Administrative Measures for Drug Recalls

Administrative Measures for Drug Recalls Order of the State Food and Drug Administration (No.29) The Administrative Measures for Drug Recalls, which were deliberated and adopted at the executive meeting of the State Food and Drug Administration (SFDA) on December 6th, 2007, are hereby promulgated, and shall come into force as of the date of promulgation. Director: Shao Mingli December 10th, 2007 Administrative Measures for Drug Recalls Chapter I General Provisions Article 1 For the purpose of strengthening the supervision over drug safety and safeguarding the drug use safety, these Measures are formulated in accordance with the Pharmaceutical Administration Law of the People's Republic of China , the Regulation for the Implementation of the Pharmaceutical Administration Law of the People's Republic of China and the Special Provisions of the State Council on Strengthening the Supervision and Administration of the Safety of Food and Other Products . Article 2 These Measures apply to the recalls of drugs distributed within the borders of the People's Republic of China as well as the supervision and administration thereof. Article 3 The term “drug recalls” as mentioned in these Measures refers to the recalls of marketed drugs which have hidden safety problems by drug manufacturers (including overseas drug manufacturers of imported drugs, the same below) in accordance with the prescribed procedures. Article 4 The term “hidden safety problems” as mentioned in these Measures refers to unreasonable dangers to people's health and life caused by drugs due to reasons in research & development or production. Article 5 Drug manufacturers shall establish a drug recall system in accordance with the provisions of these Measures and constantly perfect it to gather drug safety information, investigate and evaluate drugs with probable hidden safety problems and then recall drugs with hidden safety problems. Entities trading in or using drugs shall assist drug manufacturers to fulfill the obligation of drug recalls, send and feedback information related to drug recalls in a timely manner in accordance with the requirements of the recall plans, and control and take back drugs with hidden safety problems. Article 6 Where an entity trading in or using drugs finds that a drug it is currently trading in or using has any hidden safety problem, it shall immediately stop selling and using it, notify the manufacturer or supplier of the situation and report the situation to the administrative department of drug supervision. Article 7 Drug manufacturers and entities trading in or using drugs shall establish and keep integrated purchase and sale records to ensure that it is operable to trace the source of the sale of each drug. Article 8 The administrative department of drug supervision of the province, autonomous region or municipality directly under the Central Government of the place where the manufacturer of the drug to be recalled is located shall take charge of the supervision and administration work of the recall, while the administrative departments of drug supervision in other provinces, autonomous regions and municipalities directly under the Central Government shall cooperate with it and assist it to do the related work well. The SFDA shall take charge of supervising and administering drug recalls of the whole nation. Article 9 The SFDA and the administrative departments of drug supervision in all provinces, autonomous regions or municipalities directly under the Central Government shall establish a drug recall information disclosing system and take effective ways to publicize information about drugs with hidden safety problems and situation about drug recalls. Chapter II Investigation and Evaluation on Drugs' Hidden Safety Problems Article 10 Drug manufacturers shall establish a drug quality assurance system and an adverse drug reaction monitoring system to collect and record information about the quality problems and adverse reactions of drugs, and shall report such information to the administrative department of drug supervision in a timely manner in accordance with the related provisions. Article 11 A drug manufacturer shall make investigations on the possible hidden safety problems of its drugs. Drug manufacturers shall provide assistance for the investigations on drugs' possible hidden safety problems conducted by the administrative department of drug supervision. Entities trading in or using drugs shall cooperate in the investigations on possible hidden safety problems of drugs conducted by either drug manufacturers or the administrative department of drug supervision, and shall provide the related materials. Article 12 The contents of a drug hidden safety problem investigation shall be determined in light of the actual situation, and may include: 1. class, scope and reasons of an occurred adverse drug reaction incident; 2. whether the drug is used in accordance with the indications and dosage and administration as indicated in the directions or label of the drug; 3. whether the quality of the drug reaches the national standards, whether the manufacturing process of the drug satisfies GMP and other related provisions, and whether the technique used for manufacturing the drug is consistent with the approved technique; 4. whether the drug is stored and transported in accordance with the corresponding requirements; 5. composition and proportion of the major groups using the drug; 6. the batch no. and amount of the drug which may have hidden safety problems, and the areas of its circulation; and 7. other factors that may affect the safety of the drug. Article 13 The main contents of a drug hidden safe......