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I.
What is the background of the revision of the Administrative Measures for Drug Recalls (hereinafter referred to as the "Measures")?
What is the background of the revision of the Administrative Measures for Drug Recalls (hereinafter referred to as the "Measures")?
Drug recall system is a risk management measure for post-market safety supervision of drugs, which is a risk management measure for drugs with quality problems or other potential safety hazards, by withdrawing or taking corrective measures for drugs that may have potential risks to human health on the market, the potential adverse effects that drugs may cause to the public are minimized, and the spread of quality problems or safety hazards is avoided and greater harm
is avoided 。 The original Measures were promulgated by the former Food and Drug Administration in December 2007 and have played an active role
in strengthening drug safety risk management in a timely and effective manner over the past 10 years.
is avoided 。 The original Measures were promulgated by the former Food and Drug Administration in December 2007 and have played an active role
in strengthening drug safety risk management in a timely and effective manner over the past 10 years.
In recent years, with the implementation of the newly revised Drug Administration Law and the newly formulated Vaccine Administration Law, the drug marketing authorization holder (hereinafter referred to as the holder) system has been implemented, and the drug regulatory requirements have undergone great changes
.
In order to further strengthen drug quality supervision, strengthen drug risk management, implement the main responsibility of holders, and ensure the safety of public drug use, it is necessary to revise and improve
drug recall and its management.
.
In order to further strengthen drug quality supervision, strengthen drug risk management, implement the main responsibility of holders, and ensure the safety of public drug use, it is necessary to revise and improve
drug recall and its management.
II.
What is the main idea of the revision?
What is the main idea of the revision?
Implement the relevant provisions of the Drug Administration Law and the Vaccine Administration Law, combine the actual development of the industry, adhere to the principles of risk management and whole-process control, optimize the investigation and evaluation and recall implementation procedures around the timely control of quality problems or other potential safety hazards, scientifically improve the treatment measures of recalled drugs, and consolidate the responsibilities of holders, etc.
, to further standardize the work related to
drug recalls.
, to further standardize the work related to
drug recalls.
These Measures highlight the main responsibility of the holder, and adjust the implementation entity of the recall from the pharmaceutical manufacturer to the holder in accordance with the law; further refine the scope of drug recalls; more operational handling requirements for recalled drugs; Strengthen the connection between drug recalls and drug traceability, information disclosure and other related work; Make corresponding provisions
for the implementation of drug recalls abroad.
for the implementation of drug recalls abroad.
3.
Which drugs need to be recalled?
Which drugs need to be recalled?
Drug recall refers to the activity
of the holder to withdraw drugs that have quality problems or other potential safety hazards on the market in accordance with the prescribed procedures, and take corresponding measures to control risks and eliminate hidden dangers in a timely manner.
Among them, quality problems or other potential safety hazards refer to drugs that do not meet statutory requirements due to development, production, storage, transportation, labeling, etc.
, or other unreasonable dangers
that may make drugs endanger human health and life safety.
Including drug development, production, storage, transportation, labeling and other reasons, does not meet the requirements of current drug quality management practices such as Good Manufacturing Practice (GMP), "Good Manufacturing Practice (GSP)", as well as quality problems or other safety hazards
caused by imperfect labeling instructions.
Drugs that have evidence to prove that they may endanger human health and are sealed or seized by the drug regulatory authorities in accordance with the provisions of the Drug Administration Law are not within the scope of
recall under these Measures.
of the holder to withdraw drugs that have quality problems or other potential safety hazards on the market in accordance with the prescribed procedures, and take corresponding measures to control risks and eliminate hidden dangers in a timely manner.
Among them, quality problems or other potential safety hazards refer to drugs that do not meet statutory requirements due to development, production, storage, transportation, labeling, etc.
, or other unreasonable dangers
that may make drugs endanger human health and life safety.
Including drug development, production, storage, transportation, labeling and other reasons, does not meet the requirements of current drug quality management practices such as Good Manufacturing Practice (GMP), "Good Manufacturing Practice (GSP)", as well as quality problems or other safety hazards
caused by imperfect labeling instructions.
Drugs that have evidence to prove that they may endanger human health and are sealed or seized by the drug regulatory authorities in accordance with the provisions of the Drug Administration Law are not within the scope of
recall under these Measures.
4.
How is the drug recall carried out?
How is the drug recall carried out?
Drug recalls are divided into active recalls and ordered recalls, mainly with the active recall of the holder, supplemented
by the regulatory authorities ordering recalls.
The holder is the responsible entity for controlling drug risks and eliminating hidden dangers, and active recall is an important part of the holder's obligation to fulfill the life cycle management of
drugs.
The holder shall collect relevant information on the quality and safety of drugs, investigate and assess possible quality problems or other potential safety hazards, and if problems and hidden dangers are found, they shall take the initiative to
recall.
Pharmaceutical manufacturing enterprises, pharmaceutical trading enterprises, and drug use shall actively assist
.
The manufacturer of Chinese medicine pieces shall fulfill the relevant obligations of the holder, the quality supervision of Chinese medicine formula granules shall be included in the scope of Chinese medicine pieces management, and the recalls of Chinese medicine pieces and Chinese medicine formula granules shall be implemented
by their manufacturers in accordance with these Measures.
by the regulatory authorities ordering recalls.
The holder is the responsible entity for controlling drug risks and eliminating hidden dangers, and active recall is an important part of the holder's obligation to fulfill the life cycle management of
drugs.
The holder shall collect relevant information on the quality and safety of drugs, investigate and assess possible quality problems or other potential safety hazards, and if problems and hidden dangers are found, they shall take the initiative to
recall.
Pharmaceutical manufacturing enterprises, pharmaceutical trading enterprises, and drug use shall actively assist
.
The manufacturer of Chinese medicine pieces shall fulfill the relevant obligations of the holder, the quality supervision of Chinese medicine formula granules shall be included in the scope of Chinese medicine pieces management, and the recalls of Chinese medicine pieces and Chinese medicine formula granules shall be implemented
by their manufacturers in accordance with these Measures.
Drug regulatory departments at all levels perform corresponding regulatory duties
.
According to the Drug Administration Law, the provincial drug regulatory department shall order the holder to recall if it should be recalled according to law but has not
recalled.
.
According to the Drug Administration Law, the provincial drug regulatory department shall order the holder to recall if it should be recalled according to law but has not
recalled.
5.
How do overseas holders carry out recalls?
How do overseas holders carry out recalls?
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 obligations of the holder in China (hereinafter referred to as the domestic agent) shall organize the implementation in accordance with these Measures and perform the corresponding reporting requirements
.
.
If an overseas holder carries out a drug recall overseas and is found to be under the following circumstances after comprehensive assessment, its domestic agent shall report the name, specification, batch, reason for the recall and other information to the local provincial-level drug regulatory department within 10 working days after the overseas recall is initiated:
(1) It is the same variety as a domestically listed drug, but does not involve the specifications, batches, or dosage forms of domestic drugs;
(2) sharing production lines with domestically listed drugs;
(3) Others that need to be reported
to the drug regulatory departments.
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 be organized and implemented
by its domestic agent in accordance with these Measures.
by its domestic agent in accordance with these Measures.
6.
How should the recalled drugs be handled?
How should the recalled drugs be handled?
The holder shall clearly define the identification and storage requirements of the recalled drugs, and the relevant labels and storage measures shall be clearly different from normal drugs, and if special storage is required, it shall also ensure that the requirements
are met in storage and transit.
are met in storage and transit.
Where the 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 at or above the county level or notary public where the recalled drugs are stored.
That is, the holder can choose to destroy under the supervision of the local drug regulatory department or notary public according to his own reality, and does not need to take back the drugs circulating nationwide to the holder's location for destruction, so as to reduce unnecessary storage and transportation costs
.
under the supervision of the holder, the pharmaceutical manufacturing enterprise, or the drug regulatory department at or above the county level or notary public where the recalled drugs are stored.
That is, the holder can choose to destroy under the supervision of the local drug regulatory department or notary public according to his own reality, and does not need to take back the drugs circulating nationwide to the holder's location for destruction, so as to reduce unnecessary storage and transportation costs
.
In principle, recalled drugs can no longer be marketed
.
However, if hidden dangers 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 do not affect their safety and effectiveness, and can be solved by rework, etc.
, they can be dealt with in an appropriate way before being marketed
.
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.
.
However, if hidden dangers 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 do not affect their safety and effectiveness, and can be solved by rework, etc.
, they can be dealt with in an appropriate way before being marketed
.
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.
7.
What are the requirements for the disclosure of drug recall information?
What are the requirements for the disclosure of drug recall information?
The holder shall proactively publish drug recall information in accordance with the provisions of the Drug Administration Law on the unified publication system for drug safety information
.
When the holder makes a drug recall decision, it shall release the recall information
to the public through the official website of the enterprise or the drug-related industry media in accordance with law.
According to the level of drug recall, if a first- or second-level recall is carried out, the holder shall also apply to publish the recall information
on the website of the local provincial-level drug regulatory department in accordance with law.
Drug recall information released by provincial-level drug regulatory departments shall be linked
to the website of the State Medical Products Administration.
.
When the holder makes a drug recall decision, it shall release the recall information
to the public through the official website of the enterprise or the drug-related industry media in accordance with law.
According to the level of drug recall, if a first- or second-level recall is carried out, the holder shall also apply to publish the recall information
on the website of the local provincial-level drug regulatory department in accordance with law.
Drug recall information released by provincial-level drug regulatory departments shall be linked
to the website of the State Medical Products Administration.
The recall information published by the holder shall include the following contents: drug name, specification, batch, holder, drug manufacturer, reason for recall, recall level, etc
.
The holder may, on the basis of the necessary text descriptions, voluntarily publish the recall information
in a concise and clear form in a tabular form.
.
The holder may, on the basis of the necessary text descriptions, voluntarily publish the recall information
in a concise and clear form in a tabular form.
Through more than 10 years of drug recall and management practices, all provincial drug regulatory departments and the national drug administration have established a "product recall" column
on the websites.
In accordance with the relevant requirements of these Measures, the product recall column will continue to play a role, and relevant recall information
will be published or linked in accordance with the law.
on the websites.
In accordance with the relevant requirements of these Measures, the product recall column will continue to play a role, and relevant recall information
will be published or linked in accordance with the law.
