Abstract
Taiwan’s Critical Path Program facilitates the development process for niche products of new drug and medical devices. The program fosters a favorable regulatory environment by establishing guidance systems and identifying selected index cases for successful stories through achievement-based proactive consultation. A total of 27 index cases were selected from a total of 68 cases submitted. Two index cases have been terminated due to poor results. Five index cases have been ended with milestones achieved. In 2008, 21 index cases were actively in operation. Nine of them have advanced from the preclinical stage to the clinical stage. The proactive consultation mechanism, rolling review, impact on funding mechanisms, milestone achievement, and customer satisfaction feedback of this program are described in this article.
Published Version
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