Consultation

Introduction
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The CDE’s consultation services are available to the biotech companies, pharmaceutical companies, non-government organization and research institutes registered in Taiwan. Foreign companies or academic research institutes seeking the CDE’s consultation services should send their requests through any of the aforementioned eligible agencies in Taiwan.

  • General Regulatory consultation Services

    In order to improve the quality of clinical trials and to support the R&D activities in Taiwan, the CDE provides regulatory consultation services for the bio-pharmaceutical industry and research institutes throughout the development process of drugs and medical devices. The regulatory consultation services aim to enhance the industry’s R&D capability and competitiveness. The services are available through direct telephone inquiries or online submission of inquiry forms. Inquires can be made according to R&D schedule, case properties or regulatory requirements. Upon the receipt of a service inquiry, the CDE 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.
    The CDE also provides consultation services on Health Technology Assessment (HTA). The CDE offers opportunities to drug companies and medical device companies to seek advices and to clarify questions concerning the applications for NHI listing and pricing. The HTA consultation services can be delivered in written form or via face-to-face meetings.

  • Consultation Services on Cases under Review

    The CDE provides consultation services on cases currently under the review process so as to strengthen the communication with applicants. The administrative reviewer will serve as the contact person. Applicants may contact the administrative reviewer in charge of their cases for any questions concerning deficiency submissions. Questions raised will be forwarded to technical reviewers for a written reply. If deemed necessary, a teleconference or a face-to-face meeting can be arranged.

  • Consultation services on Index Case

    The CDE has started to provide consultation services on Index Case since 2005. A dedicated consultation team is available to provide regulatory advices for bio-pharmaceutical companies and academic research institutes in order to guide them through the R&D process, phase-by-phase. The consultation team adopts an active and involved approach and sets out to help the industry reduce R&D costs and expedite the R&D process.