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NMPA issued the Administrative Measures for Drug Recalls

 Last Update: 2022-10-31
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In order to implement the requirements of laws and regulations such as the Drug Administration Law of the People's Republic of China and the Vaccine Administration Law of the People's Republic of China, the State Food and Drug Administration has organized and revised the Measures for the Administration of Drug Recalls, which are hereby promulgated and will come into effect
on November 1, 2022.
This is hereby announced
.
Annex: Measures for the Administration of Drug Recalls State Food and Drug Administration October 24, 2022 Annex Measures for the Administration of Drug Recalls 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 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 drug use.
Article 2: These Measures
apply to the recall of drugs produced and marketed within the territory of the People's Republic of China and their supervision and management.
Article 3: "Drug recall" as used in these Measures refers to activities
in which drug marketing authorization holders (hereinafter referred to as "holders") take back drugs that have quality problems or other potential safety hazards that have been marketed in accordance with prescribed procedures, and take corresponding measures to promptly control risks and eliminate hidden dangers.
Article 4: "Quality problems or other potential safety hazards" as used in these Measures refers to drugs that do not meet legally prescribed requirements due to development, production, storage, transportation, labeling, or other reasons that may endanger human health and life safety
.
Article 5: The holder is the entity responsible for controlling risks and eliminating hidden dangers, and shall establish and improve a drug recall system, collect relevant information on drug quality and safety, investigate and assess possible quality problems or other potential safety hazards, and promptly recall drugs
with quality problems or other potential safety hazards 。 Pharmaceutical manufacturing enterprises, pharmaceutical trading enterprises, and drug users shall actively assist the holder in investigating and evaluating drugs that may have quality problems or other potential safety hazards, actively cooperate with the holder in performing recall obligations, timely convey and feedback drug recall information in accordance with the recall plan, and control and withdraw drugs
with quality problems or other potential safety hazards 。 Article 6: Where pharmaceutical manufacturing enterprises, pharmaceutical trading enterprises, or drug users discover that the drugs they produce, sell, or use may have quality problems or other potential safety hazards, they shall promptly notify the holder, and when necessary, shall suspend production, release, sales, or 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 where they are located, and the information notified and reported shall be truthful
.
Article 7: Holders, pharmaceutical manufacturing enterprises, pharmaceutical trading enterprises, and drug users shall establish and implement a drug traceability system in accordance with provisions, keep complete purchase and sales records, and ensure the traceability
of listed drugs.
Article 8: 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 regions
.
The drug regulatory departments of local people's governments at the municipal and county level are responsible for cooperating with and assisting in the work related to drug recalls, and are responsible for the supervision and management of drug trading enterprises and drug use assistance recalls within the administrative region
.
The State Medical Products Administration is responsible for guiding the management of
drug recalls nationwide.
Article 9: The State Medical Products Administration and the drug regulatory departments of provincial, autonomous regional, and directly governed municipality people's governments shall, in accordance with the relevant systems for drug information disclosure, employ effective channels to release to the public drug information and recall information with quality problems or other potential safety hazards, and when necessary, notify the competent health departments at the same level of relevant information
.
The holder shall formulate a drug recall information disclosure system, and actively publish drug recall information
in accordance with law.
Chapter II: Investigation and Assessment Article 10: Holders shall actively collect and record information on drug quality problems, adverse drug reactions/incidents, and other safety risks, and conduct investigations and assessments
of possible quality problems or other potential safety hazards.
Pharmaceutical manufacturing enterprises, pharmaceutical trading enterprises, and drug use shall cooperate with the holder in conducting investigations on relevant drug quality problems or other potential safety hazards, and provide relevant materials
.
Article 11: The investigation of drugs that may have quality problems or other potential safety hazards shall be determined based on the actual situation, which may include: (1) The type, scope and cause of the adverse drug reaction/incident that has occurred; (2) Whether drug prescriptions and production processes meet the corresponding drug standards and approved production process requirements
.
(3) Whether the drug production process complies with the Good Manufacturing Practices; Whether the changes in the production process comply with the provisions of drug registration management and relevant technical guidelines for changes; (4) Whether the storage and transportation of drugs comply with the good management practices for drug sales; (5) Whether the use of drugs complies with the guiding principles for the clinical application of drugs, clinical diagnosis and treatment guidelines, drug instructions, labeling provisions, etc.
; (6) The composition and proportion of the main population using drugs; (7) The batch, quantity, circulation area and scope of drugs that may have quality problems or other potential safety hazards; (8) Other factors
that may affect the quality and safety of drugs.
Article 12: The main contents of the assessment of drugs with quality problems or other potential safety hazards include: (1) The possibility of the drug causing harm, and whether it has caused harm to human health; (2) The harmful impact on the main user groups; (3) Harmful impacts on special populations, especially high-risk groups, such as the elderly, children, pregnant women, persons with liver and kidney insufficiency, surgical patients, and so forth; (4) The seriousness and urgency of the hazard; (5) The consequences of
the harm.
Article 13: According to the severity of drug quality problems or other potential safety hazards, drug recalls are divided into: (1) First-level recall: the use of drugs may or has caused serious health hazards; (2) Second-level recall: the use of the drug may or has caused temporary or reversible health hazards; (3) Three-level recall: The use of the drug generally does not cause health hazards
, but needs to be withdrawn for other reasons.
Article 14: The holder shall form an investigation and assessment report based on the results of the investigation and assessment and the level of drug recall, and scientifically formulate a recall plan
.
The investigation and assessment report shall include the following content: (1) The specific circumstances of the recalled drugs, including basic information such as names, specifications, and batches; (2) the reasons for the recall; (3) The results of the investigation and assessment; (4) Recall level
.
The recall plan shall include the following content: (1) The production and sales of drugs and the quantity to be recalled; (2) The specific content of the recall measures, including the organization, scope, and time limit for implementation; (3) The channels and scope of publication of recall information; (4) the expected effect of the recall; (5) Measures to deal with drugs after recalls; (6) The name and contact information of the contact
person.
Chapter III: Active Recall Article 15: If, after investigation and assessment, the holder determines that there are quality problems or other potential safety hazards in the drug, it shall immediately decide and implement the recall, and at the same time release the recall information
to the public through the official website of the enterprise or drug-related industry media.
The recall information shall include the following content: drug name, specification, batch, holder, drug manufacturer, reason for recall, recall level, etc
.
Where a primary or secondary recall is carried out, the holder shall also apply for the publication of 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 law.
Drug recall information published on the websites of the drug regulatory departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall be linked
to the website of the State Medical Products Administration.
Article 16: Where the holder makes a drug recall decision, within 1 day of the first-level recall, within 3 days of the second-level recall, and within 7 days of the third-level recall, the holder shall issue a recall notice to notify the pharmaceutical manufacturing enterprise, pharmaceutical trading enterprise, drug use, etc.
, and at the same time file the investigation and assessment report, recall plan and recall notice
with the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government where it is located 。 The recall notice shall include the following content: (1) The specific circumstances of the recalled drug, including basic information such as name, specification, and batch; (2) the reason for the recall; (3) Recall level: (4) Recall requirements, such as immediate suspension of production, release, sales, and use; Forward recall notices, etc
.
(5) Recall handling measures, such as labeling the outer packaging of recalled drugs, isolation and storage measures, storage and transportation conditions, supervision and destruction, etc
.
Article 17 In the process of implementing the recall, the holder shall report the progress
of the drug recall to the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government where it is located, every 3 days for the first-level recall, every 3 days for the second-level recall, and every 7 days for the third-level recall.
During the recall process, the holder shall evaluate the effect of the recall in a timely manner, and if it is found that the recall is incomplete, it shall change the recall plan, expand the scope of the recall or re-recall
.
Where the recall plan is changed, it shall be promptly filed with the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government
where it is located.
Article 18: The holder shall clarify the labeling and storage requirements of the recalled drugs, the labeling of the outer packaging of the recalled drugs, isolation and storage measures, etc.
, shall be clearly different from normal drugs to prevent errors and confusion
.
Where special storage conditions are required, the storage conditions shall be ensured to meet the provisions during the
storage and transshipment process.
Article 19: Where recalled drugs need to be destroyed, they shall be destroyed
under the supervision of the holder, the pharmaceutical manufacturing enterprise, or the drug regulatory department or notary institution of the people's government at or above the county level where the recalled drugs are stored.
For hidden dangers that can be eliminated by changing labels, modifying and improving instructions, re-packaging, etc.
, or for Chinese medicine pieces that do not meet drug standards but have not yet affected their safety and effectiveness, and canIf the problem is solved by rework, etc.
, it can be appropriately handled before it is listed
.
Relevant treatment operations shall comply with the requirements of corresponding drug quality management practices and other requirements, and shall not extend the validity period or shelf life of
drugs.
The holder shall have a detailed record of the disposal of the recalled drug, and the record shall be kept for 5 years and not less than 1 year
after the expiration date of the drug.
Article 20: The holder shall, in accordance with Article 82 of the "Drug Administration Law", report the drug recall and handling to the drug regulatory department and the 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 recall is completed.
The holder shall explain the drug recall during the reporting period in the annual drug report
.
Article 21: Where the overseas production of drugs involves the implementation of a recall within China, the enterprise legal person designated by the overseas holder to perform the holder's obligations 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 handling 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 where it is located 。 If an overseas holder carries out a drug recall overseas and is found to fall under the following circumstances after comprehensive assessment, its domestic agent shall, within 10 working days after the overseas recall is initiated, report the name, specification, batch, reason for the recall and other information to the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government where the recall is located: (1) It is the same variety as the drug listed in China, but does not involve the specifications, batches or dosage forms of the domestic drugs; (2) sharing production lines with domestically listed drugs; (3) Others that need to be reported
to the drug regulatory departments.
The overseas holder shall comprehensively study and judge the circumstances of the overseas recall, and if it is necessary to recall within the territory of China, it shall organize the implementation of the recall in accordance with the provisions of the first paragraph of this article
.
Chapter IV Ordering a Recall Article 22 In any of the following circumstances, the drug regulatory department of the people's government of a province, autonomous region, or municipality directly under the Central Government shall order the holder to recall the drug: (1) The drug regulatory department believes that the holder should recall the drug but has not recalled it after investigation and assessment; (2) The drug regulatory department finds that the holder's recall of drugs is not complete after reviewing the results of the holder's
voluntary recall.
Article 23: Where the drug regulatory departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government order the recall of drugs, they shall publish to the public the information ordering the recall of drugs in accordance with the relevant provisions of Articles 9 and 15 of these Measures, and require the holders, pharmaceutical manufacturing enterprises, pharmaceutical trading enterprises and drug use to stop production, release, sale and use
.
The holder shall carry out the recall in accordance with the requirements of the ordered recall, and release the drug recall information
to the public in accordance with the relevant provisions of Article 15 of these Measures.
Article 24 When the drug regulatory department of the people's government of a province, autonomous region or municipality directly under the Central Government makes a decision to order a recall, it shall serve the notice of the recall order on the holder
.
The notice of ordering a recall shall include the following content: (1) The specific circumstances of the recalled drug, including basic information such as name, specification, and batch; (2) the reasons for the recall; (3) reviewing the results of evaluations and/or investigations; (4) the level of recall; (5) Recall requirements, including scope and time limit
.
Article 25: After receiving the notice of ordered recall, the holder shall, in accordance with the provisions of Articles 14 and 16 of these Measures, notify the pharmaceutical manufacturing enterprises, pharmaceutical trading enterprises and drug use, formulate and record the recall plan, and organize its implementation
.
Article 26: In the process of carrying out the recall, the holder shall report the progress
of the drug recall to 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 relevant requirements of Article 17 of these Measures.
Article 27: Holders shall make follow-up processing and records in accordance with Articles 18 and 19 of these Measures, and submit a summary report
on the drug recall 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 completing the recall and handling.
Article 28: The drug regulatory departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall conduct a review within 10 working days of receiving the summary report, evaluate the effect of the recall, and organize experts to review and evaluate
when necessary.
If it is deemed that the recall has not effectively controlled the risks or eliminated the hidden dangers, the holder shall be requested to re-recall in writing
.
Article 29 Where a holder refuses to recall a holder after being ordered to do so by ordering him to do so in violation of the provisions of these laws and regulations, or where a pharmaceutical manufacturing enterprise, pharmaceutical trading enterprise, or drug use fails to cooperate with 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 deal with it in accordance with
the provisions of Article 135 of the "Drug Administration Law".
Chapter V Supplementary Provisions Article 30 These Measures
shall apply to the recall procedures for vaccines marketed in China.
The handling requirements for the existence or suspected quality problems of vaccines shall be implemented
in accordance with the provisions of the Vaccine Administration Law.
Article 31: Where domestic holders discover that there are quality problems or other potential safety hazards in exported drugs, they shall promptly notify the drug regulatory authority and the purchaser of the importing country (region), and if it is necessary to carry out a recall overseas, it shall organize the implementation of the recall in accordance with the relevant laws and regulations of the importing country (region) and the provisions of the procurement contract
.
Article 32 The production enterprises shall implement
the recall of Chinese medicine pieces and Chinese medicine formula granules in accordance with these Measures.
Article 33: These Measures shall take effect
on November 1, 2022.

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