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Biomaterial One-Stop-Shop Website

In order to provide comprehensive services for the biotech industry, to facilitate the customs clearance of imported raw materials used in biomedical researches or manufacturing, to promote the development of the biotech industry and to achieve the target of improving the global competitiveness of the biotech industry in Taiwan, the Biomedical Industry Innovation Program (BIIP) Implementation Center has worked together with relevant government agencies and jointly established the “Biomaterial One-Stop Service Window”. This system uses interactive web pages to provide the information of the classification of biomaterials, the customs clearance processes and the contact details of relevant competent agencies in charge. The “one-stop window” helps to expedite the customs clearance process so that imported biomaterials can be used more effectively before their expiration.

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Rising Star - Taiwan New Drug

Rising Star - Taiwan New Drug Many new drugs developed by our members have already entered the global markets. For example, Onivyder® developed by PharmaEngine has been launched in 34 countries; Taigexyn® developed by TaiGen has secured the marketing authorization in China; Trogarzo® developed by TaiMed Biologics has been approved by the US FDA; and, last but not least, Besremi® developed by Pharma Essentia has been approved by the EMA in the EU and is ready for its global launch. As of in February 2019, the drug developers in Taiwan have commissioned a total of 295 clinical trials conducted in Taiwan and other countries, including 171 trials in the US. In addition to Taiwan and the US, our members are keen to entering the markets in the EU, China, South Korea, Japan, Australia, Canada, Russia, South Africa, etc. Operating from their bases in Taiwan, our members are shining as important players in the global markets.

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Overview of R&D of Taiwan’s Regenerative Medicine Industries (in Chinese))

Overview of R&D of Taiwan’s Regenerative Medicine Industries and the Anticipation of “ Regenerative Medicinal Products Derivatives Act”

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「生技醫藥產業發展條例」修法及配套措施建議研究報告

「生技新藥產業發展條例」將於2021年底落日，未來之「生技醫藥產業發展條例」勾勒我國下一個十年生醫產業發展前景，四大生醫領域產業肯定行政院版擴大適用範圍，亦支持研發及製造並重的策略方向。產業建議適用範圍之定義應符合科技及產業發展趨勢；研發及人才培訓支出應維持原條例35%抵減率，並取消連續五年獲利之要求，增列市場開發人才之認定；放寬個人股東投資抵減門檻，並延長生醫公司設立年限之認定。與此同時，產業呼籲建置「國藥國用、新興科技管理法規、友善投資環境、多元募資管道」的基礎配套刻不容緩，且為我國生技醫藥產業及「生技醫藥產業發展條例」成功之關鍵。生技醫藥產業為我國核心經濟產業，也為國家安全產業，本研究集結所有生醫產業共識，提出「生技醫藥產業發展條例」修法及基礎配套建議，資金、技術、人才、法規、市場缺一不可，期望立法院、行政院各部會及全國各界同體一心高瞻遠矚，正面、積極、創新、支持我國生技醫藥產業邁向下一個十年，為國家、民眾創造更高福祉，經濟奇蹟！

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