Center for Drug Evaluation – An Introduction
Missions & Background
The Center for Drug Evaluation (CDE) was established by the Department of Health (now the Ministry of Health and Welfare, MOHW) on July 13th, 1998. The purpose of the CDE is to enhance the quality and efficiency of the evaluation of drugs and medical devices, further guaranteeing the public drug safety and increasing the public access to safe, effective and innovative drugs and medical devices.
Vision and Mission
The vision of the Center for Drug Evaluation is “Regulatory Science, Service for Life”. Our missions:
  1. The vision of the Center for Drug Evaluation is “Regulatory Science, Service for Life”. Our missions:
  2. In response to the country policy, develop regulatory environment, draft regulations and guidance that meet the international norms, and offer consulting services for industries so as to facilitate the development of new drugs and medical devices.
  3. Assist the Ministry of Health and Welfare to conduct health technology assessment (HTA) to promote reasonable usage of healthcare resources and enhance the public health.
  4. Promote international cooperation, becoming benchmark of regulatory science.
Since its establishment in 2006, the CDE has been providing quality services for various sectors of the industry, the academia, the government and the general public through a professional team with regulatory science expertise. The CDE aims to maximize the public health outcome based on balanced considerations of risk and benefit. As commissioned by the TFDA, the CDE performs various tasks, including implementing the Good Review Practice, enhancing quality management for the review of drugs and medical devices and assisting the TFDA in drafting regulations and guidance. Furthermore, the CDE plans to advance project-based services towards platform-based services by providing sponsors and research institutes with regulatory science advisory services in the early phases of the development of innovative drugs and medical devices. The CDE’s HTA team works closely with the NHIA to perfect the health care system in Taiwan. The CDE maintains professional connections with other regulatory agencies in major countries so as to facilitate the exchanges of experiences and information of regulatory science. With all these efforts, the CDE continues to be an instrumental partner of the TFDA and the NHIA in protecting the public health in Taiwan.