發(fā)布時間：2018-02-25 08:50

  本文關(guān)鍵詞： 罕見病 孤兒藥 綜合措施 政策建議　出處：《國際藥學(xué)研究雜志》2017年02期 　論文類型：期刊論文

【摘要】：孤兒藥可及性問題已得到各國的高度關(guān)注,很多國家和地區(qū)從20世紀(jì)80年代開始就制定了專門的法律法規(guī)以促進(jìn)其開發(fā)。目前孤兒藥研發(fā)已成為各大制藥公司進(jìn)行產(chǎn)品開發(fā)的重要策略。中國目前尚未定義罕見病,孤兒藥幾乎完全依賴進(jìn)口,其研發(fā)、引進(jìn)、生產(chǎn)及銷售等缺乏政策支持,已成為制約國家相關(guān)產(chǎn)業(yè)發(fā)展的瓶頸。本文擬對國內(nèi)外罕見病及其治療藥物的發(fā)展現(xiàn)狀作一綜述,并對中國的孤兒藥研發(fā)提出相應(yīng)的建議,以期為國家相關(guān)部門制定政策提供一定參考。
[Abstract]:The issue of access to orphan drugs has received a high degree of attention from all countries, Since 1980s, many countries and regions have enacted special laws and regulations to promote their development. At present, orphan drug research and development has become an important strategy for major pharmaceutical companies to develop their products. China has not yet defined rare diseases. Orphan drugs are almost completely dependent on imports. The lack of policy support in research, development, introduction, production and marketing has become a bottleneck restricting the development of related industries in the country. This paper will review the development status of rare diseases and their therapeutic drugs at home and abroad. Some suggestions on the development of orphan drugs in China are put forward in order to provide some references for the relevant government departments to formulate policies.
【作者單位】： 軍事醫(yī)學(xué)科學(xué)院毒物藥物研究所;國家衛(wèi)生計(jì)生委醫(yī)療管理服務(wù)指導(dǎo)中心;
【基金】：國家重點(diǎn)研發(fā)計(jì)劃精準(zhǔn)醫(yī)學(xué)研究重點(diǎn)專項(xiàng)“罕見病臨床隊(duì)列研究”資助項(xiàng)目(2016YFC0901500)
【分類號】：R95

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本文編號：1533752