省藥品監督管理局副局長(cháng)陳魁、浙江省藥學(xué)會(huì )理事長(cháng)朱志泉帶隊調研浙江省藥品MAH轉化平臺
- 2022-01-14
- 歌文達生物醫藥
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2022年1月13日上午,浙江省藥品監督管理局副局長(cháng)陳魁、浙江省藥學(xué)會(huì )理事長(cháng)朱志泉帶隊調研浙江省藥品MAH轉化平臺,與平臺及代表會(huì )員企業(yè)和澤醫藥就MAH實(shí)踐經(jīng)驗及存在的問(wèn)題進(jìn)行了深入探討與溝通。杭州醫藥港黨工委副書(shū)記、管理辦公室主任盧建軍出席了會(huì )議。MAH制度從2015年開(kāi)始試點(diǎn),2019年12月1日正式落地實(shí)施,浙江省藥監局副局長(cháng)陳魁提到,對監管機構來(lái)說(shuō),MAH制度還是一個(gè)新鮮事物,在我國仍處于“鼓勵發(fā)展,政策配套”的階段。但 2 年的實(shí)施已經(jīng)可以看到MAH給整個(gè)行業(yè)帶來(lái)了活力和變革,截至目前,浙江省已批準30多個(gè)B證(藥品生產(chǎn)許可證)。當然在MAH實(shí)踐過(guò)程中,還有很多值得探索和研究的環(huán)節,浙江省藥品MAH轉化平臺(以下簡(jiǎn)稱(chēng):平臺)政策研究先行,通過(guò)扎實(shí)的課題研究為監管機構提供一定的數據支撐,是非常有意義的。座談會(huì )上,浙江省藥學(xué)會(huì )理事長(cháng)朱志泉對平臺提出要求,并期望平臺未來(lái)在為政府服務(wù)方面發(fā)揮更大的作用。平臺現已有1300余家會(huì )員企業(yè),以服務(wù)全省醫藥產(chǎn)業(yè)、助力醫藥產(chǎn)業(yè)上市許可轉化,促進(jìn)醫藥經(jīng)濟發(fā)展為宗旨,是為藥品上市許可持有人提供藥品持證轉化服務(wù)的非盈利性綜合服務(wù)平臺。后續,平臺將加強MAH相關(guān)課題研究,為監管機構建言獻策,共同推動(dòng)我國MAH制度的發(fā)展。浙江省藥品監督管理局藥品生產(chǎn)處吳悅、藥品檢查中心李金和、浙江省藥學(xué)會(huì )秘書(shū)長(cháng)楊蘇蓓,副秘書(shū)長(cháng)周劍輝等出席了會(huì )議。
轉載自:浙江省藥品MAH轉化平臺公眾號
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