國外兒科藥物研發(fā)的監(jiān)管要求和研發(fā)策略
發(fā)布時(shí)間：2018-08-18 13:17
【摘要】：從歷史上看,藥物用于兒童時(shí)通常沒有獲得像成人藥物一樣的安全性和有效性證據(jù)。隨著人們對(duì)全球藥品監(jiān)管有關(guān)兒科藥物研發(fā)互動(dòng)協(xié)調(diào)的關(guān)注的不斷增長,同時(shí)對(duì)兒童遺傳性罕見病也給予了越來越多的支持和關(guān)注,盡早和監(jiān)管機(jī)構(gòu)接觸的期望日漸增高。歐盟和美國的法律都強(qiáng)制性要求進(jìn)行和支持兒科藥物研發(fā),同時(shí)包括隨之而來的經(jīng)濟(jì)利益,即延長兒科用藥的專利保護(hù)。在提交上市許可申請(qǐng)之前,歐盟兒科法規(guī)要求制藥公司申請(qǐng)人與歐洲藥品管理局(EMA)達(dá)成兒科研究計(jì)劃的協(xié)議,而目前美國有4個(gè)兒科藥物研發(fā)相關(guān)的法律,提出了兒科研究計(jì)劃的要求。世界衛(wèi)生組織推出了"量身定制兒童藥物"的倡議。對(duì)于全球性藥物開發(fā)項(xiàng)目,明智的做法是盡可能早地尋求歐盟EMA和美國FDA有關(guān)兒科藥物研發(fā)計(jì)劃的科學(xué)建議,并達(dá)成協(xié)議。
[Abstract]:Historically, drugs have been used in children without evidence of the same safety and efficacy as adult drugs. With the increasing attention to the interaction and coordination of paediatric drug research and development in global drug regulation, more and more support and attention has been paid to the rare genetic diseases in children, and the expectation of early contact with regulators is increasing. European Union and U.S. laws require and support paediatric drug development, including the attendant economic benefits of extending patent protection for paediatric drugs. Before filing for a listing license, EU paediatric regulations require pharmaceutical company applicants to enter into a paediatric research program agreement with the European Drug Administration (EMA), while there are currently four paediatric drug development laws in the United States. The requirements of the pediatric research program are put forward. The World Health Organization has launched a child-specific drug initiative. For a global drug development program, it would be wise to seek scientific advice from the European Union's EMA and the U.S. FDA on paediatric drug development plans as soon as possible and reach an agreement.
【作者單位】： 國家食品藥品監(jiān)督管理總局藥品審評(píng)中心;Toxicology
【分類號(hào)】：R95
本文編號(hào)：2189583
[Abstract]:Historically, drugs have been used in children without evidence of the same safety and efficacy as adult drugs. With the increasing attention to the interaction and coordination of paediatric drug research and development in global drug regulation, more and more support and attention has been paid to the rare genetic diseases in children, and the expectation of early contact with regulators is increasing. European Union and U.S. laws require and support paediatric drug development, including the attendant economic benefits of extending patent protection for paediatric drugs. Before filing for a listing license, EU paediatric regulations require pharmaceutical company applicants to enter into a paediatric research program agreement with the European Drug Administration (EMA), while there are currently four paediatric drug development laws in the United States. The requirements of the pediatric research program are put forward. The World Health Organization has launched a child-specific drug initiative. For a global drug development program, it would be wise to seek scientific advice from the European Union's EMA and the U.S. FDA on paediatric drug development plans as soon as possible and reach an agreement.
【作者單位】： 國家食品藥品監(jiān)督管理總局藥品審評(píng)中心;Toxicology
【分類號(hào)】：R95
【相似文獻(xiàn)】
相關(guān)期刊論文 前1條
1 袁秉祥;陳莉娜;王冰;;復(fù)方藥品創(chuàng)新研發(fā)策略[J];中國臨床藥理學(xué)與治療學(xué);2013年10期
相關(guān)會(huì)議論文 前2條
1 呂揚(yáng);;晶型藥物研發(fā)策略[A];首屆中國晶型藥物研發(fā)技術(shù)學(xué)術(shù)研討會(huì)會(huì)議學(xué)術(shù)資料[C];2009年
2 杜冠華;;抗AD天然藥物研發(fā)策略及現(xiàn)狀[A];2013年全國老年性癡呆與相關(guān)疾病學(xué)術(shù)會(huì)議論文匯編[C];2013年
相關(guān)重要報(bào)紙文章 前1條
1 Bruce Booth 編譯 施櫻子;高盛青睞的藥物暗示了什么(下)[N];醫(yī)藥經(jīng)濟(jì)報(bào);2014年
，本文編號(hào)：2189583
本文鏈接：http://sikaile.net/yixuelunwen/yiyaoxuelunwen/2189583.html
最近更新
教材專著
