本文選題：罕見病 + 孤兒藥��； 參考：《中國藥學(xué)雜志》2017年08期

【摘要】：目的檢索國外上市孤兒藥品目錄,了解這些藥物在我國的上市情況,為提高我國孤兒藥可及性提供參考。方法計(jì)算機(jī)檢索已發(fā)布孤兒藥物管理政策的國家和地區(qū)(美國、新加坡、日本、澳大利亞、歐盟、中國臺灣地區(qū)和韓國)的官方藥品管理網(wǎng)站,按事先設(shè)計(jì)的數(shù)據(jù)提取表提取已上市孤兒藥品信息。檢索中國國家食品藥品監(jiān)督管理局網(wǎng)站,查詢這些藥品在我國的上市和報(bào)銷現(xiàn)狀。藥品分類參照《中國藥典》(2010年版),疾病分類參照《疾病和有關(guān)健康問題的國際統(tǒng)計(jì)分類》(ICD-10),醫(yī)保信息參照《國家基本醫(yī)療保險、工傷保險和生育保險藥品目錄》(2009年版)。結(jié)果美國、日本、澳大利亞和歐盟出臺孤兒藥目錄,上市藥物共1 133種,覆蓋疾病類別26個。抗腫瘤藥物,內(nèi)分泌、營養(yǎng)和代謝疾病用藥,血液系統(tǒng)疾病用藥位列前三,分別為329種、168種和122種,占所有藥物的29.04%、14.83%和10.77%。中國近十年進(jìn)口國外孤兒藥數(shù)量持續(xù)增長,但數(shù)量不及國外上市三成,上市數(shù)量最多的為抗腫瘤藥物、抗傳染病和寄生蟲病用藥及內(nèi)分泌、營養(yǎng)和代謝疾病用藥。醫(yī)保報(bào)銷目錄中覆蓋孤兒藥33種,含甲類5種,乙類28種,占西藥報(bào)銷品種數(shù)的2.9%。結(jié)論我國進(jìn)口孤兒藥數(shù)量雖不斷增加,但與國外差距明顯。為提高孤兒藥物的可獲得性和可負(fù)擔(dān)性,保障罕見病患者權(quán)益,我們建議國家相關(guān)部門:(1)盡快出臺孤兒藥物管理政策;(2)循證遴選進(jìn)口孤兒藥物清單,建立適合本國國情的孤兒藥目錄;(3)建立孤兒藥進(jìn)口審批綠色通道,縮短進(jìn)口時間;(4)激勵本土企業(yè)的研發(fā)積極性,重視孤兒藥的研發(fā)與仿制。
[Abstract]:Objective to retrieve the list of foreign listed orphan drugs, to understand the listing of these drugs in China, and to provide reference for improving the availability of orphan drugs in China. Methods the official drug management of countries and regions (USA, Singapore, Japan, Australia, EU, Taiwan region and South Korea) that have published orphan drug management policies have been published by computer. The website, according to the pre designed data extraction table to extract the information of the orphan drugs on the market, search the website of the national food and Drug Administration of China, inquire about the status of the listed and reimbursed drugs in our country. The classification reference of the Chinese Pharmacopoeia (2010 Edition), the disease classification reference < disease and the international statistical classification of health problems > (ICD-10) The medical insurance information refer to the national basic medical insurance, the industrial injury insurance and the birth insurance drug catalogue (2009 Edition). Results the United States, Japan, Australia and the European Union issued the orphan drug catalogue, 1133 kinds of listed drugs, covering 26 disease categories, antitumor drugs, endocrine, nutritional and metabolic diseases, and the top three of the blood system diseases. 329, 168 and 122 kinds, accounting for 29.04%, 14.83% and 10.77%. of all drugs, the number of imported foreign orphans continued to grow in China for the last ten years, but the number was less than 30% abroad. The largest number of drugs listed in the market were antitumor drugs, anti infectious and parasitic diseases, endocrine, nutritional and metabolic drugs. There are 33 kinds of orphan drugs, including 5 kinds of class A, 28 kinds of class B, 28 kinds of class B, accounting for the number of Western medicine reimbursement. Although the number of imported orphan drugs in China is increasing, the gap with the foreign countries is obvious. In order to improve the availability and affordability of orphan drugs and protect the rights and interests of the patients with rare diseases, we propose the relevant state departments of the state: (1) the administration of orphan drug administration as soon as possible. Policy: (2) to select the list of imported orphans, establish an orphan drug list suitable for the national conditions of the country, and (3) establish a green passage for the approval of the import of orphan drugs, shorten the time of import, and (4) encourage the R & D enthusiasm of local enterprises, and attach importance to the research and development and imitation of orphan drugs.
【作者單位】： 四川大學(xué)華西第二醫(yī)院藥學(xué)部循證藥學(xué)中心;出生缺陷與相關(guān)婦兒疾病教育部重點(diǎn)實(shí)驗(yàn)室;新疆石河子大學(xué)藥學(xué)院;
【基金】：國家自然科學(xué)基金資助項(xiàng)目(81373381):中國兒童合理用藥評價指標(biāo)體系的循證研究 四川大學(xué)華西第二醫(yī)院新芽基金(kx034)
【分類號】：R95

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