Introduction

Time flies, and the Center has entered its ninth year .Past six years, with the increasing volume of our business, the Center has seen substantial growth in its personnel and office space. In spite of stressful environmental changes associated with office relocation, our colleagues continued to do their best in reviewing clinical trial protocols for investigational new drugs and evaluating new drug applications, in drafting guidelines, and in helping to promote the pharmaceutical industry. Building on to our early experiences, we have established standards and mechanisms for the evaluation of new drugs to safeguard public safety in drug usage, and provided consultation services to the industry on regulatory requirements to facilitate the research and development of new drugs.

It has not been an easy journey, but, it is gratifying for me to see the Center grow steadily. One of Center’s principal tasks is to review the new drug applications, which requires the participation and expertise of many full-time faculty members in different specialty fields. In keeping with the government’s efforts in promoting the research and development of the biotechnology industry, and the advancement in new technologies in the bio-pharmaceutical industry, we have recruited various experts into CDE,

for example, Medical Doctors in different specialty fields (including physicians in traditional Chinese medicine and physicians with other advanced degrees such as J.D. or Ph.D.), as well as scientists with a Master's or a Ph.D. degree in statistics, chemistry, pharmacology, and other related fields. In addition to carefully recruiting professional members, we have also paid attention to important matters of training and passing of experiences. Furthermore, in order to keep up with the international standards in regulatory requirements, we have actively participated in various international events and communicated with the regulatory agencies in advanced nations. Through conferences and visits, we have introduced reforms in policies and laws by the Pharmaceutical Administration and the related achievements in Taiwan to other nations in the world, established good models for interactions, and provided timely assistance to the Department of Health in the drafting and updating of related guidelines and regulations.

At the present, reviewers at CDE are capable of reviewing the new drugs that are not yet approved for marketing in any countries in the world, and are also devoting their efforts to the promotion and improvement in gene therapy and clinical trial environment. However, in order to meet the challenge of the changing big environment we not only have to maintain the present competitiveness, but also to enhance the professional capability in reviewing to gradually keep up with the international standards. In the future, CDE will be actively in providing various evaluation and consultation services based on a professional review and service system with the best quality, high efficiency, transparence and consistency. Ultimately, CDE would like to improve and perfect our country’s regulatory environment to move toward internationalization.