To promote the quality and efficiency of good registration management (GRM) for medicinal products and facilitate regulatory harmonization in the Asia-Pacific region, Taiwan Food and Drug Administration (TFDA) hosts "2019 APEC GRM Regulatory Science Center of Excellence (CoE) Workshop" from September 17th to 19th, 2019 in Taipei. A total of 21 experts from domestic and foreign regulatory authorities and pharmaceutical industries, such as U.S.A, Denmark, Canada, Japan, Singapore and Taiwan, are invited to share their experiences with and deliver training courses to 67 trainees from 12 APEC member economies with regard to the dissemination of the GRM concepts. The total number of participants is 173, including participants from 16 APEC member economies and 1 European Union member state.

TFDA has long been participating in the APEC LSIF-RHSC to promote the regulatory convergence. In July 2017, TFDA and RAPS Taiwan Chapter were formally regarded as an APEC Regulatory Science Training CoE in the area of GRM. Since then, TFDA has been hosting the training events for the third consecutive year in Taiwan. In the future, TFDA will keep hosting the GRM training courses to achieve the goal of promoting regulatory convergence, capacity development and international cooperation.

為促進APEC亞太區域醫藥品查驗登記品質與效率的提升，並增進區域法規協和，衛生福利部食品藥物管理署(以下簡稱食藥署)於108年9月17至19日在臺北舉辦為期3天的「2019 APEC優良查驗登記管理法規科學卓越中心(Good Registration Management Regulatory Science Center of Excellence Workshop, GRM CoE)研討會」，邀請21位國內外藥品衛生主管機關代表及業界專家參與授課，培訓67名來自12個APEC會員經濟體的產官學界種子師資，未來將於亞太區域內共同推廣優良查驗登記管理的法規科學培訓，促進醫藥品查驗登記優良送件及優良審查的落實及接軌。

本研討會為APEC生命科學創新論壇(LSIF)法規協和指導委員會(RHSC)認可的訓練活動，由食藥署主辦，會中邀請美國衛生主管機關U.S.FDA、加拿大衛生主管機關Health Canada、丹麥衛生機關Danish Medicines Agency、日本衛生主管機關PMDA、新加坡羅氏藥廠等官方代表及國際藥業專家擔任講師，分享優良查驗登記管理的原則及實務經驗，並探討如何應用於藥品的全生命週期管理。參與學員來自汶萊、智利、香港、印尼、韓國、馬來西亞、巴布亞新幾內亞、秘魯、菲律賓、泰國、越南及我國等12國，與會總人數173人。

APEC是亞太地區最重要的多邊官方經濟合作論壇之一，食藥署長期參與APEC LSIF-RHSC所倡議之區域法規調和，並於106年7月正式被認可為「APEC優良查驗登記管理法規科學訓練卓越中心」。未來食藥署將在APEC LSIF的合作備忘錄下持續辦理培訓課程，以達本署促進法規協和、能力建設及交流合作之目標。