醫(yī)械創(chuàng)新資訊
英國(guó)政府提議脫歐后放寬對(duì)最低風(fēng)險(xiǎn)臨床試驗(yàn)的監(jiān)管要求。官員們?cè)谝幌盗懈母锓桨钢刑岢隽诉@一建議，旨在使英國(guó)脫歐后處于生命科學(xué)領(lǐng)域的領(lǐng)先地位。
《藥品和醫(yī)療器械法案》的完整內(nèi)容尚未公布，但政府上周在一份簡(jiǎn)報(bào)文件中概述了其主要益處和要點(diǎn)。該計(jì)劃的首要目標(biāo)是讓英國(guó)走在生命科學(xué)行業(yè)的前沿，從而縮短患者用上所需藥品的時(shí)間，并讓其在治愈罕見疾病方面發(fā)揮主導(dǎo)作用。
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為了實(shí)現(xiàn)這些目標(biāo)，政府計(jì)劃“消除最低風(fēng)險(xiǎn)臨床試驗(yàn)中不必要的官僚作風(fēng)，鼓勵(lì)高效迅速地引進(jìn)新藥。”即將出臺(tái)的歐盟臨床試驗(yàn)規(guī)則因?qū)π⌒汀⒌惋L(fēng)險(xiǎn)研究造成過重負(fù)擔(dān)而在某些方面受到批評(píng)。放寬規(guī)定的計(jì)劃是英國(guó)針對(duì)醫(yī)院簡(jiǎn)化創(chuàng)新藥物和診斷器械制造和試驗(yàn)過程的其中一項(xiàng)內(nèi)容。
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政府還希望利用該法案來推動(dòng)英國(guó)藥品和健康產(chǎn)品管理局（MHRA）制定相關(guān)法規(guī)的進(jìn)程，幫助企業(yè)“在復(fù)雜的臨床試驗(yàn)中開拓新天地”。
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簡(jiǎn)報(bào)文件中還提到了其他計(jì)劃，包括計(jì)劃實(shí)施一項(xiàng)阻止假藥進(jìn)入供應(yīng)鏈的方案、計(jì)劃登記網(wǎng)上零售商以及計(jì)劃建立一個(gè)可以為立法更新提供支持的框架。政府希望能夠更新生命科學(xué)各個(gè)方面的立法，以應(yīng)對(duì)患者安全問題以及英國(guó)的未來全球關(guān)系變化。
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政府介紹了計(jì)劃出臺(tái)的《藥品和醫(yī)療器械法案》的詳細(xì)信息，用于為即將舉行的議會(huì)制定立法議程。此次女王演講的發(fā)生背景不同尋常，因?yàn)槭欠駮?huì)就該法案的任何內(nèi)容進(jìn)行辯論并予以通過都是一個(gè)未知之謎。
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照目前情況來看，支持政府通過該立法的只占少數(shù)，這意味著政府需要依靠反對(duì)黨的支持才能將《藥品和醫(yī)療器械法案》納入法律。由于觀察人士預(yù)計(jì)今年或明年將舉行大選，本屆議會(huì)通過該立法的可能性進(jìn)一步降低。如果現(xiàn)政府贏得選舉，則可能將《藥品和醫(yī)療器械法案》納入下屆議會(huì)的立法議程。
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.
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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.
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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.
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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.”
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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.
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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.
