<p>（第一财经）5 月 8 日——中国将给予符合条件的创新儿科药物制造商最长两年的市场独占期，以鼓励儿科药物的研发并支持创新。</p>
<p>除了市场独占期，国家卫生健康委员会和其他七个中国部委昨日发布的新政策还引入了符合特定要求的儿科药物的专利期限补偿。</p>
<p>该政策是中国 2014 年发布的首个全面确保儿科药物可用性的政策文件的首次更新，将重点支持针对常见儿童疾病的创新药物研发、组合疫苗、适合儿科药物的配方以及儿童罕见疾病的治疗。</p>
<p>对于指定的创新儿科治疗，监管机构将通过早期干预、协调审查流程和滚动提交，帮助开发者持续提高药物开发的效率。</p>
<p>政府将鼓励研究新的工具、方法和儿科药物监管标准，并探索建立国家儿科临床试验协作网络和跨机构伦理审查机制的可能性，以应对儿科药物开发效率低和招募参与者等挑战。</p>
<p>监管机构还承诺支持在多中心协作模式下增强真实世界证据和前瞻性研究设计，以及将现有药物安全数据从成人群体推断到中国的儿科人群。</p>
<p>此外，监管机构将优先审查和批准纳入鼓励创新儿科药物和仿制药名单的药物注册申请，并加快其纳入国家基本药物目录的进程。</p>
<p>国家卫生健康委员会将与国家药品监督管理局共同制定医疗机构常用儿科配方药物的清单，针对临床必要但市场上缺乏或没有儿科特定配方和剂量的药物。同时，将主导制定儿科药物的临床应用指南，并探索制定儿童国家基本药物目录。</p>
<p>监管机构将支持为儿童开发覆盖创新药物和罕见疾病药物的商业保险产品。在药物集中采购期间，将实施激励政策以支持适合儿童的配方和规格的供应。</p>
<p>编辑：唐诗华，Futura Costaglione</p>

纳斯达克中国金龙指数

中国龙 ETF - Roundhill

中概股 ETF - PowerShares

中国 MSCI ETF - iShares

<p>中国将向符合条件的创新儿科药物制造商提供最长两年的市场独占权，以促进儿科药物的研发。国家卫生健康委员会及其他部门发布的新政策还引入了专利期限补偿，旨在支持常见儿童疾病和罕见疾病的治疗发展。监管机构将协助提高药物开发效率，并优先处理创新儿科药物的注册申请。此外，政府将探索国家儿科临床试验网络，并支持儿童商业保险产品的开发</p>

<p>(Yicai) May 8 -- China will grant manufacturers of eligible innovative pediatric drugs a market exclusivity period of up to two years to encourage the research and development of pediatric medicines and support innovation.</p>
<div class="lb-trans"><p>（第一财经）5 月 8 日——中国将给予符合条件的创新儿科药物制造商最长两年的市场独占期，以鼓励儿科药物的研发并支持创新。</p>
</div><p>In addition to market exclusivity, the new policy issued yesterday by the National Health Commission and seven other Chinese ministries also introduces patent term compensations for pediatric drugs that meet certain requirements.</p>
<div class="lb-trans"><p>除了市场独占期，国家卫生健康委员会和其他七个中国部委昨日发布的新政策还引入了符合特定要求的儿科药物的专利期限补偿。</p>
</div><p>This policy, which is the first update to China’s first comprehensive policy document to ensure the availability of pediatric drugs released in 2014, will focus on supporting the R&amp;D of innovative drugs for common childhood diseases, combination vaccines, suitable formulations for pediatric medications, and treatments for rare diseases in children.</p>
<div class="lb-trans"><p>该政策是中国 2014 年发布的首个全面确保儿科药物可用性的政策文件的首次更新，将重点支持针对常见儿童疾病的创新药物研发、组合疫苗、适合儿科药物的配方以及儿童罕见疾病的治疗。</p>
</div><p>For designated innovative pediatric treatments, regulators will assist developers in continuously improving the efficiency of drug development through early intervention, coordinated review processes, and rolling submissions.</p>
<div class="lb-trans"><p>对于指定的创新儿科治疗，监管机构将通过早期干预、协调审查流程和滚动提交，帮助开发者持续提高药物开发的效率。</p>
</div><p>The government will encourage the research of new tools, methods, and standards for pediatric drug regulation and explore the possibility of setting up a national pediatric clinical trial collaboration network and a cross-institutional ethical review mechanism to address challenges, such as low efficiency in pediatric drug development and recruiting participants.</p>
<div class="lb-trans"><p>政府将鼓励研究新的工具、方法和儿科药物监管标准，并探索建立国家儿科临床试验协作网络和跨机构伦理审查机制的可能性，以应对儿科药物开发效率低和招募参与者等挑战。</p>
</div><p>The regulators also pledged to support the enhancement of real-world evidence and prospective research design within a multi-center collaboration model, as well as the extrapolation of existing drug safety data from the adult to the pediatric population in China.</p>
<div class="lb-trans"><p>监管机构还承诺支持在多中心协作模式下增强真实世界证据和前瞻性研究设计，以及将现有药物安全数据从成人群体推断到中国的儿科人群。</p>
</div><p>Moreover, the regulators will give review and approval priority to the registration applications for drugs included in the list of encouraged innovative pediatric drugs and generic medicines, as well as accelerate their inclusion in the National Essential Medicines List.</p>
<div class="lb-trans"><p>此外，监管机构将优先审查和批准纳入鼓励创新儿科药物和仿制药名单的药物注册申请，并加快其纳入国家基本药物目录的进程。</p>
</div><p>The NHC, together with the National Medical Products Administration, will develop a list of commonly used pediatric formulations by medical institutions for drugs that are clinically necessary but unavailable on the market or without pediatric-specific formulations and dosages. It will also take the lead in formulating clinical application guidelines for pediatric medications and exploring the development of a National Essential Medicines List for children.</p>
<div class="lb-trans"><p>国家卫生健康委员会将与国家药品监督管理局共同制定医疗机构常用儿科配方药物的清单，针对临床必要但市场上缺乏或没有儿科特定配方和剂量的药物。同时，将主导制定儿科药物的临床应用指南，并探索制定儿童国家基本药物目录。</p>
</div><p>The regulators will support the development of commercial insurance products for children covering innovative drugs and medications for rare diseases. During the centralized procurement of drugs, incentive policies will be implemented to support the supply of formulations and specifications suitable for children.</p>
<div class="lb-trans"><p>监管机构将支持为儿童开发覆盖创新药物和罕见疾病药物的商业保险产品。在药物集中采购期间，将实施激励政策以支持适合儿童的配方和规格的供应。</p>
</div><p>Editors: Tang Shihua, Futura Costaglione</p>
<div class="lb-trans"><p>编辑：唐诗华，Futura Costaglione</p>
</div>

中国将为创新儿童药物制造商提供最长两年的市场独占权