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Measures for Unannounced Inspections of Pharmaceutical and Medical Devices [Effective]
药品医疗器械飞行检查办法 [现行有效]
【法宝引证码】
 
  
Order of the China Food and Drug Administration 

中华人民共和国国家食品药品监督管理总局令

(No. 14) (第14号)

As deliberated and adopted at the executive meeting of the China Food and Drug Administration (“CFDA”) on May 18, 2015, these Measures are hereby issued and shall come into force on September 1, 2015. 《药品医疗器械飞行检查办法》已于2015年5月18日经国家食品药品监督管理总局局务会议审议通过,现予公布,自2015年9月1日起施行。
Director: Bi Jingquan 

局 长  毕井泉

June 29, 2015 2015年6月29日

Measures for Unannounced Inspections of Pharmaceutical and Medical Devices 
Chapter I General Provisions 

  药品医疗器械飞行检查办法

 

第一章 总 则

Article 1 For purposes of strengthening supervision and inspection of pharmaceutical and medical devices and enhancing safety risk prevention and control, these Measures are hereby developed in accordance with the Drug Administration Law of the People's Republic of China, the Regulations for the Implementation of the Drug Administration Law of the People's Republic of China, the Regulation on the Supervision and Administration of Medical Devices, and other relevant laws and regulations.   第一条 为加强药品和医疗器械监督检查,强化安全风险防控,根据《中华人民共和国药品管理法》、《中华人民共和国药品管理法实施条例》、《医疗器械监督管理条例》等有关法律法规,制定本办法。
Article 2 For the purpose of the Measures, unannounced inspection of pharmaceutical and medical devices means unannounced supervision and inspection over the development, production, operation, use, and other respects of pharmaceutical and medical devices carried out by food and drug administrations.   第二条 本办法所称药品医疗器械飞行检查,是指食品药品监督管理部门针对药品和医疗器械研制、生产、经营、使用等环节开展的不预先告知的监督检查。
Article 3 The CFDA shall be responsible for organizing and implementing unannounced inspections of pharmaceutical and medical devices across the country. Local food and drug administrations at all levels shall be responsible for organizing and implementing unannounced inspections of pharmaceutical and medical devices in their respective jurisdictions.   第三条 国家食品药品监督管理总局负责组织实施全国范围内的药品医疗器械飞行检查。地方各级食品药品监督管理部门负责组织实施本行政区域的药品医疗器械飞行检查。
Article 4 Unannounced inspections of pharmaceutical and medical devices shall be conducted for safety risk prevention and control, under the principles of lawfulness and independence, objectivity and impartiality, and scientific disposal.   第四条 药品医疗器械飞行检查应当遵循依法独立、客观公正、科学处置的原则,围绕安全风险防控开展。
Article 5 Inspected entities shall cooperate in the unannounced inspections of pharmaceutical and medical devices organized and implemented by food and drug administrations and may not refuse, evade, or obstruct the unannounced inspections.   第五条 被检查单位对食品药品监督管理部门组织实施的药品医疗器械飞行检查应当予以配合,不得拒绝、逃避或者阻碍。
Article 6 Food and drug administrations shall, in accordance with the requirements on publicity of government information, disclose the inspection results, and may publicize major or typical cases to the public by press release and other means.   第六条 食品药品监督管理部门应当按照政府信息公开的要求公开检查结果,对重大或者典型案件,可以采取新闻发布等方式向社会公开。
Article 7 Food and drug administrations and relevant staff members shall strictly comply with relevant laws and regulations, clean administration discipline, and work requirements, and shall not raise requirements irrelevant to inspection to the inspected entities, or disclose the relevant information of unannounced inspections, information of the informants, and the trade secrets of the inspected entities.   第七条 食品药品监督管理部门及有关工作人员应当严格遵守有关法律法规、廉政纪律和工作要求,不得向被检查单位提出与检查无关的要求,不得泄露飞行检查相关情况、举报人信息及被检查单位的商业秘密。
Chapter II Launching 

第二章 启 动

Article 8 Under any of the following circumstances, food and drug administrations may conduct unannounced inspections of pharmaceutical and medical devices:   第八条 有下列情形之一的,食品药品监督管理部门可以开展药品医疗器械飞行检查:
1. Complaint, tip-offs, or other sources of clues indicate possible quality and safety risks. (一)投诉举报或者其他来源的线索表明可能存在质量安全风险的;
2. Quality and safety risks are found in inspection. (二)检验发现存在质量安全风险的;
3. Adverse drug reaction or medical device adverse events monitoring indicates possible quality and safety risks. (三)药品不良反应或者医疗器械不良事件监测提示可能存在质量安全风险的;
4. They doubt about the veracity of the application materials. (四)对申报资料真实性有疑问的;
5. An enterprise is suspected of seriously violating the requirements of quality management standards. (五)涉嫌严重违反质量管理规范要求的;
6. An enterprise has a record of serious dishonesty. (六)企业有严重不守信记录的;
7. Any other circumstances under which unannounced inspections need to be conducted. (七)其他需要开展飞行检查的情形。
Article 9 For the implementation of unannounced inspections, an inspection plan shall be formulated, and the inspection items, time, staff composition, and method, among others, shall be specified. Investigations required to be conducted with undisclosed identity shall be specified in the inspection plan.   第九条 开展飞行检查应当制定检查方案,明确检查事项、时间、人员构成和方式等。需要采用不公开身份的方式进行调查的,检查方案中应当予以明确。
If necessary, food and drug administrations may, in conjunction with public security departments and other relevant departments, jointly carry out unannounced inspections. 必要时,食品药品监督管理部门可以联合公安机关等有关部门共同开展飞行检查。
Article 10 An inspection team dispatched by a food and drug administration shall be composed of two or more inspectors and shall be subject to the team leader responsibility system. Inspectors shall be food and drug administrative law enforcement officials, personnel who have legally obtained qualifications of inspectors, or other personnel having obtained authorization for this inspection. According to the needs of inspection work, food and drug administrations may invite experts in relevant fields to participate in the inspection work.   第十条 食品药品监督管理部门派出的检查组应当由2名以上检查人员组成,检查组实行组长负责制。检查人员应当是食品药品行政执法人员、依法取得检查员资格的人员或者取得本次检查授权的其他人员;根据检查工作需要,食品药品监督管理部门可以请相关领域专家参加检查工作。
Personnel participating in inspection shall sign statements of no conflict of interest and letter of commitment on clean and honest administration; and inspectors whose inspection activities might conflict with the interests of others shall actively propose withdrawal. 参加检查的人员应当签署无利益冲突声明和廉政承诺书;所从事的检查活动与其个人利益之间可能发生矛盾或者冲突的,应当主动提出回避。
Article 11 The inspection team shall investigate and verify the actual situation of inspected entities' implementation of the laws and regulations on the supervision of pharmaceutical and medical devices, specify the focus of on-site inspection according to the inspection plan, and offer risk management and control plan according to the risk research and judgment.   第十一条 检查组应当调查核实被检查单位执行药品和医疗器械监管法律法规的实际情况,按照检查方案明确现场检查重点,并可以根据风险研判提出风险管控预案。
Article 12 Members of the inspection team shall not inform the inspected entities of the inspection schedule or inspection contents in advance, but shall directly enter the inspection site immediately, after gathering at the designated place; shall directly carry out inspection over possible problems; and shall not disclose the progress of the inspection process, the clues of violation found, and other relevant information.   第十二条 检查组成员不得事先告知被检查单位检查行程和检查内容,指定地点集中后,第一时间直接进入检查现场;直接针对可能存在的问题开展检查;不得透露检查过程中的进展情况、发现的违法线索等相关信息。
Article 13 A food and drug administration at a higher level organizing and implementing an unannounced inspection may notify the food and drug administration at the place where the inspected entity is located at a proper time. The food and drug administration at the place where the inspected entity is located shall dispatch personnel to assist in inspection who shall obey the arrangements of the inspection team.   第十三条 上级食品药品监督管理部门组织实施飞行检查的,可以适时通知被检查单位所在地食品药品监督管理部门。被检查单位所在地食品药品监督管理部门应当派员协助检查,协助检查的人员应当服从检查组的安排。
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