The new version of the Administrative Measures for Drug Recall came into force on November 1

On October 26, the State Food and Drug Administration issued a newly revised Administrative Measures for Drug Recall (hereinafter referred to as the "Measures"), which came into force
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 after the State Administration for Market Regulation 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, focuses on timely control of quality problems or other potential safety hazards, optimizes the investigation and evaluation and recall implementation procedures, scientifically improves the handling 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 embryonic or initial stage, and better protect the safety of public drug use
.

The new version of the Measures includes a total of 33 articles
in five chapters, including general provisions, investigation and assessment, voluntary recall, ordered recall, and supplementary provisions.
It is clarified that the holder is the responsible entity for controlling risks and eliminating hidden dangers, pharmaceutical manufacturers, pharmaceutical trading enterprises, and drug users shall actively assist, and the 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 requirements for the investigation and assessment of drugs that may have quality problems or other safety hazards, refines the implementation procedures for the holder's active recall, urges and guides the holder to timely and proactively recall drugs with quality problems or other safety hazards, and earnestly fulfills the obligations of drug life cycle management
.

According to the new version of the Measures, holders shall voluntarily publish drug recall information in accordance with the law, and for those who implement primary and secondary recalls, they shall also apply to publish 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 the timely, objective and accurate understanding of the quality problems or other potential safety hazards existing in drugs by all sectors of society, and assisting and supervising the holder's implementation of drug recall work
in accordance with laws and regulations.

The new version of the Measures scientifically improves the handling measures for recalled drugs, and clarifies that the labelling 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 drug regulatory department or notary public of the people's government at or above the county level where the recalled-drug is stored; For those that can eliminate hidden dangers by replacing labels, modifying and improving instructions, repackaging and other means, or for Chinese medicine pieces that do not meet drug standards but do not affect the safety and effectiveness, and the problem can be solved through rework, etc.
, they can be properly treated before being marketed
.
On the basis of adhering to the bottom line of drug safety, this reasonably reduces the burden on
enterprises.

The new version of the Measures specifically stipulates
the recall of overseas holders.
Where the production of drugs abroad involves the implementation of a recall in China, the agent designated by the overseas holder in China shall organize the implementation in accordance with the
new version of the Measures.
If the overseas holder carries out a drug recall overseas and after comprehensive assessment falls into the relevant circumstances, its domestic agent shall report to the provincial drug regulatory department where it is located, and the overseas holder shall study and judge the situation of the overseas recall, and if it is necessary to recall in China, it shall also be organized and implemented
by its domestic agent 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 the exported drug has quality problems or other potential safety hazards, 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 management and guidance responsibilities
of drug regulatory departments at all levels for drug recall work in accordance with the law.
Where the provincial-level drug regulatory department fails to recall the holder in accordance with law, it shall order the holder to recall
.
Where the holder refuses to recall, and the pharmaceutical manufacturer, pharmaceutical trading enterprise, or drug use does not cooperate with the recall, the corresponding provincial-level drug regulatory department shall investigate and deal with it in accordance with
the provisions of Article 135 of the Drug Administration Law.