2017 APEC

Taiwan Food and Drug Administration (TFDA) in collaboration with Japan in APEC Life Science Innovation Forum - Regulatory Harmonization Steering Committee (LSIF-RHSC) promotes Good Registration Management (GRM). A memorandum of understanding (MOU) was signed between TFDA and APEC LSIF in July 2017, and TFDA is an APEC Training Center of Excellence (CoE) in Regulatory Science in the area of Good Registration Management. TFDA hosts “2017 APEC Good Registration Management Regulatory Science Center of Excellence Workshop” in National Taiwan University Hospital (NTUH) International Convention Center in Taipei from October 31 to November 2. APEC LSIF-RHSC, Pharmaceuticals and Medical Devices Agency (PMDA), Asia Partnership Conference of Pharmaceutical Associations (APAC), Regulatory Affairs Professionals Society (RAPS), Ching Kang Foundation for Pharmacy Promotion and National Yang Ming University are the primary co-organizers.
This workshop is a 3-day training program with Common sessions, Reviewer-Specific Sessions, and Applicant-Specific Sessions to offer the participants the concept of GRM through training regulators from different APEC member economies. 117 participants from 13 different countries to attend this workshop; they are mainly from regulatory authorities and industry. There are 35 invited speakers from Japan, Canada, UK, Singapore, Philippine and Taiwan. In addition, there are 70 trainees from 10 different APEC economies including Hong Kong, Indonesia, Korea, Malaysia, Papua New Guinea, Philippine, Singapore, Thailand and Vietnam.   

食品藥物管理署(簡稱食藥署) 於APEC法規協和指導委員會(LSIF-RHSC)中與日本合作，共同推動優良查驗登記管理(Good Registration Management，簡稱GRM)，並於106年7月與APEC完成合作備忘錄的簽署，正式成為APEC認可的優良查驗登記管理法規科學卓越中心。為促進APEC區域醫藥品查驗登記品質與效率的提升，食藥署訂於106年10月31日至11月2日在台大醫院國際會議中心舉辦第一場訓練活動，名為2017 APEC優良查驗登記管理法規科學卓越中心(Center of Excellence，簡稱CoE)研討會，本次協辦單位包括APEC LSIF-RHSC、日本醫藥品醫療機器綜合機構(PMDA)、亞洲製藥協會聯合會議(APAC)、RAPS台灣分會、景康藥學基金會及國立陽明大學。
此次規劃三天的訓練課程，包括共同課程及針對審查人員及查驗登記申請人所規劃的專屬課程，以推廣優良查驗登記管理的觀念，並培訓APEC會員國的優良查驗登記管理種子師資，以增進區域法規協和，共有13個國家的產官學界參與，總人數為117人 。除我國外，還邀請來自日本、加拿大、英國、新加坡及菲律賓等國的講師及與談人，所有講師人數共35名 ；參與的學員分別來自10個APEC會員經濟體，包括香港、印尼、韓國、馬來西亞、巴布亞新幾內亞、菲律賓、新加坡、泰國及越南，總數為70名 。
透過本次研討會，優良查驗登記管理CoE工作小組將蒐集受邀講師及學員的回饋意見，以精進優良查驗登記管理種子師資培訓的課綱及內容。食藥署長期參與APEC LSIF-RHSC，透過主辦APEC優良查驗登記管理法規科學卓越中心，期許提升藥品查驗登記的品質與效率，縮短創新產品上市時程，嘉惠民眾。