The Critical Path Program in Taiwan
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Bing Bing Lin, PhD, EMBA Principal Researcher. Center for Drug Evaluation, Taipei, Taiwan: Adjunct Assistant Professor. Department of Business Administration and Department of Healthcare Management, Chang Gung Universify, Tao Yuan, Taiwan Chih-hwo Lin, PhD Director. Division of Resource Development, Center for Drug Evaluation, Taivei. Taiwan Horny-Der Chern, MD, PhD Executive Director. Center for Drug Evaluation, Taipei, Taiwan
Key Words Critical Path Initiatives: Drug development: Proactive regulatory consultation mechanism; Rolling review: Customer satisfaction
Correspondence Address Dr. Bing Bing Lin. Center for Drug Evaluation. 1F. No. 15- I , Sec. I , Hangjou S. Rd.. Taipei 100, Taiwan (email: a332199 @gmail.com).
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The Critical Path Program in Taiwan 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 identifing selected index cases for successfil stories through achievement-based proactive consultation. A total of 27 index cases were selectedfiom a total of 68 cases submitted. Two index cases have
IN T R O D UCTlO N The FDA’s Critical Path Initiative (l),launched in March 2004, is designed to stimulate a national effort to modernize the science through which FDA-regulated products are developed, evaluated, and manufactured. Critical Path research is directed toward improving the product development process by establishing new evaluation tools. The Critical Path Program increased the industry-regulatory agency interaction during drug development, as shown in Figure 1 (1). Following the spirit of the US FDA Critical Path Initiative, Taiwan’s Critical Path Program was launched by Taiwan’s Center for Drug Evaluation (CDE) in 2006, with an annual budget of US $1.8 million. The Department of Health (DOH) contracted the project to the CDE as part of a four-year national project to establish Taiwan as a Biomedical Technology Island by proactively supporting the development of selected promising index cases through regulatory consultation and the promotion of research and development (R&D) for new drugs and devices in Taiwan.
BACKGROUND Drug development is a global business, and yet is an expensive one with high risk. Regulatory agencies play an important role in the drug development process. They are responsible for safeguarding the welfare of clinical trial subjects and patients and must be efficient and transparent in the process. Many regulatory
been terminated h e 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 j h m the preclinical stage to the clinical stage. l%eprOact*ve consultation mechanism, rolling review, impact on finding mechanisms, milestone achievement, and customer satisfaction feedback of this program are described in this article.
agencies in Asian countries have made tremendous progress in this regard (2). An example is the es
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