<p>（第一財經）5 月 8 日——中國將給予符合條件的創新兒科藥物製造商最長兩年的市場獨佔期，以鼓勵兒科藥物的研發並支持創新。</p>
<p>除了市場獨佔期，國家衞生健康委員會和其他七個中國部委昨日發佈的新政策還引入了符合特定要求的兒科藥物的專利期限補償。</p>
<p>該政策是中國 2014 年發佈的首個全面確保兒科藥物可用性的政策文件的首次更新，將重點支持針對常見兒童疾病的創新藥物研發、組合疫苗、適合兒科藥物的配方以及兒童罕見疾病的治療。</p>
<p>對於指定的創新兒科治療，監管機構將通過早期干預、協調審查流程和滾動提交，幫助開發者持續提高藥物開發的效率。</p>
<p>政府將鼓勵研究新的工具、方法和兒科藥物監管標準，並探索建立國家兒科臨牀試驗協作網絡和跨機構倫理審查機制的可能性，以應對兒科藥物開發效率低和招募參與者等挑戰。</p>
<p>監管機構還承諾支持在多中心協作模式下增強真實世界證據和前瞻性研究設計，以及將現有藥物安全數據從成人羣體推斷到中國的兒科人羣。</p>
<p>此外，監管機構將優先審查和批准納入鼓勵創新兒科藥物和仿製藥名單的藥物註冊申請，並加快其納入國家基本藥物目錄的進程。</p>
<p>國家衞生健康委員會將與國家藥品監督管理局共同制定醫療機構常用兒科配方藥物的清單，針對臨牀必要但市場上缺乏或沒有兒科特定配方和劑量的藥物。同時，將主導制定兒科藥物的臨牀應用指南，並探索制定兒童國家基本藥物目錄。</p>
<p>監管機構將支持為兒童開發覆蓋創新藥物和罕見疾病藥物的商業保險產品。在藥物集中採購期間，將實施激勵政策以支持適合兒童的配方和規格的供應。</p>
<p>編輯：唐詩華，Futura Costaglione</p>

納斯達克中國金龍指數

中國龍 ETF - Roundhill

中概股 ETF - PowerShares

中國 MSCI ETF - iShares

<p>中國將向符合條件的創新兒科藥物製造商提供最長兩年的市場獨佔權，以促進兒科藥物的研發。國家衞生健康委員會及其他部門發佈的新政策還引入了專利期限補償，旨在支持常見兒童疾病和罕見疾病的治療發展。監管機構將協助提高藥物開發效率，並優先處理創新兒科藥物的註冊申請。此外，政府將探索國家兒科臨牀試驗網絡，並支持兒童商業保險產品的開發</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>（第一財經）5 月 8 日——中國將給予符合條件的創新兒科藥物製造商最長兩年的市場獨佔期，以鼓勵兒科藥物的研發並支持創新。</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>除了市場獨佔期，國家衞生健康委員會和其他七個中國部委昨日發佈的新政策還引入了符合特定要求的兒科藥物的專利期限補償。</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>該政策是中國 2014 年發佈的首個全面確保兒科藥物可用性的政策文件的首次更新，將重點支持針對常見兒童疾病的創新藥物研發、組合疫苗、適合兒科藥物的配方以及兒童罕見疾病的治療。</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>對於指定的創新兒科治療，監管機構將通過早期干預、協調審查流程和滾動提交，幫助開發者持續提高藥物開發的效率。</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>政府將鼓勵研究新的工具、方法和兒科藥物監管標準，並探索建立國家兒科臨牀試驗協作網絡和跨機構倫理審查機制的可能性，以應對兒科藥物開發效率低和招募參與者等挑戰。</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>監管機構還承諾支持在多中心協作模式下增強真實世界證據和前瞻性研究設計，以及將現有藥物安全數據從成人羣體推斷到中國的兒科人羣。</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，監管機構將優先審查和批准納入鼓勵創新兒科藥物和仿製藥名單的藥物註冊申請，並加快其納入國家基本藥物目錄的進程。</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>國家衞生健康委員會將與國家藥品監督管理局共同制定醫療機構常用兒科配方藥物的清單，針對臨牀必要但市場上缺乏或沒有兒科特定配方和劑量的藥物。同時，將主導制定兒科藥物的臨牀應用指南，並探索制定兒童國家基本藥物目錄。</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>監管機構將支持為兒童開發覆蓋創新藥物和罕見疾病藥物的商業保險產品。在藥物集中採購期間，將實施激勵政策以支持適合兒童的配方和規格的供應。</p>
</div><p>Editors: Tang Shihua, Futura Costaglione</p>
<div class="lb-trans"><p>編輯：唐詩華，Futura Costaglione</p>
</div>

中國將為創新兒童藥物製造商提供最長兩年的市場獨佔權