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On October 26, the State Food and Drug Administration issued a newly revised "Measures for the Administration of Drug Recalls" (hereinafter referred to as the "Measures"), which will come into effect
on November 1.
on November 1.
In order to better implement 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 organized the revision of the Measures issued and implemented in 2007, and issued them in the form of an announcement for implementation
after the SAMR abolished the original Measures 。 The new version of the Measures combines the actual development of the industry, adheres to the principles of risk management and whole-process control, optimizes the investigation and evaluation and recall implementation procedures around the timely control of quality problems or other potential safety hazards, scientifically improves the treatment measures for recalled drugs, and compacts the responsibilities of drug marketing authorization holders (hereinafter referred to as "holders"), so as to urge holders to take the initiative to eliminate possible drug safety hazards in the bud or at the initial stage, so as to better protect the safety of
public drug use.
after the SAMR abolished the original Measures 。 The new version of the Measures combines the actual development of the industry, adheres to the principles of risk management and whole-process control, optimizes the investigation and evaluation and recall implementation procedures around the timely control of quality problems or other potential safety hazards, scientifically improves the treatment measures for recalled drugs, and compacts the responsibilities of drug marketing authorization holders (hereinafter referred to as "holders"), so as to urge holders to take the initiative to eliminate possible drug safety hazards in the bud or at the initial stage, so as to better protect the safety of
public drug use.
The new version of the Measures includes 33 articles
in five chapters, including General Provisions, Investigation and Assessment, Active Recall, Ordered Recall, and Supplementary Provisions.
It is clear that the holder is the responsible entity for controlling risks and eliminating hidden dangers, pharmaceutical manufacturing enterprises, pharmaceutical trading enterprises, and drug use shall actively assist, and its production enterprises shall organize and implement the recall of Chinese medicine pieces and
Chinese medicine formula granules in accordance with the new version of the "Measures".
The new version of the Measures improves the holder's investigation and assessment requirements for drugs that may have quality problems or other potential safety hazards, refines the implementation procedures for the holder's active recall, urges and guides the holder to timely and actively recall drugs with quality problems or other potential safety hazards, and earnestly fulfills the obligations of the whole life cycle management of
drugs.
in five chapters, including General Provisions, Investigation and Assessment, Active Recall, Ordered Recall, and Supplementary Provisions.
It is clear that the holder is the responsible entity for controlling risks and eliminating hidden dangers, pharmaceutical manufacturing enterprises, pharmaceutical trading enterprises, and drug use shall actively assist, and its production enterprises shall organize and implement the recall of Chinese medicine pieces and
Chinese medicine formula granules in accordance with the new version of the "Measures".
The new version of the Measures improves the holder's investigation and assessment requirements for drugs that may have quality problems or other potential safety hazards, refines the implementation procedures for the holder's active recall, urges and guides the holder to timely and actively recall drugs with quality problems or other potential safety hazards, and earnestly fulfills the obligations of the whole life cycle management of
drugs.
According to the new version of the Measures, the holder shall take the initiative to publish drug recall information in accordance with the law, and for the implementation of the primary and secondary recalls, it shall also apply to publish the recall information on the website of the local provincial drug regulatory department in accordance with the law, and the drug recall information released by the provincial drug regulatory department shall be linked
to the website of the State Food and Drug Administration.
The lawful disclosure of drug recall information is conducive to a timely, objective and accurate understanding of the quality problems or other potential safety hazards of drugs in a timely, objective and accurate manner, and assisting and supervising the holders to carry out drug recall work
in accordance with laws and regulations.
to the website of the State Food and Drug Administration.
The lawful disclosure of drug recall information is conducive to a timely, objective and accurate understanding of the quality problems or other potential safety hazards of drugs in a timely, objective and accurate manner, and assisting and supervising the holders to carry out drug recall work
in accordance with laws and regulations.
The new version of the Measures scientifically improves the treatment measures for recalled drugs, clarifying that the labeling and storage measures of recalled drugs should be clearly different from normal drugs to prevent errors and confusion; Where destruction is required, it 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 drug is 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 affected safety and effectiveness, and the problem can be solved through rework, etc.
, they can be appropriately treated before being marketed
.
On the basis of adhering to the bottom line of drug safety, this reasonably reduces the burden on
enterprises.
, or for Chinese medicine pieces that do not meet drug standards but have not affected safety and effectiveness, and the problem can be solved through rework, etc.
, they can be appropriately treated before being marketed
.
On the basis of adhering to the bottom line of drug safety, this reasonably reduces the burden on
enterprises.
For the recall of overseas holders, the new version of the Measures provides specific provisions
.
Where the overseas production of drugs involves the implementation of a recall within China, the agent designated by the overseas holder in China shall organize and implement
it in accordance with the new version of the Measures.
If the overseas holder carries out a drug recall abroad, and after comprehensive assessment, it is a relevant situation, the domestic agent shall report to the local provincial drug regulatory department, and the overseas holder shall study and judge the overseas recall, and if it needs to be recalled in China, its domestic agent shall also organize the implementation in accordance with the new version of the
Measures.
.
Where the overseas production of drugs involves the implementation of a recall within China, the agent designated by the overseas holder in China shall organize and implement
it in accordance with the new version of the Measures.
If the overseas holder carries out a drug recall abroad, and after comprehensive assessment, it is a relevant situation, the domestic agent shall report to the local provincial drug regulatory department, and the overseas holder shall study and judge the overseas recall, and if it needs to be recalled in China, its domestic agent shall also organize the implementation in accordance with the new version of the
Measures.
The new version of the Measures also clarifies
the recall of drugs produced and exported in China.
If the domestic holder discovers that there are quality problems or other potential safety hazards in the exported drugs, it 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 abroad, 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
.
the recall of drugs produced and exported in China.
If the domestic holder discovers that there are quality problems or other potential safety hazards in the exported drugs, it 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 abroad, 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
.
The new version of the Measures clarifies the responsibilities
of drug regulatory departments at all levels for the management and guidance of drug recall work in accordance with the law.
If the provincial drug regulatory department fails to recall the holder according to law, it shall order the holder to recall
.
If the holder refuses to recall, the pharmaceutical manufacturing enterprise, the pharmaceutical trading enterprise, or the use of the drug does not cooperate with the recall, the corresponding provincial drug regulatory department shall investigate and deal with it in accordance with
the provisions of Article 135 of the Drug Administration Law.
of drug regulatory departments at all levels for the management and guidance of drug recall work in accordance with the law.
If the provincial drug regulatory department fails to recall the holder according to law, it shall order the holder to recall
.
If the holder refuses to recall, the pharmaceutical manufacturing enterprise, the pharmaceutical trading enterprise, or the use of the drug does not cooperate with the recall, the corresponding provincial drug regulatory department shall investigate and deal with it in accordance with
the provisions of Article 135 of the Drug Administration Law.
