Affected all pharmaceutical companies, ushered in a major overhaul after 14 years!

On September 27, 2021, the State Food and Drug Administration announced the 72nd National Day Operation-Public Solicitation of "Drug Recall Management Measures (Draft for Comment)" (Deadline for comments: October 29, 2021)
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One year ago, on October 13, 2020, the official website of the State Food and Drug Administration released a version of the "Administrative Measures for Drug Recalls" (draft for comments) (deadline for comments: October 30, 2020)
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In order to implement the "Drug Administration Law of the People's Republic of China", "The People's Republic of China Vaccine Administration Law" and other laws and regulations, this article analyzes the background and main new and revised contents of the "Drug Recall Management Measures"
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PART 01.
Background of the Chinese version of "Drug Recall Management Measures" The safety and effectiveness of drugs are directly related to the health of the people and the harmony and stability of the society.
It is a major livelihood and public safety issue
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If a product after the market has defects and cannot be recalled and controlled in time, it may endanger the health and safety of consumers
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Therefore, the establishment and implementation of the drug recall system by the state plays an important role in controlling the risk of defective drugs after marketing, eliminating potential drug safety hazards, and protecting public safety
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Before December 10, 2007, China has not formulated corresponding legal liability clauses for the occurrence of serious adverse reactions to drugs
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The successive occurrence of drug safety incidents such as Xinfer, Qieryao, and methotrexate make the establishment of the drug recall system urgent
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Drawing on the successful experience and systems of developed market economies, the much-watched "Measures for the Administration of Drug Recalls" was formally implemented on December 10, 2007.
These measures have always run through the idea that companies are the first person responsible for drug safety, and encourage companies Actively recall drugs with potential safety hazards.
With the implementation of the newly revised "Drug Administration Law" and "Vaccine Administration Law" in 2019, the implementation of the MAH system, and the drug regulatory requirements have undergone great changes.
In order to adapt to the new regulatory requirements, the state The Food and Drug Administration initiated the revision of the "Measures for the Administration of Drug Recalls"
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PART 02.
Changes in the basic framework structure of the new and old versions of the "Drug Recall Management Measures" The framework of the 2021 version of the "Drug Recall Management Measures" is basically the same as the 2007 version.
Compared with the old version (2007 version), the total number of provisions in the 2021 version is reduced by 8.
In Chapter Two, the original "Investigation and Evaluation of Potential Drug Safety Hazards" is revised to "Investigation and Evaluation of Drug Defects"; there is no penalty chapter, that is, Chapter 5 Legal Responsibility of the old version (2007 edition) is completely deleted
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PART 03.
The new version of the "Drug Recall Management Measures" is the main new and revised content.
First look 1.
Revised the interpretation of the definition of drug recall: The definition of drug recall is based on the provisions of Article 82 of the 2019 version of the "Drug Management Law", as well as the actual drug recall situation And the handling method was revised, the "drugs with potential safety hazards that have been marketed" were revised to "the drugs with defects on the market", and "and take corresponding measures to control the activities of eliminating defects"
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Article 82 of the "Drug Administration Law": If the drug has quality problems or other safety hazards, the drug marketing authorization holder shall immediately stop the sale, inform the relevant drug dealers and medical institutions to stop the sale and use, and recall the drugs that have been sold , Disclose the recall information in a timely manner, immediately stop production when necessary, and report the drug recall and handling of the drug to the drug supervision and management department of the people's government of the province, autonomous region, and municipality directly under the Central Government and the health authority
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Pharmaceutical production enterprises, pharmaceutical trading enterprises and medical institutions shall cooperate
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If the holder of the drug marketing authorization should recall the drug in accordance with the law, but the drug is not recalled, the drug regulatory department of the people’s government of the province, autonomous region, or municipality directly under the Central Government shall order the recall
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2.
Adjusted the interpretation of the scope of drug recall: Due to improper storage and transportation, labeling and other reasons, there may be risks that affect drug safety or use.
According to the principle of preventing and controlling drug quality and safety risks, the scope of drugs that actually need to be recalled is expanded to "defects" Drugs refer to drugs that have quality problems or other safety hazards due to reasons such as research and development, production, storage and transportation, and labeling
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" 3.
Clarified the relevant requirements for the publication of drug recall information.
Interpretation: According to the relevant provisions of the Drug Administration Law The drug marketing authorization holder is responsible for the disclosure of drug recall information; the relevant requirements of the drug regulatory authority for the disclosure of recall information are clarified
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Implement the territorial supervision responsibility of the provincial drug regulatory department where the drug marketing license holder is located, and consider the severity of the health hazard caused by the defective drug to the human body.
For the implementation of the first and second drug recalls, Article 17 of this "Measures" The second paragraph and the second paragraph of Article 25 require the website of the provincial drug regulatory authority where the drug marketing authorization holder is located to publish recall information
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4.
The legal liability clauses related to drug recalls have been deleted.
Interpretation: No additional penalties will be imposed
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If the holder of the drug marketing license orders the recall but refuses to do the recall, or the drug manufacturer, drug distributor, or user unit fails to cooperate with the recall, it shall be punished in accordance with the provisions of Article 135 of the Drug Administration Law
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Article 135 If the holder of a drug marketing authorization refuses to recall after the drug regulatory authority of the people’s government of a province, autonomous region, or municipality orders the recall, a fine of five to ten times the value of the drug to be recalled shall be imposed.
; If the value of the goods is less than 100,000 yuan, it will be calculated as 100,000 yuan; if the circumstances are serious, the drug approval documents, drug production license, and drug business license shall be revoked, and the legal representative, the main person in charge, and the directly responsible person in charge shall be revoked And other responsible persons shall be fined not less than 20,000 yuan but not more than 200,000 yuan
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If a drug manufacturer, drug distributor, or medical institution refuses to cooperate with the recall, a fine of not less than 100,000 yuan but not more than 500,000 yuan shall be imposed
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5.
Clarified the relevant requirements for drug recall records.
Interpretation: Added the way that drug marketing authorization holders can choose to destroy under the supervision of the drug regulatory authority or the notary authority
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Due to the expansion of the scope of the recall, the original "Measures" did not have specific and clear disposal requirements for recalled drugs initiated for other reasons that do not need to be destroyed, and there are actual operational difficulties
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References [1]