatory department of the people's government of the autonomous region or municipality directly under the Central Government shall, within 10 working days from the date of receipt of the summary report, conduct a review and evaluate the recall effect, and organize experts to conduct a review and evaluation if necessary。If it is considered that the recall has not effectively controlled the risk or eliminated the hidden danger, it shall request the holder to recall again in writing。 

　　the twenty-ninth条  The holder violates the provisions of these Measures，Refusing to recall the drug after being ordered to do so by the drug regulatory department of the province, autonomous region or municipality directly under the Central Government where it is located，Drug producing enterprises, drug trading enterprises or drug users do not cooperate in the recall，The drug regulatory department of the people's government of the corresponding province, autonomous region or municipality directly under the Central Government shall investigate and handle the matter in accordance with the provisions of Article 135 of the Drug Administration Law。 

　　第五章  附  则 

　　the thirtieth条  These Measures shall apply to the recall procedures of vaccines listed in China。The disposal requirements for the existence or suspected existence of quality problems of vaccines shall be implemented in accordance with the provisions of the Vaccine Administration Law。 

　　the thirty-first条  Domestic holder discoveryPharmaceutical exportThere are quality problems or other safety hazards的，The drug regulatory authority of the importing country (region) and the purchaser shall be notified in a timely manner.需要If the recall is carried out overseas, the recall shall be organized in accordance with the relevant laws and regulations of the importing country (region) and the provisions of the procurement contract。 

　　the thirty-second条  The recall of Chinese medicine decoction pieces and Chinese medicine formula particles shall be carried out by the production enterprises in accordance with these Measures。 

　　the thirty-third条  These measures are from2022年11月1Diurnal effect。