News Express: UM, Pharmaceutical Administration Bureau sign cooperation agreement, recognising MITMI as third-party technical assessment body for proprietary Chinese medicines
新聞快訊：澳大與藥監局簽署第三方中成藥技術審評合作協議
簽約儀式
The agreement signing ceremony
澳大與藥監局簽署第三方中成藥技術審評合作協議
澳門特別行政區政府藥物監督管理局與澳門大學澳門轉化醫學創新研究院簽署《第三方中成藥技術審評之合作協議》，研究院成為藥監局認可的第三方中成藥註冊技術審評機構，可為本澳中成藥註冊申請人的藥學研究資料、藥理毒理學研究資料及臨床研究資料進行技術審評並出具審評報告。
在簽署儀式上，中國工程院院士、廣州實驗室主任、澳門大學澳門轉化醫學創新研究院指導委員會主席鍾南山表示，研究院的成立恰逢澳門特區政府頒佈《中藥藥事活動及中成藥註冊法》及成立藥監局，有利於澳門經濟適度多元化發展。藥監局成立至今做了大量工作，為澳門中藥發展奠定良好基礎。國家積極推動中醫藥高質量發展，鍾院士希望在保障中藥安全、有效及質量可控的前提下，通過中醫藥理論、人用經驗及臨床試驗相結合的評審證據體系，在澳門探索具有中醫藥特色的監管之路，對外打造澳門成為“中藥出海”的橋頭堡。
藥監局局長蔡炳祥表示，澳門特區政府致力推動中醫藥大健康產業發展，切實執行《中藥藥事活動及中成藥註冊法》，構建符合中醫藥理論與特點的審評審批制度，促進中藥傳承和創新，支持產業發展。中藥創新藥轉化是推進澳門大健康產業發展的切入口之一，藥監局重視人用經驗對中藥安全性以及有效性的支持作用，鼓勵已具有豐富人用經驗的醫院製劑及配方源自兩院院士或國醫大師的製劑在澳門落地轉化。他又指，澳大在中藥科研及教學方面成果顯著，研究院致力於中藥創新及轉化，並擁有豐富中藥審評經驗的專家團隊，藉著與研究院簽署合作協議，研究院出具的審評報告能為藥監局的中藥審評提供參考。
澳大副校長葛偉表示，澳大全力配合澳門特區政府的總體發展規劃，積極發揮粵澳科研與產業轉化方面的橋樑作用，協助轉化澳門及內地的中藥科研項目；同時，澳大在深化中醫藥交流合作及市場推廣等方面亦取得了積極進展。葛偉希望研究院成為藥監局的第三方中成藥技術審評機構後，能為創新中成藥註冊提供優質的第三方技術審評意見。澳大會支持研究院的技術審評工作，為中成藥落地轉化作出更大的貢獻。
出席簽署儀式的人員還有：藥物監督管理局副局長吳國良及李世恩、規劃及質量管理廳廳長劉雅文、註冊廳廳長李志洋及中藥處處長林富聰；澳門大學澳門轉化醫學創新研究院指導委員會委員鍾惟月、楊子峰（廣州醫科大學附屬第一醫院/廣州呼吸健康研究院副院長）、代副院長趙永華；經濟及科技發展局副局長龐啓富；澳門科學技術發展基金行政委員會委員葉桂林；廣州醫科大學藥學院院長余細勇；上海中醫藥大學教授張磊；中山陳星海中西醫結合醫院院長黃漢偉；粵澳合作中醫藥科技產業園副總經理王丹等。
欲瀏覽官網版可登入以下連結:
https://www.um.edu.mo/zh-hant/news-and-press-releases/press-release/detail/57652/
UM, Pharmaceutical Administration Bureau sign cooperation agreement, recognising MITMI as third-party technical assessment body for proprietary Chinese medicines
The Pharmaceutical Administration Bureau of the Macao SAR Government and the Macau Institute for Translational Medicine and Innovation (MITMI) of the University of Macau (UM) have signed a cooperation agreement for the third-party technical assessment of propriety Chinese medicines. According to the agreement, MITMI is recognised by the bureau as a third-party technical assessment body for the registration of proprietary Chinese medicines. It can carry out technical assessments on the information of pharmacological studies, pharmacological and toxicological studies, and clinical studies submitted by applicants for the registration of proprietary Chinese medicines in Macao and issue assessment reports.
At the signing ceremony, Zhong Nanshan, member of the Chinese Academy of Engineering, director of the Guangzhou Laboratory, and chairman of the Steering Committee of MITMI, said that MITMI will contribute to Macao’s economic diversification. He hopes that, under the premise of guaranteeing the safety, efficacy, and quality control of traditional Chinese medicine (TCM), and through an evidence-based assessment system that combines TCM theories, practical experiences, and clinical trials, MITMI will facilitate the development of TCM regulations in Macao and develop the city into a bridgehead for TCM to go global. Choi Peng Cheong, president of the Pharmaceutical Administration Bureau, said that the Macao SAR Government is committed to promoting the development of TCM and health industries, as demonstrated by initiatives such as the implementation of the Law on Pharmaceutical Activities in Traditional Chinese Medicine and Registration of Proprietary Chinese Medicines. He pointed out that the commercialisation of innovative TCM is one of the entry points for promoting Macao’s health industry, adding that UM has achieved remarkable results in research and teaching of TCM and the TCM assessment reports issued by MITMI will serve as a reference for the bureau. Ge Wei, vice rector of UM, said that UM actively plays the role of a bridge between Guangdong and Macao in scientific research and industrial transformation, and facilitates the commercialisation of TCM research projects in Macao and mainland China. He hopes that MITMI will provide quality third-party technical assessments for the registration of innovative proprietary Chinese medicines.
To read the news on UM’s official website, please visit the following link:
https://www.um.edu.mo/news-and-press-releases/press-release/detail/57652/