<p><img src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2026/03/shutterstock_2162887311-1-430x241.jpg?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2026/03/shutterstock_2162887311-1-430x241.jpg"/></p>
<p>MHRA 首席执行官 Lawrence Tallon 表示，此举将使创新药物提前最多六个月进入市场。图片来源：Ink Drop/Shutterstock.com。</p>
<p>药品和医疗产品监管局（MHRA）与国家卫生与护理卓越研究所（NICE）将同时对新药做出各自的决定，这是对该国药物监管的全面改革的一部分。</p>
<p>正在建立一个协调的路径，NICE 将提前做出对 NHS 推荐的决定，与 MHRA 的许可裁决同步。希望这一新框架将在 4 月 1 日启动，使药物能够提前三到六个月到达患者，并为公司提供更好的商业规划平台。</p>
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<p>目前，MHRA 发布市场授权与 NICE 发布成本效益指导之间存在 90 天的间隔。NICE 的单一技术评估（STA）过程通常需要约 38 周。</p>
<p>MHRA 首席执行官 Lawrence Tallon 表示：“与 NICE 的合作发展是关于健康和繁荣。精简的监管系统对患者更有利，因为这意味着创新药物可以提前最多六个月进入市场。”</p>
<p>2025 年 10 月，这两个卫生机构启动了新计划的试点，邀请制药公司注册为早期采用者。共有 27 家公司报名，首批治疗方案目前正在通过协调路径进行。预计首个指导将在 2026 年 6 月发布。</p>
<p>在这一路径的同时，NICE 和 MHRA 还推出了改进的综合科学建议服务，通过单一渠道传达市场授权和健康技术评估的证据要求。这可以帮助制药公司提前规划临床开发，例如使用特定的终点。</p>
<p>NICE 首席执行官 Jonathan Benger 教授评论新规定时表示：“这些将为公司提供可预测的时间表，以支持有效规划，提前告知他们所需的证据，并帮助消除不必要的延误。”</p>
<p>欧洲制药工业和协会联合会（EFPIA）2025 年的一份报告显示，英格兰在 2020-2023 年新药可用性排名中位列第六。</p>
<p>英国政府已认识到该国生命科学部门未能发挥其全部潜力。在其 生命科学部门计划 中，部长们概述了简化监管和增强市场准入的计划，这是六项优先战略之一。MHRA 与 NICE 之间的协调是改革过程中采取的首个重大步骤之一。</p>
<p>六点行动计划旨在确保英国生命科学部门在 2035 年前实现 410 亿英镑的预期价值增长，增长幅度达到 165%。政府的目标是使英国成为欧洲领先的生命科学经济体，并成为仅次于美国和中国的全球第三大生命科学经济体。</p>
<p>健康与安全创新部长 Zubir Ahmed 博士表示：“我们正在减少繁文缛节，以便安全有效的新药能够更快地到达 NHS 患者。不仅如此，这还将为公司提供更清晰、更快速的决策，帮助使英国成为一个更具吸引力的生命科学投资地，并推动创新上市，从而促进经济发展。”</p>

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<p>MHRA（英国药品和健康产品监管局）和 NICE（国家卫生与临床优化研究所）推出了一条协调路径，以简化英国的药品监管，允许创新药物提前最多六个月获得准入。该举措旨在缩短目前市场授权与成本效益指导之间的 90 天差距。新的框架将于 2026 年 4 月 1 日起生效，将增强制药公司的规划能力，并且是英国政府推动生命科学行业战略的一部分，目标是到 2035 年实现 410 亿英镑的增长</p>

<p><img src="https://imageproxy.pbkrs.com/https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2026/03/shutterstock_2162887311-1-430x241.jpg" alt="" original-src="https://www.pharmaceutical-technology.com/wp-content/uploads/sites/24/2026/03/shutterstock_2162887311-1-430x241.jpg"/></p>
<p>MHRA chief Lawrence Tallon said the move will allow earlier access to innovative medicines by up to six months. Credit: Ink Drop/Shutterstock.com.</p>
<div class="lb-trans"><p>MHRA 首席执行官 Lawrence Tallon 表示，此举将使创新药物提前最多六个月进入市场。图片来源：Ink Drop/Shutterstock.com。</p>
</div><p>The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) will make their respective decisions on new drugs at the same time as part of an overhaul to medicine regulation in the country.</p>
<div class="lb-trans"><p>药品和医疗产品监管局（MHRA）与国家卫生与护理卓越研究所（NICE）将同时对新药做出各自的决定，这是对该国药物监管的全面改革的一部分。</p>
</div><p>An aligned pathway is being established that will see NICE bring forward its decision for NHS recommendations alongside the MHRA’s licensing verdict. The hope is that the new framework, which launches on 1 April, will bring medicines to patients three to six months sooner and provide companies with a better platform for commercial planning.</p>
<div class="lb-trans"><p>正在建立一个协调的路径，NICE 将提前做出对 NHS 推荐的决定，与 MHRA 的许可裁决同步。希望这一新框架将在 4 月 1 日启动，使药物能够提前三到六个月到达患者，并为公司提供更好的商业规划平台。</p>
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<div class="lb-trans"><h3>深入了解 GlobalData</h3>
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</div><p>Currently, there’s a 90-day gap between MHRA issuing a marketing authorisation and NICE publishing its guidance on cost-effectiveness. Single Technology Appraisals (STA), NICE’s process for evaluating a new treatment, generally takes around 38 weeks.</p>
<div class="lb-trans"><p>目前，MHRA 发布市场授权与 NICE 发布成本效益指导之间存在 90 天的间隔。NICE 的单一技术评估（STA）过程通常需要约 38 周。</p>
</div><p>Lawrence Tallon, MHRA’s CEO, said: “This development with our partners at NICE is about health and prosperity. A streamlined regulatory system is better for patients as it means earlier access to innovative medicines by up to six months.”</p>
<div class="lb-trans"><p>MHRA 首席执行官 Lawrence Tallon 表示：“与 NICE 的合作发展是关于健康和繁荣。精简的监管系统对患者更有利，因为这意味着创新药物可以提前最多六个月进入市场。”</p>
</div><p>In October 2025, the two health agencies initiated a pilot of the new scheme, inviting pharmaceutical companies to register as early adopters. A total of 27 companies signed up, and the first treatments are currently going through the aligned pathway. The first guidance is expected in June 2026.</p>
<div class="lb-trans"><p>2025 年 10 月，这两个卫生机构启动了新计划的试点，邀请制药公司注册为早期采用者。共有 27 家公司报名，首批治疗方案目前正在通过协调路径进行。预计首个指导将在 2026 年 6 月发布。</p>
</div><p>Alongside the pathway, NICE and the MHRA are also launching an improved Integrated Scientific Advice service, in which evidence requirements for market authorisation and health technology assessment are relayed through a single channel. This can help pharma companies with early planning of clinical development, such as the use of specific endpoints.</p>
<div class="lb-trans"><p>在这一路径的同时，NICE 和 MHRA 还推出了改进的综合科学建议服务，通过单一渠道传达市场授权和健康技术评估的证据要求。这可以帮助制药公司提前规划临床开发，例如使用特定的终点。</p>
</div><p>Commenting on the new provisions, Professor Jonathan Benger, chief executive of NICE, said: “They will give companies predictable timelines to support effective planning, tell them what evidence is required earlier in the process and help to remove unnecessary delays.”</p>
<div class="lb-trans"><p>NICE 首席执行官 Jonathan Benger 教授评论新规定时表示：“这些将为公司提供可预测的时间表，以支持有效规划，提前告知他们所需的证据，并帮助消除不必要的延误。”</p>
</div><p>A 2025 report from the European Federation of Pharmaceutical Industries and Associations (EFPIA) revealed that England lay sixth when ranked for the availability of new medicines licensed in 2020-2023.</p>
<div class="lb-trans"><p>欧洲制药工业和协会联合会（EFPIA）2025 年的一份报告显示，英格兰在 2020-2023 年新药可用性排名中位列第六。</p>
</div><p>The UK Government has recognised that the country’s life sciences sector is not reaching its full potential. In its Life Sciences sector plan, ministers outlined plans for streamlining regulation and enhancing market access, one of six priority strategies. The alignment between the MHRA and NICE is one of the first major steps taken as part of the revamp.</p>
<div class="lb-trans"><p>英国政府已认识到该国生命科学部门未能发挥其全部潜力。在其 生命科学部门计划 中，部长们概述了简化监管和增强市场准入的计划，这是六项优先战略之一。MHRA 与 NICE 之间的协调是改革过程中采取的首个重大步骤之一。</p>
</div><p>The six-point action plan is to ensure the UK life sciences sector reaches its forecasted value increase of £41bn, representing a growth of 165% by 2035. The government is aiming to make the UK the leading life sciences economy in Europe, and the third largest in the world behind only America and China.</p>
<div class="lb-trans"><p>六点行动计划旨在确保英国生命科学部门在 2035 年前实现 410 亿英镑的预期价值增长，增长幅度达到 165%。政府的目标是使英国成为欧洲领先的生命科学经济体，并成为仅次于美国和中国的全球第三大生命科学经济体。</p>
</div><p>Dr Zubir Ahmed, minister for health and safety innovation, said: “We’re cutting red tape so safe and effective new medicines can reach NHS patients sooner. Not only that, but this will also give companies clearer, quicker decisions – helping make the UK an even more attractive place to invest in life sciences and bring innovations to market, boosting the economy in the process.”</p>
<div class="lb-trans"><p>健康与安全创新部长 Zubir Ahmed 博士表示：“我们正在减少繁文缛节，以便安全有效的新药能够更快地到达 NHS 患者。不仅如此，这还将为公司提供更清晰、更快速的决策，帮助使英国成为一个更具吸引力的生命科学投资地，并推动创新上市，从而促进经济发展。”</p>
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MHRA 和 NICE 推出了一个加速药品监管的协调路径