欧盟托管法案（EU）20171569临床试验药GMP原则和指南
COMMISSION DELEGATED REGULATION (EU) 2017/1569
of 23 May 2017霸气的壁纸
supplementing Regulation (EU) No 536/2014 of the EuropeanParliament and of the Council by specifying principles of and guidelines forgood manufacturing practice for investigational medicinal products for humanu and arrangements for inspections
(Text with EEA relevance)党支部鉴定意见
欧盟托管法案（EU）2017/1569 2017年5月23日
补充欧洲议会和欧盟委员会法规（EU）No.536/2014说明人用临床试验用药GMP原则和指南以及检查安排
THEEUROPEAN COMMISSION,
欧盟委员会
Havingregard to the Treaty on the Functioning of the European Union,
关于欧盟职能条约
Havingregard to Regulation (EU) No 536/2014 of the European Parliament and of theCouncil of 16 April 2014 on clinical trials on medicinal products for humanu, and repealing Directive 2001/20/EC[1],and in particular Article 63(1) thereof,
关于欧盟议会和委员会2014年4月16日关于人用临床试验用药的法规（EU）536/2014，以及即将废止的指令2001/20/EC，尤其是其中第63（1）条
Whereas: 鉴于
(1) The good manufacturing practice forinvestigational medicinal products for human u ensures that there isconsistency between batches of the same investigational medicinal product udin the same or different clinical trials, and that changes during thedevelopment of an investigational medicinal product are adequately documentedand justified. The manufacturing of investigational medicinal products prentsadditional chall
enges comparing to the manufacturing of authorid medicinal productsbecau there are no fixed routines, there is a variety of clinical trialdesigns and conquently packaging designs. Tho challenges are due to theneed, often, of randomisation and to disgui the identity of theinvestigational medicinal products for the purpo of clinical trial(blinding). The toxicity, potency and nsitising potential of investigationalmedicinal products for human u may not be fully understood at the time of thetrial, and the need to minimi all risks of cross-contamination is thereforeof even greater importance than for authorid medicinal products. Becau ofthis complexity, the manufacturing operations should be subject to a highlyeffective pharmaceutical quality system. 学习计划500字
人用临床试验用药GMP确保了用于相同或不同临床试验中的同种临床试验用药批次间的一致性，确保在临床试验用药研发期间的变更具有充分的记录和论证。相比于已批准的药品生产，临床试验用药的生产呈现出更多的挑战性，因为其并无固定的常规操作，临床试验设计会有变化，而包装设计也相应有变化。这些挑战通常是由于随机选择的需要，以及在临床试验中区分临床试验用药（加盲）的需要而产生的。人用临床试验药品的毒性、效价和潜在过敏性可能在试验时期并不能完全了解，因而降低交叉污染的所有风险的需求相比
于已批准的药品会更为重要。鉴于此种复杂性，生产操作应在高效药物质量体系的管理之下。
(2) Good manufacturing practice as regards bothmedicinal products authorid to be placed on the market and investigationalmedicinal products are bad on the same principles. The same manufacturingsites will often manufacture both investigational and medicinal productsauthorid to be placed on the market. For that reason the principles andguidelines of good manufacturing practice for investigational medicinalproducts for human u should be aligned as much as possible with thoapplicable to medicinal products for human u.
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丝瓜做法已批准将要上市的药品和临床试验用药品的优良生产规范是基于相同原则的。相同的生产场所通常既生产临床试验药品，也生产已批准销售的药品。因此，人用临床试验药品的优良生产规范原则和指南应尽可能与适用于人用药品的原则和指南保持一致。
(3) In accordance with Article 61(5) ofRegulation (EU) No 536/2014 certain process do not require the authorisationreferred to in Article 61(1) of that Regulation. In line with Articl
e 63(2) ofRegulation (EU) No 536/2014 good manufacturing practice for investigationalmedicinal products does not apply to tho process.
依据法规（EU）536/2014第61（5）条，有些流程不需要依该法规第61（1）条进行批准。依法规（EU）536/2014第63（2）条规定，临床试验药品的优良生产规范不适用于这些流程。
(4) For the manufacturer to be able to complywith good manufacturing practice for investigational medicinal products,cooperation between the manufacturer and the sponsor is necessary. Likewi,for the sponsor to comply with the requirements of Regulation (EU) No 536/2014cooperation with the manufacturer is necessary. Where the manufacturer and thesponsor are different legal entities, the obligations of the manufacturer andsponsor vis-à-vis each other should be specified in a technical agreementbetween them. Such an agreement should provide for the sharing of inspectionreports and exchange of information on quality issues.
对于可以符合临床试验药品的生产商，有必要与申办方合作。类似的，对于符合法规（EU）
536/2014规定的申办人，有必要与生产商进行合作。如果生产商和申办人为不同法律主体，则生产商和申办人的义务应在其双方签订的一份技术协议中做出相应规定。此协议应包括检查报告共享和质量问题信息互换。
英语自我介绍结尾(5) Investigational medicinal products importedinto the Union should be manufactured by applying quality standards at leastequivalent to tho in the Union. For this reason, only products manufacturedby a third country manufacturer that is entitled or authorid to do so inaccordance with the laws of the country where the manufacturer is located,should be allowed to be imported into the Union.
进口至欧盟的临床试验药品应依至少等同于欧盟的质量标准进行生产。鉴于此，只有第三国生产商生产的药品依其所在国法律获得批准或授权进行此类药品生产时才允许进口至欧盟。
最美公主(6) All manufacturers should operate an effectivequality assurance system of their manufacturing or import operations. Such asystem in order to be effective requires the implementation of a pharmaceuticalquality system. Good documentation constitutes an e
sntial part of a qualityassurance system. The documentation system of manufacturers shall enable thehistory of the manufacture of each batch and any changes introduced during thedevelopment of an investigational medicinal product to be traced.
