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盧寵茂:下月設「1+」機制審批新藥

盧寵茂:下月設「1+」機制審批新藥

Ta Kung Pao
Friday, October 27, 2023 07:12:48 AM UTC

  盧寵茂表示,本港已經申請了以觀察員身分加入國際醫藥法規協和會(ICH),並獲國家藥監局支持。當局會在明年內成立香港藥械監管中心的籌備辦公室,並適時由「1+」機制轉為第一層審批,屆時不再需要經由其他藥物評審機構認可,可以主動評核臨床數據,評審藥物。

  盧寵茂預料,香港要成為ICH的成員,讓在港註冊的藥物受到國際認同,大約需要8至10年時間。

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