Act for the Development of Biotech and Pharmaceutical Industry Article 14
To expedite the review and approval of new biotech and pharmaceutical products and facilitate product launch, each central competent authority in charge of the industry concerned shall establish open and transparent procedures and a unified review system for the necessary pre-market approvals, including field tests, clinical trials, product registration and others. Furthermore, these authorities shall develop professional review capabilities and refine the relevant review standards.To facilitate the R&D of biotech and pharmaceutical products and technologies, the Competent Authority and each central governmental authority in charge of the industry concerned may provide assistance in establishing testing sites for products and technologies under research and development.
中文原文 生技新藥產業發展條例第14條
為增進對生技醫藥產品之審核效能,促進產品上市,各中央目的事業主管機關對於生技醫藥產品上市前所需通過之田間試驗、臨床試驗、查驗登記等之審查,應訂定公開透明之流程及一元化審查制度,並應建立專業審查能量及精進相關審查規範。
為利生技醫藥產品及技術之研發,主管機關及各中央目的事業主管機關得輔導建立研發中產品及技術之試驗場域。
為利生技醫藥產品及技術之研發,主管機關及各中央目的事業主管機關得輔導建立研發中產品及技術之試驗場域。