<p>（第一财经）4 月 27 日——中国主要药品监管机构发布新规，要求获得有条件上市批准的创新药物在四年内完成确认性临床研究，否则将面临被撤回市场的风险。</p>
<p>国家药品监督管理局的新政策自 4 月 24 日起生效，这意味着药品制造商必须在获得有条件批准后的四年内完成所需研究，以获得正式批准。未能按时完成的企业原则上只能申请一次延期，而药品注册证书的有效期将不会随研究截止日期的延长而延长。</p>
<p>根据新规，如果研究未在截止日期前完成且未获得延期，或者在延期后仍未完成，药品的注册证书将被撤销或其批准适应症将被减少。</p>
<p>该政策为药品上市许可持有人快速完成确认性研究创造了制度激励和约束，特别是因为药品注册证书的有效期不会延长，一位从事药品临床研究和开发的人士告诉第一财经。</p>
<p>该新规还将堵住一个政策漏洞，以前允许有条件批准的药物在疗效尚未完全验证的阶段长期存在，该人士指出。</p>
<p><strong>打击 “搭便车” 创新</strong></p>
<p>此外，同质化的 “搭便车” 创新将受到遏制。根据新规，如果具有相同机制、靶点和适应症的药物已经获得正式上市批准，类似药物的有条件批准通道将被关闭。</p>
<p>新规 “严格控制有条件批准的审查标准，防止搭便车行为，” 一位接近国家药品监督管理局药品评价中心的专家告诉第一财经。</p>
<p><strong>背景：以往规则的缺口</strong></p>
<p>2020 年修订的《药品注册管理办法》首次正式建立了中国的有条件批准程序。该系统允许在临床急需的情况下，基于早期临床试验数据批准创新药物和改进的新药，显著缩短了上市前的审查和试验周期，帮助更快满足患者的医疗需求。</p>
<p>该措施规定，获得有条件批准的药物必须随后完成确认性研究。但由于未对此类研究设定时间限制，一些药品制造商在产品进入市场后缺乏紧迫感。</p>
<p>自中国首个有条件批准的新药于 2020 年获批以来，约有 140 种药物涵盖近 200 个适应症通过这一途径进入市场。只有约 30 个适应症完成了确认性研究并获得正式批准，而大多数药物或适应症在上市后长期处于有条件批准状态。</p>
<p>编辑：唐诗华，艾米·莱恩</p>

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<p>中国国家药品监督管理局实施了新规，要求获得有条件上市批准的创新药物在四年内完成确认性临床研究。未能按时完成可能导致药物被撤回市场。该政策旨在加快审批流程，并弥补允许药物长期保持有条件批准的漏洞。此外，新规将通过关闭与已批准药物相似的药物的有条件批准渠道，防止 “搭便车” 式的创新</p>

<p>(Yicai) April 27 -- China’s main drug regulator has issued new rules requiring innovative drugs granted conditional marketing approval to complete confirmatory clinical studies within four years or risk being withdrawn from the market.</p>
<div class="lb-trans"><p>（第一财经）4 月 27 日——中国主要药品监管机构发布新规，要求获得有条件上市批准的创新药物在四年内完成确认性临床研究，否则将面临被撤回市场的风险。</p>
</div><p>The National Medical Products Administration's new policy, which took effect on April 24, means drugmakers must complete the required studies within four years of conditional approval to obtain regular approval. Those who fail to do so may, in principle, apply for only one extension, while the validity period of the drug registration certificate will not be extended along with the study deadline.</p>
<div class="lb-trans"><p>国家药品监督管理局的新政策自 4 月 24 日起生效，这意味着药品制造商必须在获得有条件批准后的四年内完成所需研究，以获得正式批准。未能按时完成的企业原则上只能申请一次延期，而药品注册证书的有效期将不会随研究截止日期的延长而延长。</p>
</div><p>If the studies are not completed by the deadline and no extension is granted, or if they remain unfinished after an extension, the drug’s registration certificate will be revoked or its approved indications reduced, according to the new rules.</p>
<div class="lb-trans"><p>根据新规，如果研究未在截止日期前完成且未获得延期，或者在延期后仍未完成，药品的注册证书将被撤销或其批准适应症将被减少。</p>
</div><p>The policy creates institutional incentives and constraints for drug marketing authorization holders to complete confirmatory studies quickly, especially because the validity period of the drug registration certificate will not be extended, a person engaged in drug clinical research and development told Yicai.</p>
<div class="lb-trans"><p>该政策为药品上市许可持有人快速完成确认性研究创造了制度激励和约束，特别是因为药品注册证书的有效期不会延长，一位从事药品临床研究和开发的人士告诉第一财经。</p>
</div><p>The new rules will also close a policy loophole that has allowed conditionally approved drugs to remain for long periods in a stage where their efficacy has not been fully verified, the person noted.</p>
<div class="lb-trans"><p>该新规还将堵住一个政策漏洞，以前允许有条件批准的药物在疗效尚未完全验证的阶段长期存在，该人士指出。</p>
</div><p><strong>Crackdown on “Piggybacking&#34; Innovation</strong></p>
<div class="lb-trans"><p><strong>打击 “搭便车” 创新</strong></p>
</div><p>In addition, homogenized “piggybacking&#34; innovation will be curbed. Under the new rules, if a drug with the same mechanism, target, and indication has already obtained regular marketing approval, the conditional approval channel for similar drugs under development or review will be closed.</p>
<div class="lb-trans"><p>此外，同质化的 “搭便车” 创新将受到遏制。根据新规，如果具有相同机制、靶点和适应症的药物已经获得正式上市批准，类似药物的有条件批准通道将被关闭。</p>
</div><p>The new rules “strictly control the review standards for conditional approval and prevent piggybacking behaviors,” an expert close to the Center for Drug Evaluation of the NMPA told Yicai.</p>
<div class="lb-trans"><p>新规 “严格控制有条件批准的审查标准，防止搭便车行为，” 一位接近国家药品监督管理局药品评价中心的专家告诉第一财经。</p>
</div><p><strong>Background: Gaps in Previous Rules</strong></p>
<div class="lb-trans"><p><strong>背景：以往规则的缺口</strong></p>
</div><p>The Measures for the Administration of Drug Registration, revised in 2020, formally established China’s conditional approval procedure for the first time. The system allows innovative drugs and improved new drugs in urgent clinical need to be approved based on early clinical trial data, significantly shortening the pre-market review and trial period and helping meet patients’ medical needs sooner.</p>
<div class="lb-trans"><p>2020 年修订的《药品注册管理办法》首次正式建立了中国的有条件批准程序。该系统允许在临床急需的情况下，基于早期临床试验数据批准创新药物和改进的新药，显著缩短了上市前的审查和试验周期，帮助更快满足患者的医疗需求。</p>
</div><p>The measures state that conditionally approved drugs must later complete confirmatory studies. But because no time limit had been set for such studies, some drugmakers lacked urgency after their products entered the market.</p>
<div class="lb-trans"><p>该措施规定，获得有条件批准的药物必须随后完成确认性研究。但由于未对此类研究设定时间限制，一些药品制造商在产品进入市场后缺乏紧迫感。</p>
</div><p>Since China’s first conditionally approved new drug was cleared in 2020, about 140 drugs covering nearly 200 indications have entered the market through this pathway. Only about 30 indications have completed confirmatory studies and obtained regular approval, while most drugs or indications have remained under conditional approval for a long time after launch.</p>
<div class="lb-trans"><p>自中国首个有条件批准的新药于 2020 年获批以来，约有 140 种药物涵盖近 200 个适应症通过这一途径进入市场。只有约 30 个适应症完成了确认性研究并获得正式批准，而大多数药物或适应症在上市后长期处于有条件批准状态。</p>
</div><p>Editors: Tang Shihua, Emmi Laine</p>
<div class="lb-trans"><p>编辑：唐诗华，艾米·莱恩</p>
</div>

中国给予有条件批准的新药四年时间来完成试验