Public consultation on the Measures for the Administration of Drug Recalls (Draft for Comments)

Pharma Network October 14th, October 13th, the General Division of the State Drug Administration publicly solicited the opinions of the Measures for the Administration of Drug Recalls (Draft for Comments), and the draft request for comments required that drug market license holders should establish and improve the drug recall system, collect relevant information on drug safety, investigate, evaluate and recall defective drugs in a timely manner.
Attached: Measures for the Administration of Drug Recalls (Draft for Comments) Chapter I General Rules Article 1 "Purposes and Basis" In order to strengthen drug quality supervision and ensure the safety of public drug use, 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 Regulations on 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.
2 Of the People's Republic of China, these Measures shall apply to the recall and supervision and management of listed drugs within the territory of the People's Republic of China.
Article 3 "Definition of Recall and Subject of Implementation" The term "drug recall" as used in these Measures refers to the recovery of defective drugs on the market by the licensed holder of the drug in accordance with the prescribed procedures, and corresponding measures to control the elimination of defective activities.
Article 4 (Definition of Defective Drugs) The term "defective drugs" as used in these Measures refers to drugs that have quality problems or other safety hazards due to research and development, production, sale, storage, transportation, marking, etc.
5 of the State Drug Administration is responsible for guiding the supervision and management of drug recalls throughout the country.
the drug regulatory departments of the provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the supervision and administration of drug recalls by drug listing license holders within their administrative regions.
supervision and administration departments of other local people's governments at or above the county level shall be responsible for cooperating with and assisting in the relevant work of drug recalls.
Article 6 (Obligations of The Holder's Recall) The licensed holder of the drug market is the responsible subject for controlling and eliminating the defective drug, and the recall of the defective drug shall be implemented on its own initiative.
drug market license holders shall establish and improve the drug recall system, collect relevant information on drug safety, investigate and evaluate potentially defective drugs, and recall defective drugs in a timely manner.
of imported drugs involving the implementation of recalls in China, the legal persons of enterprises designated by the licensed holders of overseas drugs in China shall organize and implement them in accordance with the provisions of these Measures.
If a drug recall is only implemented outside China and does not involve domestic drug varieties or batches, the legal person of the enterprise designated by the license holder of the drug market in China shall report the relevant information to the drug regulatory department of the province, autonomous region or municipality directly under the Central Government within 5 working days of the initiation of the overseas recall.
article 7 (Production and operation units cooperate with recall obligations) Pharmaceutical production enterprises, pharmaceutical operating enterprises and medical institutions shall actively assist drug market license holders in investigating and evaluating defective drugs, actively cooperate with drug market license holders in fulfilling recall obligations, communicate and feedback drug recall information in a timely manner in accordance with the recall plan, and control and recover defective drugs.
Article 8 If a pharmaceutical production enterprise, pharmaceutical operating enterprise or medical institution discovers that the drug it produces, operates or uses may be a defective drug, it shall immediately stop producing, selling or using the drug, notify the license holder or supplier of the drug market in a timely manner, and report to the local drug supervision and administration department that the information of the notice and report must be true.
the drug supervision and administration department of the local people's government at or above the county level where the pharmaceutical business enterprise or medical institution is located shall, after receiving the report, report it to the drug supervision and administration department of the province, autonomous region or municipality directly under the central government step by step.
9 (Requirements for establishing a retrospective system) Drug listing license holders, pharmaceutical production enterprises, pharmaceutical operating enterprises and medical institutions shall establish and implement a drug traceability system in accordance with the provisions, keep a complete record of purchase and sale, and ensure the traceability of listed drugs.
Article 10 (Recall Information included in the Annual Report) Drug listing license holders shall submit the recall of drugs in the annual report of the Drug.
. 11 (Information Disclosure Requirements) Drug market license holders shall establish a system for the disclosure of drug recall information and, through the official website of the enterprise, voluntarily publish defective drug information and recalls.
a recall to a licensed holder of an overseas drug market, the defective drug recall information shall be voluntarily published on the enterprise Chinese website or on the official website of a designated enterprise legal person in China.
there is no official website, it should be published in the national media or in the local provincial media.
Chapter II Investigation and Evaluation of Drug Defects Article 12 The license holder of a drug market shall actively collect and record information on the quality of the drug or safety hazards or adverse reactions to the drug, analyze the information collected, and investigate and evaluate possible defects.
pharmaceutical production enterprises, pharmaceutical enterprises and medical institutions shall cooperate with the drug market license holders to investigate the defects of the drugs concerned and provide relevant information.
article 13 (Investigation Content) The main contents of the investigation of drugs that may be defective include: (1) the type, scope and cause of adverse drug events that have occurred; (4) whether the drug sales process conforms to the quality management norms of drug operation, (5) whether the use of drugs conforms to the requirements of the drug specification, the adaptive and usage quantities stipulated in the drug specifications and labels, (6) the composition and proportion of the main users of the drug; (7) the batch, quantity and circulation area and scope of the drug that may have safety hazards; and (8) other factors that may affect the safety of the drug.
Article 14 The main contents of the evaluation of defective drugs include: (1) the possibility of harm caused by the drug and whether it has caused harm to human health;
Article 15 (Recall Rating) According to the severity of the defect, the drug recall is divided into: (1) a first-level recall: the use of the drug may cause serious health hazards;
drug market license holders shall scientifically design and organize the drug recall plan according to the classification of the recall and the sale and use of the drug.
CHAPTER III Active Recall Article 16 (Recall Implementation) The holder of a drug listing license shall, in accordance with the provisions of Articles 12, 13 and 14 of these Measures, decide on a recall of a drug found to be defective.
drug market license holder shall, in accordance with the investigation and evaluation report, formulate a recall plan for the organization and implementation, and shall issue the drug recall information in accordance with the provisions of Article 11 (1) of these Measures.
the implementation of a first- and second-level recall, the drug recall information shall also apply for the publication of the recall information on the government website of the local province, autonomous region or municipality directly under the central government drug supervision department.
Article 17 The investigation and evaluation report shall include the following: (1) the specific circumstances of the recalled drug, including basic information such as name, specification and batch; (2) the reasons for the recall; (3) the results of the investigation and evaluation; and (4) the recall classification.
The recall plan shall include the following: (1) the production and sale of the drug and the number of recalls to be made; (2) the specific contents of the recall measures, including the organization, scope and time limit of the implementation; (3) the manner and scope of publication of the recall information; (4) the expected effect of the recall; (5) the treatment measures after the recall of the drug; and (6) the name and contact information of the contact person.
Article 18 (Recall Notice) After the drug listing license holder has formulated a recall plan, the first-level recall shall be within 1 day, the second-level recall shall be within 3 days, and the third-level recall shall be within 7 days, and the relevant drug manufacturers, drug-operating enterprises and medical institutions shall be notified to stop production, sale and use.
The recall notice shall include the following: (1) the name, specifications, batch and other basic information of the recalled drug; (2) the reasons for the recall and the results of the risk assessment; and (3) the requirements of the recall, such as the immediate suspension of the sale and use of the drug, the immediate notification of the recall to the relevant pharmaceutical operating enterprises or medical institutions, and urge it to withdraw.
article 19 (Recall Information Release) Drug listing license holders shall, in accordance with the provisions of these Measures, issue recall information to the community, including: generic name of the drug, commodity name, lot number, drug listing license holder, pharmaceutical manufacturing enterprise, cause of recall, recall grade, risk assessment results, etc.
Article 20 (Recall Effect Assessment) After the completion of the recall, the license holder of the drug shall promptly evaluate the effect of the recall, complete the summary report of the recall and report it to the drug regulatory department of the province, autonomous region or municipality directly under the Central Government.
, if the recall is not complete, it should be recalled or extended.
Article 21 (Post-Recall Treatment) The treatment of recalled drugs shall be recorded in detail by the licensed holder of the drug market, and the records shall be kept until one year after the expiration date of the drug.
needs to be destroyed, it shall be destroyed under the supervision of the drug supervision and administration department or notary department at or above the county level (city or district) where the drug is listed, where the drug market license holder is located, or where the drug is located.
If the drug safety hazard can be eliminated by relabeling, modifying and perfecting the instruction manual, repacking, etc., the above-mentioned operation shall be completed at the original production site of the drug and under the conditions of production in accordance with the requirements, and the validity period of the drug shall not be extended.
recall drug storage and transportation process should also comply with the relevant requirements of the Drug Management Code.
22 (Recall Results Report) Drug market license holders shall report the recall and handling of drugs to the drug regulatory departments and health and health authorities of provinces, autonomous regions and municipalities directly under the Central Government in accordance with the provisions of Article 82 of the Drug Administration Law.
Chapter IV Ordering a Recall Article 23 (Circumstances of Ordering a Recall) If one of the following circumstances occurs, the drug regulatory department shall order the drug market licensee to recall the drug: (1) the drug regulatory department shall, after investigation and evaluation, consider that the drug listing license holder should recall the drug that may be defective and not recalled;
Article 24 The drug regulatory department that has made the decision on the recall measures shall require the drug market license holders, pharmaceutical production enterprises, pharmaceutical enterprises and medical institutions to immediately stop the sale and use of the drug and publish the drug recall information to the public in accordance with the provisions of Article 11 (3) of these Measures.
drug market license holders shall carry out the recall in accordance with the requirements of the drug regulatory department that made the decision, and shall issue the drug recall information to the society in accordance with the provisions of these Measures.
Article 25 (Notice of Order of Recall) When the drug regulatory department makes a decision to order a recall, it shall order the recall notice to be served on the license holder of the drug market; if the holder of the drug listing license is an overseas enterprise, it shall serve on the legal person of the enterprise designated by it in China.
notice includes the following: (1) the specific circumstances of the recalled drug, including the name, specifications, batches and other basic information; (2) the reasons for the recall; (3) the results of the investigation and evaluation; and (4) the recall grade.
article 26 (Recall Implementation) After receiving the notice of order for recall, the license holder of a drug market shall notify the pharmaceutical business enterprise and medical institution in accordance with the time limit stipulated in Article 18 of these Measures, and at the same time formulate a recall plan, submit it to the provincial drug supervision and administration department, and organize its implementation.
article 27 (Investigation and Evaluation Report and Recall Plan) After the drug recall is initiated, the first-level recall shall be within 1 day, the second-level recall shall be within 3 days, and the third-level recall shall be submitted to the drug supervision and administration department of the province, autonomous region or municipality directly under the central government.
article 28 (Recall Progress Report) In the course of implementing the recall, the drug listing license holder shall report the progress of the drug recall to the drug regulatory department of the province, autonomous region or municipality directly under the Central Government on the progress of the drug recall every 3 days, and the second-level recall every 7 days.
Article 29 (Recall Results Treatment) Drug listing license holders shall submit a summary report of the drug recall to the drug regulatory department of the province, autonomous region or municipality directly under the Central Government within 5 days after the completion of the recall.
the recall records and follow-up in accordance with the provisions of Article 21 of these Measures.
Article 30 The drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government shall review the report within 10 days from the date of receipt of the summary report, evaluate the effect of the recall and, if necessary, organize experts to review and evaluate it.
recall has not effectively eliminated drug defects or controlled the risk of drugs, the drug market license holder shall be required in writing to recall.
drug market license holders shall be recalled in accordance with the requirements of the drug regulatory authority.
Article 31 of the Article 31 by-laws of the Law shall come into effect on the date of the month of the year.
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