Date: September 26 -28, 2018

NEWSTaiwan FDA hosts 2018 APEC GRM CoE Workshop

Taiwan Food and Drug Administration (TFDA) hosts 2018 APEC Good Registration Management Regulatory Science Center of Excellence Workshop at the venue of Taipei Nangang Exhibition Center from September 26th to 28th. This is a training event under the auspices of APEC Life Science Innovation Forum (LSIF) Regulatory Harmonization Steering Committee (RHSC). The 3-day workshop program followed the core curriculum of previous years and trained 62 trainees from Chile, Hong Kong, Indonesia, Japan, Korea, Malaysia, Mexico, Papua New Guinea, Peru, Philippines, Singapore, Taiwan, Thailand and Vietnam, a total of 14 APEC member economies. The objective is to train more trainers for disseminating the concept of good registration management (GRM) in individual APEC member economies. 28 international experts were invited to deliver training in good review practices or good submission practices, including experts from German regulatory authority BfArM, Japan regulatory authority PMDA, UK regulatory authority MHRA, and several other institutions. The total number of participants was 125, including participants from 15 APEC member economies and 2 European Union member countries. This workshop is hosted by TFDA and co-organized by Regulatory Affairs Professionals Society (RAPS) Taiwan Chapter, APEC LSIF-RHSC, Pharmaceutical and Medical Device Agency (PMDA) and Asia Partnership Conference of Pharmaceutical Associations (APAC). APEC is a premier economic forum in the Asia-Pacific region. TFDA has long been participating in the APEC LSIF-RHSC to promote (GRM). In July 2017, TFDA and RAPS Taiwan Chapter formally became an APEC Regulatory Science Training Center of Excellence in the area of GRM. Since then, the CoE has delivered an annual training event with focus on the best practices of good review and good submission. Established by APEC Leaders in 2002, the LSIF has since grown to become APEC's leading initiative on health and health sciences innovation. The LSIF Leadership recognizes Taiwan’s important contributions to the LSIF workstreams over the years and nominates Minister Shih-Chung Chen of the Ministry of Health and Welfare to succeed the chair of the LSIF Executive Board in August 2018. Hosting this event has deepened and consolidated Taiwan’s international relations through capacity building, exchanges and cooperation, and added another highlight in Taiwan’s pharmaceuticals affairs after becoming an official member of ICH this year.

Minister of Health and Welfare Chen Shih-Chung (陳時中, middle of the front row) and TFDA
Director General Wu Shou-Mei (吳秀梅, front row, third from the right) joined other experts from
domestic and foreign regulatory authorities and pharmaceutical industries at the 2018 APEC
GRM CoE Workshop

Group photo of all participants at the 2018 APEC GRM CoE Workshop



【NEWS】食藥署舉辦「2018 APEC優良查驗登記管理法規科學卓越中心(GRM CoE)研討會」

衛生福利部食品藥物管理署(以下簡稱食藥署)於107年9月26至28日在台北舉辦為期三天的「2018 APEC優良查驗登記管理(Good Registration Management)法規科學卓越中心研討會」,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,107年活動沿用往年的核心課綱,培訓62名來自智利、香港、印尼、日本、韓國、馬來西亞、墨西哥、巴布亞新幾內亞、秘魯、菲律賓、新加坡、泰國、我國及越南等14個APEC會員經濟體的產官學界種子師資,以協助於亞太區域內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。
除食藥署外,本次研討會由RAPS台灣分會、APEC LSIF-RHSC、日本醫藥品醫療機器綜合機構(PMDA)及亞洲製藥協會聯盟(APAC)等組織共同籌備,邀請國際藥品法規專家28人參與授課,其中包括德國衛生主管機關BfArM、英國衛生主管機關MHRA及日本衛生主管機關PMDA的專家代表,總與會人數125人,共來自15個APEC會員經濟體及2個歐盟成員國。 APEC為亞太地區重要的經濟諮商論壇,食藥署長期參與APEC LSIF-RHSC所倡議之區域法規調和相關工作,與日本MHLW/PMDA合作推動優良查驗登記管理,並與美國醫療法規學會(RAPS)台灣分會聯名於106年7月正式成為「APEC優良查驗登記管理法規科學訓練卓越中心」。此為我國首例獲APEC認可之法規科學訓練卓越中心,透過辦理優良查驗登記管理與相關規範的教育訓練,促進醫藥品查驗登記品質及時效的提升,並促進區域法規協和。LSIF是由APEC領袖於91年成立,現已發展成為APEC在衛生及衛生科學創新方面的領先倡議,該論壇高度重視我國多年來的重要貢獻,於107年提名衛生福利部陳時中部長接任LSIF執行委員會主席。在我國外交頻受困頓之際,此活動突破國際疆界,以藥品法規及查驗登記管理與各國互動交流,深化與鞏固國際關係,而在繼我國成為ICH之正式會員外,實為專業外交加添另一大亮點與重大突破。


2018 APEC優良查驗登記管理法規科學卓越中心研討會全體與會者大合照