【奥译言】英国计划脱欧后放宽对低风险临床试验的规定

2019-10-23 11:04 阅读数：3005 标签：

英国政府提议脱欧后放宽对最低风险临床试验的监管要求。官员们在一系列改革方案中提出了这一建议，旨在使英国脱欧后处于生命科学领域的优秀地位。

《药品和医疗器械法案》的完整内容尚未公布，但政府上周在一份简报文件中概述了其主要益处和要点。该计划的首要目标是让英国走在生命科学行业的前沿，从而缩短患者用上所需药品的时间，并让其在治愈罕见疾病方面发挥主导作用。

为了实现这些目标，政府计划“消除最低风险临床试验中不必要的官僚作风，鼓励高效迅速地引进新药。”即将出台的欧盟临床试验规则因对小型、低风险研究造成过重负担而在某些方面受到批评。放宽规定的计划是英国针对医院简化创新药物和诊断器械制造和试验过程的其中一项内容。

政府还希望利用该法案来推动英国药品和健康产品管理局（MHRA）制定相关法规的进程，帮助企业“在复杂的临床试验中开拓新天地”。

简报文件中还提到了其他计划，包括计划实施一项阻止假药进入供应链的方案、计划登记网上零售商以及计划建立一个可以为立法更新提供支持的框架。政府希望能够更新生命科学各个方面的立法，以应对患者安全问题以及英国的未来全球关系变化。

政府介绍了计划出台的《药品和医疗器械法案》的详细信息，用于为即将举行的议会制定立法议程。此次女王演讲的发生背景不同寻常，因为是否会就该法案的任何内容进行辩论并予以通过都是一个未知之谜。

照目前情况来看，支持政府通过该立法的只占少数，这意味着政府需要依靠反对党的支持才能将《药品和医疗器械法案》纳入法律。由于观察人士预计今年或明年将举行大选，本届议会通过该立法的可能性进一步降低。如果现政府赢得选举，则可能将《药品和医疗器械法案》纳入下届议会的立法议程。

英文原文

UK Plans to Loosen Rules on Low-Risk Clinical Trials in Post-Brexit Shakeup

The United Kingdom government has proposed relaxing the regulatory requirements on the lowest risk clinical trials after it leaves the European Union. Officials made the proposal in a suite of changes intended to make the UK a leading location for life sciences companies after Brexit.

Full details of the Medicines and Medical Devices Bill are yet to emerge, but the government sketched out the main benefits and elements in a briefing document this week. The overarching goals of the plan are to put the UK at the forefront of the life sciences industry, thereby cutting the time it takes for patients to access medicines and to give it a leading role in efforts to cure rare diseases.

To achieve those goals, the government plans to “remove unnecessary bureaucracy for the lowest risk clinical trials, encouraging the rapid introduction of new medicines.” The outgoing EU clinical trial rules were criticized in some quarters for imposing excessive burdens on small, low-risk studies. The planned loosening of the UK rules is part of a push to make it easier for hospitals to trial and make medicines and diagnostics devices.

The government also wants to use the legislation to drive the Medicines and Healthcare products Regulatory Agency (MHRA) to develop regulations to help companies “break new ground in complex clinical trials.”

Other plans discussed in the briefing document include the implementation of a scheme to stop fake drugs from entering the supply chain, plans to register online retailers and the creation of a framework that supports the updating of legislation. The government wants the ability to update legislation on all aspects of life sciences in response to patient safety issues and changes to the UK’s future global relationships.

The government presented details of the planned bill as part of the Queen’s Speech, which is used to set out the legislative agenda for the upcoming parliament. On this occasion, the Queen’s Speech took place in an unusual context that means it is questionable whether any of the proposed texts will be debated and passed.

来源：RAPS

原文链接：https://www.raps.org/news-and-articles/news-articles/2019/10/eu-regulatory-roundup-uk-plans-to-loosen-rules-on

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