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Workshop on 醫療器材優良流通規範(GDP)說明會

AmCham Taipei Medical Devices Committee held a luncheon on August 9 at The Sherwood Taipei to discuss and strengthen understanding of Good Distribution Practice (GDP) for Medical Devices.

Workshop title: 醫療器材優良流通規範(GDP)說明會

*This event was conducted in Mandarin. 本次活動將以中文進行。

衛生福利部食品藥物管理署(食藥署)已於104年6月18日公告我國醫療器材優良流通規範(Good Distribution Practice, GDP),來健全醫療器材販賣業者之管理,並維護醫療器材產品上市後流通安全,以確保醫療器材儲存、運輸、配送與販售過程中,產品品質符合原製造業者之規定要求。

為加強商會會員對於GDP之了解,並希望內容方向更切合在台外商公司,台北市美國商會邀請到金屬工業研究發展中心驗證組 蕭工程師蒞臨說明會擔任主講人,內容將介紹我國醫材GDP目前推動情形、GDP規範條文等相關說明,並邀請食藥署風管組 王副組長淑芬及 陳簡任技正瑜絢與會參與討論及接受提問,歡迎會員踴躍參加。

When: August 9, 2017 (9 AM – 12 PM)

Where: The Sherwood Taipei

Speaker: 蕭碧瑩 – 財團法人金屬工業研究發展中心 驗證組 工程師

From left to right: 陳簡任技正瑜絢-衛生福利部食品藥物管理署風管組、王副組長淑芬-衛生福利部食品藥物管理署風管組蕭碧瑩工程師 – 財團法人金屬工業研究發展中心驗證組, Cerline Tsai, AmCham Medical Devices Committee Task Force Leader, Manager, RA/QA & Reimbursement, Abbott Vascular

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Taiwan Biotech Industry Heats Up

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Biotech is hot in Taiwan, with a number of high profile companies emerging over the past few years with significant market capitalizations on the promise of bold new drugs and the incoming administration of Tsai Ing-wen promising even greater support.

At the AmCham Medical Devices, Pharmaceutical, and Public Health Joint Committee Luncheon on April 19, Dr. Chi Wei-kuang, Director and Distinguished Scientist of Bioengineering Group at the Development Center for Biotechnology (DCB) shared “Taiwan’s vision and current stage in biotech industry.”

Some key takeaways offered by Dr. Chi include:

  • Taiwanese firms are involved in both the production of conventional “small molecule” pharmaceuticals as well as the development of cutting edge “large molecule” biological drugs derived from cells
  • Taiwan’s biotech firms include Taimed, Medigen, TaiGen, TopoGenomics, TTY Biopharma and many others with a combined market cap of US$23 billion
  • Taiwan currently has 96 drugs in the development pipeline, over half of them in Stage 2 clinical trials
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Dr. Chi Wei-kuang presents the Taiwan biotech industry’s “Diamond Action Plan” to AmCham Taipei leaders.

The newer field of Biological drugs is seen as offering highest value with lower capital investment and operating costs, where key areas for drug development include oncology, central nervous system (CNS) disease, infectious disease, and inflammation and autoimmune diseases.

Since the early 1980s Taiwan’s government has been offering support to the biotech industry through a number of policies and organizations, but major funding for the industry only occurred over the last 5-6 years.

Key policies to watch for the Taiwan Biotech Industry:

  • Statute for the Development of Biotech New Drug Industry
  • Biotech Industry Takeoff Action Plan
  • Diamond Action Plan for Biotech Takeoff

Key organizations involved in the industry’s advancement

  • Development Center for Biotechnology (DCB)
  • Taiwan Food and Drug Administration (TFDA)
  • Biomedical Engineering Research Center (ITRI)

Funded by the Ministry of Economic Affairs, Taiwan’s DCB offers support bridging the gap between primary research and drug commercialization. The National Research Program for Biopharmaceuticals will expire in 2016, but will be replaced by the BioEconomy Plan.

Taiwanese biotech firms, though small, are highly innovative and are actively collaborating with foreign firms for advanced clinical trials and drug development. Continued government support is vital for the industry to fulfill its vision.

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AmCham Taipei Vice Chairwoman Libby Driscoll (left) and Chairman Dan Silver (right) present Chi Wei-kuang with a token of appreciation following his presentation.

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