Measures on the Administration of Drug Recalls
Measures on the Administration of Drug Recalls
Measures on the Administration of Drug Recalls
Order of the State Food and Drug Administration [2007] No.29
December 10, 2007
The Measures on the Administration of Drug Recalls has been adopted at the meeting of the State Food and Drug Administration on December 6, 2007 and is hereby promulgated and enters into effect as of the day of its promulgation.
Shao Mingli, Minister of the State Food and Drug Administration
Rules on Administrating Drug Recalls
Chapter I General Provisions
Article 1 In order to strengthen the supervision of drugs and protect public safety in using drugs, the present law is formulated in accordance with the Drug Administration Law of the People's Republic of China, Implementing Regulations of the Drug Administration Law of the People's Republic of China, and the Special Provisions of the State Council on Strengthening the Safety Supervision and Administration of Food and Other Products.
Article 2 Drug recalls and the supervision and administration thereof within the territory of the People's Republic of China shall be governed by the present law.
Article 3 The term "drug recall" as defined herein shall mean the recall by drug-producing enterprises (including overseas pharmaceutical factories of imported drugs, the same hereinafter) of drugs that have been put on the market yet have potential safety threats in accordance with all relevant procedures.
Article 4 A potential safety threat as mentioned above shall refer to any unreasonable danger that arises from problems in the process of development, production, etc., of the drugs and that may jeopardize human health and life.
Article 5 Drug-producing enterprises shall set up an efficient drug recall system to collect relevant information on drug safety, investigate and evaluate all drugs that may contain elements of potential threats, and recall all drugs found to be potential threats in accordance with the present law. Drug-distributing enterprises and units using drugs shall assist the drug-producing enterprises in performing their obligation of recall, delivery, and feed-back information on drug recall to the drug-producing enterprises, control, and withdrawal of the drugs found to be potential threats in accordance with the recall program.
Article 6 Where drug-distributing enterprises or units using the drugs discover that the drug they distribute or use is a potential threat to human health and safety, they shall immediately cease the distribution or use of the said drug, and inform the enterprise responsible for production or the supplier of the existence of the situation, and report the situation to departments in charge of drug supervision and administration.
Article 7 Drug-producing enterprises, drug-distributing enterprises, and units employing the use of the drugs shall establish and keep complete records of all sales and purchase of said drugs to ensure the origin of all drugs sold can be traced.
Article 8 The drug supervision and administration departments in all provinces, autonomous regions or municipalities directly under jurisdiction of the Central Government where the drug-producing enterprise that recalls drugs is located shall be responsible for the supervision and administration of the drug recall. The drug supervision and administration departments in other provinces, autonomous regions or municipalities directly under jurisdiction of the Central Government shall provide due cooperation and assistance when administering and supervising drug recall.
The State Food and Drug Administration shall supervise the administration of the drug recall throughout China.
Article 9 The State Food and Drug Administration and the drug supervision and administration departments of all provinces, autonomous regions or municipalities directly under jurisdiction of the Central Government shall establish a disclosure system for information on drug recalls and publicize information on drugs harboring potential threats and all drug recalls to the public in an efficient manner.
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