China News Service, October 26. According to the official website of the State Food and Drug Administration, on October 26, the State Food and Drug Administration issued the newly revised "Measures for the Administration of Drug Recalls" (hereinafter referred to as the "Measures"), which will take effect 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 revisions to the Measures issued in 2007, and abolished the original Measures in the State Administration for Market Regulation. ", it will be released and implemented in the form of an announcement.
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 treatment measures for recalled drugs, and compacts drug listing license holders. (hereinafter referred to as the holder) responsibility, so as to urge the holder to take the initiative to eliminate the possible hidden dangers of drug safety in the budding or initial stage, so as to better ensure the safety of public medication.
The new version of the "Measures" includes a total of 33 articles in five chapters, including General Provisions, Investigation and Evaluation, Active Recall, Ordered Recall, and Supplementary Provisions.
It is clear that the holder is the main body responsible for controlling risks and eliminating hidden dangers. Drug manufacturers, drug dealers, and drug users should actively assist. For the recall of Chinese herbal decoction pieces and Chinese herbal formula granules, their production enterprises will organize and implement them in accordance with the new version of the "Measures".
The new version of the "Measures" improves the holder's investigation and evaluation requirements for drugs that may have quality problems or other potential safety hazards, refines the holder's voluntary recall implementation procedures, and urges and guides the holder to investigate and evaluate drugs with quality problems or other potential safety hazards. Timely and proactively recalled, and earnestly fulfilled the obligation of full life cycle management of drugs.
According to the provisions of the new version of the "Measures", the holder shall voluntarily announce the drug recall information in accordance with the law. For the implementation of the first-level and second-level recalls, they shall also apply for the release of the recall information on the website of the provincial drug regulatory authority in accordance with the law, and the provincial drug regulatory authority shall The drug recall information should be linked to the website of the State Food and Drug Administration.
The disclosure of drug recall information in accordance with the law will help all sectors of society to timely, objectively and accurately understand the quality problems or other potential safety hazards of drugs, and assist and supervise the holders to implement drug recalls in accordance with laws and regulations.
The new version of the "Measures" scientifically improves the handling measures for recalled drugs, and clarifies that the labels and storage measures of recalled drugs should be clearly different from normal drugs to prevent errors and confusion; for those that need to be destroyed, the recalled drugs should be stored in the holder, drug manufacturer or storage. Destruction under the supervision of the drug regulatory department of the people's government at or above the county level or a notary agency; for those that can be eliminated by changing labels, revising and improving instructions, and repackaging, or for those that do not meet the drug standards but do not affect the safety and effectiveness If the problem can be solved by rework, etc., it can be properly dealt with before listing.
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.
If the overseas production of drugs involves the implementation of recalls in China, the agent in China designated by the overseas holder shall organize the implementation in accordance with the new version of the "Measures".
If the overseas holder implements a drug recall overseas, if it is a relevant situation after a comprehensive assessment, its domestic agent shall report to the local provincial drug regulatory authority. The overseas holder should study and judge the overseas recall. If it does not, 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 domestically produced and exported drugs.
If domestic holders are required to discover quality problems or other safety hazards in the exported drugs, they shall promptly notify the drug regulatory agency and purchaser of the importing country (region); The provisions of the procurement contract organize the implementation of recalls.
The new version of the "Measures" clarifies the management and guidance responsibilities of drug regulatory authorities at all levels for drug recall work according to law.
The provincial drug regulatory authority shall order the holder to recall if the holder should be recalled according to law but fails to recall.
If the holder refuses to recall, and if the drug manufacturer, drug distributor, or drug user does not cooperate with the recall, the corresponding provincial drug supervision department shall investigate and punish in accordance with the provisions of Article 135 of the "Drug Administration Law".
(Zhongxin Finance)