Consultation Services For Drugs

        In light of the government’s policy to promote the biotech industry and to create the industry’s competitive edge, the CDE undertakes a mission to provide the bio-pharmaceutical industry and academic research institutes in Taiwan the most comprehensive regulatory consultation services on drug development (including new drugs, generic drugs, botanical new drugs, bio-pharmaceuticals and emerging biotech products for cell or gene therapy). The services cover from early phase R&D planning to the commercialization of a new product. The CDE hopes the consultation service helps accelerate new drug development and create more success stories.

A regulatory consultation mechanism which meets the industry’s expectation has come into operation under the CDE.  With this mechanism in place, the CDE is able to satisfy the industry’s demand for regulatory science, facilitate the communication between the regulatory agency and the industry, increase the industry’s R&D capacity and create an environment conducive to the future development of the pharmaceutical industry.  The scope of the CDE’s drug advisory services include: (1) Consultation Services on Cases under Review; (2) General Regulatory consultationAdvisory Services; and (3) Consultation services on Index Case.

Applicants can make inquiries according to R&D schedule, case properties or regulatory requirements.  The CDE’s consultation services are available through direct telephone inquiries, online submission of inquiry forms and applications for Index Case.  Upon the receipt of an inquiry, the CDE will form a consultation team based on the nature of the inquiry.  The consultation team will conduct a thorough analysis of the issues raised by the applicant, and provide feasible solutions and suggestions on regulatory pathways to remove any regulatory obstacles to product development.