News Express: UM, Pharmaceutical Administration Bureau sign cooperation agreements on third-party technical assessment of proprietary Chinese medicines and testing of Chinese medicine
新聞快訊：澳大與藥監局簽署第三方中成藥技術審評及中藥檢測合作協議
雙方簽約
The signing of the agreements
澳大與藥監局簽署第三方中成藥技術審評及中藥檢測合作協議
澳門大學與澳門特別行政區政府藥物監督管理局簽署《澳門特別行政區政府藥物監督管理局與澳門大學關於第三方中成藥技術審評之合作協議》及《澳門特別行政區政府藥物監督管理局與澳門大學關於第三方中藥檢測之合作協議》。
澳大藥品監管科學研究中心成為藥監局認可的第三方中成藥註冊技術審評機構，可為澳門中成藥註冊申請人提供第三方審評服務，對有關中成藥的藥學、藥理毒理及臨床研究方面提供客觀專業的技術審評意見；澳大澳門中藥檢測中心則成為藥監局認可的第三方檢測機構，可以為澳門和海內外企業提供檢驗檢測服務，也可以為藥監局提供中成藥註冊檢驗及上市後監督檢驗服務。
在澳門特別行政區政府社會文化司司長歐陽瑜見證下，澳大校長宋永華與藥監局局長蔡炳祥簽署第三方中成藥技術審評及中藥檢測合作協議。有關協議將推動澳門中藥產業發展邁向新的里程碑，為保障澳門註冊中成藥的安全性、有效性及質量可控性共同把關。
宋永華表示，中醫藥是澳大極具特色且重點支持的領域，透過屬下的中藥質量研究國家重點實驗室、澳門中藥研發中心、澳門大學藥品監管科學研究中心等多個中藥科技創新與研究轉化平台，不斷探索中醫藥領域關鍵科學問題，將研究成果轉化為實際產品，並透過跨學科研究推動中醫藥的國際化與現代化，服務澳門中醫藥產業發展。當中，澳大澳門中藥檢測中心以服務澳門中藥事業發展為己任，以“發展澳門檢測，實現澳門認證，助力澳門中藥產業化和國際化發展”為目標，致力打造粵港澳大灣區質量檢測認證高地。澳大藥品監管科學研究中心聚焦監管科學及政策法律法規研究，以及為藥品及醫療器械評價及監管決策開發新的監管工具、標準和方法，透過加強中藥關鍵領域的監管科學研究，有助於推動中藥監管理念、制度與機制創新，強化成果轉化應用，加速新產品研發上市，並提升澳門及大灣區在醫療產品監管方面的能力。
蔡炳祥表示，為推動中藥傳承和創新，支持產業發展，藥監局切實執行中藥法，構建符合中醫藥特點的審評審批制度，並通過科學嚴謹的檢驗手段，監測藥物質量及安全性，及時發現不合格產品並採取適當的風險管理措施，從而保障公眾健康。此外，建立完善的藥物審評審批制度和檢驗檢測體系有助於增強廣大社會對澳門藥物及中藥產品的信心，對推動大健康產業發展具有重要意義。第三方審評及檢驗機構憑藉其專業性、獨立性及客觀性的特點，在保障產品安全和促進行業發展方面發揮重要的作用。澳大在中藥科研及教學方面成果顯著，藥監局期望透過第三方中成藥技術審評及中藥檢驗合作，與澳大共同努力，賦能中藥創新發展，促進更多中藥企業在澳門落戶，轉化更多中藥產品，助力推動澳門中醫藥大健康產業發展。
出席簽署儀式的人員還包括藥物監督管理局副局長李世恩、代副局長鄭艷紅，澳大中華醫藥研究院院長陳新、澳門中藥檢測中心主任李紹平、藥品監管科學研究中心主任胡元佳及副主任吳靄琳等。
欲瀏覽官網版可登入以下連結:
https://www.um.edu.mo/zh-hant/news-and-press-releases/presss-release/detail/59870/
UM, Pharmaceutical Administration Bureau sign cooperation agreements on third-party technical assessment of proprietary Chinese medicines and testing of Chinese medicine
The University of Macau (UM) and the Pharmaceutical Administration Bureau (ISAF) of the Macao SAR Government have signed a cooperation agreement on third-party technical assessment of proprietary Chinese medicines and a cooperation agreement on third-party testing of Chinese medicine.
Under the agreements, both the Centre for Pharmaceutical Regulatory Sciences (CPRS), UM, and the Macao Centre for Testing of Chinese Medicine (MCTCM), UM, will be third-party bodies recognised by ISAF. CPRS will provide third-party technical assessment services for the registration of proprietary Chinese medicines, and offer professional consultancy services covering the fields of pharmacy, pharmacology, toxicology, and clinical research. MCTCM will provide third-party Chinese medicine testing services for enterprises in Macao and beyond. It will also support the bureau with testing services for proprietary Chinese medicines upon registration and after launch.
In the presence of Ao Ieong U, secretary for social affairs and culture, Yonghua Song, rector of UM, and Choi Peng Cheong, president of ISAF, signed the cooperation agreements.
Song said that Chinese medicine is a distinctive and key area of focus for UM. Through various technology and research platforms, such as the State Key Laboratory of Quality Research in Chinese Medicine, Macao Centre for Research and Development in Chinese Medicine, and CPRS, the university continuously addresses scientific issues in Chinese medicine and translates research results into products. The university is also committed to promoting the internationalisation and modernisation of Chinese medicine through interdisciplinary research, thereby supporting the development of the Chinese medicine industry in Macao.
Choi highlighted the importance of third-party assessment and testing bodies in ensuring product safety and promoting industry development. He expressed hope that the cooperation between UM and ISAF will promote innovation in Chinese medicine, attract more Chinese medicine enterprises to Macao, and facilitate the development of more Chinese medicine products, thus contributing to the growth of the Chinese medicine and ‘big health’ industry in Macao.
To read the news on UM’s official website, please visit the following link:
https://www.um.edu.mo/news-and-press-releases/presss-release/detail/59870/