新闻翻译-FDA海外临床试验新法规

1、http:/product- nical-trials-fda-vs-industry/ A U.S.Food and Drug Administration proposal entitled“Human Subject Protection: Acceptance of Data From Clinical Studies for Medical Devices”is inciting the medical device industrys top trade group,along with several major manufacturers. If enacted,the pro

2、posed rule would require that clinical studies involving medical devices conducted outside the United States“be conducted in accordance with good clinical practice(GCP,which includes obtaining and documenting the review and approval of the study by an independent ethics committee(IECand obtaining an

3、d documenting freely given informed consent of study subjects.”美国食品和药品监督管理局建议,题为“人类主题保护:接受”医疗器械临床研究的数据来源是煽动医疗器械行业的贸易集团,随着几大厂商。如果获得通过,拟议的规则将要求在美国以外进行的涉及医疗器械的临床研究“进行良好的临床管理规范(GCP,其中包括获得和记录由一个独立的伦理委员会的审查和批准本研究根据(IEC和自由获取和记录受试者的知情同意。“Various players in the medical device industry have taken issue with t

4、he FDAs actions,outlining their grievances in written comments to the rule.First,the industry has taken issue with some of the documents cited in the proposed rule, arguing that they have no application to medical devices.In its“Reasons for Proposing to Revise the Regulations,”the FDA references the

5、 International Conference on Harmonisation(ICHof Technical Requirements for Registration of Pharmaceuticals for Human Uses document entitled“Good Clinical Practice: Consolidated Guideline”as one of”several notable documents”that identifies “ethical and other principles that provide assurance of the

6、quality and integrity of clinical data and adequate protection of human subjects.”The ICHs guideline defines good clinical practice(GCPas“a standard for the design,conduct, performance,monitoring,auditing,recording,analyses,and reporting of clinical trials that provides assurance that the data and r

7、eported results are credible and accurate,and that the rights,integrity,and confidentiality of trial subjects are protected.”According to the Advanced Medical Technology Association(“AdvaMed” and the medical device companies who commented on the rule,the ICH guidelines do not provide any guidance fo

8、r medical devices,and thus should not be used as support for the rule.厂商在医疗器械行业已采取各种问题与FDA的行动规则的书面意见中,概述了他们的不满。首先,该行业已采取一些拟议的规则中引用的文件的问题,争辩说,他们没有医疗设备的应用程序。在其“理由,提议修订”条例“,”FDA引用的人类使用的文档药品注册技术要求国际协调会议(ICH题为“良好的临床实践:综合指引”为一体的“几个显着的文档“标识”提供保证的质量和诚信的临床数据和充分保护人类受试者的道德和其他原则。“ICH的指导方针定义为”标准的设计,行为,性能良好的临床实践(

9、GCP,监控,稽查,记录,分析和报告临床试验的数据和报告的结果是可信的,准确的,并提供保证受试者的权利,完整性和保密性得到保障。“根据先进医疗技术协会(先进医疗技术协会“和医疗设备公司评论规则,ICH指导原则不提供任何指导的医疗设备,因此不应该被用来作为规则的支持。Second,AdvaMed expressed its concern that the non-U.S.regulatory and clinical community could present serious barriers to the FDA rule,making it difficult or impossibl

10、e for medical device companies to conduct business in that environment. In other words,not all foreign nations would permit disclosure of the very information that is needed to make the assurances required by the FDA rule.二,先进医疗技术协会表示关注非美的法规和临床社群可能会和FDA的规则之间出现严重的障碍,将会使得医疗设备公司开展业务更加的困难。换句话说,并不是所有的外国国

11、家允许揭露FDA需要的讯息披露。Boston Scientific Corp.echoed AdvaMeds concerns,pointing out that the proposed regulation sets out requirements for clinical studies conducted outside the U.S., without any corresponding explicit support from foreign regulators.Many of the medical device companies,including Indiana-b

12、ased Cook Group Inc.,argued that the data required by the FDA to demonstrate compliance will be unable to be supplied, based on the standards of good clinical practice or the laws of different countries or regions.In its comment to the rule,Cook argued that the FDA“has no statutory authority to regu

13、late the conduct of studies conducted outside the United States.”波士顿科学公司赞同先进医疗技术协会的关注(即上述的规定,指出在拟议规例在美国境外进行的临床研究中,没有任何外国监管机构相应的明确的支持要求。很多的医疗器械公司,包括印第安纳州的库克集团股份有限公司,争辩,以证明符合FDA要求的数据将无法提供,基于良好的临床实践的标准或不同国家或地区的法律。在其注释的规则,库克认为,美国FDA“没有法定权力,规范的行为在美国以外进行的研究。”Lastly,device companies complained that the FDA

14、s requirement that they vet an ethics committee abroad goes beyond whats expected of them domestically.Johnson &Johnson also noted that foreign committees may not wish or be able to provide thenecessary information required for the vetting process,such as qualifications of the ethics committee m

15、embers.最后,设备公司抱怨说,FDA的要求,他们的兽医国外伦理委员会超越他们的预期。强生(Johnson&Johnson也指出,外国委员会未必愿意或能够提供审批过程中所需的必要信息,如伦理委员会成员的资格。AdvaMed recommends that,in order to avoid these pitfalls,the FDA should broker agreements with other countries in advance in order to authorize the proposed framework for clinical trials.By

16、convening a group of international regulators and industry officials,AdvaMed says,the FDA could”fast track”harmonized guidelines that all relevant players agree upon.This way,according to the trade group, sovereign nations outside the U.S.would not view the FDA as unilaterally imposing its own stand

17、ards on international device regulators.先进医疗技术协会建议,为了避免这些缺陷,使用本品时应与其他国家提前经纪协议授权的拟议框架进行临床试验。通过召集一个国际监管机构和行业官员,先进医疗技术协会说,FDA可以“快速跟踪”所有相关的参与者商定的统一准则。通过这种方式,根据该贸易团体,在美国以外的主权国家不会查看FDA单方面制定自己的标准,国际设备监管。For its part,the FDA explains in its proposed rule that it is aiming to streamline oversight by bringing

18、 all types of device approval applications under one common standard for conducting clinical trials outside the U.S.As of now,clinical trials supporting premarket approval applications for potentially risky devices must be conducted in accordance with the laws of the country where theyre conducted,o

19、r with the Declaration of Helsinki(a set of international ethical principles established in1964.This means that studies involving multiple countries can face a mix of standards,creating uncertainty and delays.Thus,the FDA says,the aim of the proposed rule is to actually decrease the regulatory burde

20、n for device makers, while providing greater protection of patients participating in clinical trials.对于它的一部分,FDA在其拟议的规则解释,它的目标是简化监督,使一个共同的标准下,所有类型的设备核准申请进行临床试验,截至目前,临床试验在美国以外的支持潜在风险的上市前批准申请设备必须按照他们进行所在国的法律,或与赫尔辛基宣言“(成立于1964年的国际伦理原则进行。这意味着,涉及多个国家的研究可以面对标准的混合,创造的不确定性和拖延。因此,FDA表示,拟议的规则的目的,实际上是降低设备制造商的监管负担,同时参加临床试验的患者提供更大的保护。Given how many medical device companies rely on clinical trials conducted abroad, the final version of this rule will have a significant impact on the medical device industry.Depending on the requirements outlined in the final rule,device companies may cho