藥品管理與一般消費品管理不同，其攸關民眾身心健康及生命安全，先進國家將之列為高度管制產業，食品藥物管理署 (Taiwan Food and Administration, TFDA) 在保障國人健康前提之下，以生命週期管理方式，從上市前藥品研發、臨床前試驗、臨床試驗、審查至上市後的藥品品質安全監控，同時提供民眾溝通宣導及藥事服務。回顧103年臺灣藥品政策重點管理成果，包含建置再生醫學產品管理環境，健全透明、效率、多元及現代化藥品審查體系，建構藥品安全及品質之天羅地網，積極參與國際藥政合作，臨床試驗查核制度轉型，提升特殊族群正確用藥知能等。並於今年 (104年) 延續103 年度的藥品管理政策，推行更加完善藥政新措施，以接軌國際邁向全球的藥政管理為目標，強化再生醫學產品管理，建置審查電子送件機制，逐步推動藥品優良審查規範及藥品優良送件規範，精進藥品上市後管理，持續進行多元化藥事服務，逐步落實藥品原料藥管理及藥品賦形劑標示管理政策，以期提升全民福祉。
 

Different from consumer goods, medicinal products are highly regulated in advanced countries. In order to ensure public health, Taiwan Food and Administration (TFDA) has established a product lifecycle management system, which includes pre-marketing basic research, preclinical studies, clinical trials,registration, and post-marketing surveillance. In addition, consumer communication, advocacy and pharmacist care services are also provided. Review the achievements of Taiwan pharmaceutical policy management in 2014, we have established regenerative medicine regulatory environment, improved the transparent, efficient,multiple and modernized drug review and approval mechanisms, actively participated in international pharmaceutical affair collaboration, reformed the policy of good clinical practice inspection, advanced the knowledge for using drugs in special groups, etc. This year, TFDA will continue the medicinal product management policies and promote more faultless pharmaceutical policy. TFDA aims to connect and follow the policy of international pharmaceutical management, including enhancement of regenerative medicine regulation, establishment of a review e-submission system, implementation of Good Review Practice (GRevP) and Good Submission Practice (GSP), empowerment of medicinal product post-marketing management, and enforce of multiple pharmacist care services. TFDA will progressively strengthen the management of active pharmaceutical ingredient (API) and excipient labeling regulations to increase the public welfare in Taiwan.