Role & Function

　　　The principal functions of CDE are: to help Bureau of Pharmaceutical Affairs to set up the review system and enhance the ability to review new drug applications, to support DOH to establish a mechanism in drafting guidelines, and to provide consultation service to local bio-pharmaceutical industries, to upgrade Taiwan’s ability to review the new drug applications of products developed domestically and those have not been approved in any other advanced countries. CDE is a non-governmental and non-profit organization, communication with worldwide regulatory agencies through active participation in international convention is necessary. In order to keep path with current trends, CDE fascinates DOH to communicate and exchange experiences with international experts. In addition, other major functions of CDE include introduction of Taiwan’s progress to international communities and further strengthen international cooperation.

　　　In recent years, through the development of biotechnology, the related research has been enthusiastically conducted. Our government devotes many resources and efforts to upgrading the pharmaceutical industry and the development of biotechnology. Gene therapy, stem cell therapy, and recombinant DNA technique that have been focused worldwide, have become a challenge for us. Because of these reasons, CDE began to plan and set up procedures to review biotechnology techniques and products. In the era of global trading, the goal of the development of biotechnology is to target global marketing, The development of biotechnology, in addition to the local guidelines, as well as the quality, efficacy and, safety, has to meet the international standard.

　　　Chinese medicine is a very important resource in Taiwan. Because of thousands of years’ of clinical experiences and vast documents, Taiwan has leading edge compared to other nations in conducting research of Chinese medicine. However, its value is difficult to be recognized internationally due to lacking of well-designed experiments and scientific data. Like other industry, Chinese medicine industry must have sufficient large market, in order to survive. If Taiwan intends to develop the Chinese medicine industry, “globalization” is the choice and no other alternative can be substituted. In order to enhance the competitivenes of domestic Chinese medicine industries, CDE cooperates with the Chinese Herbal Medicine Committee to establish a modernized mechanism in reviewing clinical trial protocols and new Chinese medicine registration. CDE aims to build up an innovative technology platform through integration of regulations and successful marketing experiences regarding Chinese medicine development worldwide. CDE provides consultation to sponsors in line with the rapid growth of Chinese medicine worldwide. The present government’s goal is to promote Taiwan as a major research center for Chinese medicine.

The Structure of Department of Health (DOH)