Guidance on Index Case

The Executive Yuan unveiled the “Taiwan Biotech Take-off Diamond Action Plan” to boost the research and development capability for medical product commercialization.  In light of this strategic plan, the CDE provides advices on regulatory requirements which should be considered by all new drug developers in their R&D processes.  In the past 15 years, the CDE has built up its capacity for regulatory science from performing technical dossier review on applications of new drugs and clinical trials.   The CDE is now applying this valuable knowledge to strengthening the basis for drug translational researches so as to open up new opportunities for product commercialization.   This consultation service will provide the solid foundation for the biotech industry and increase the industry’s international competitiveness. The CDE has been providing regulatory advices on the development of medicinal products on a phase-by-phase basis for the bio-pharmaceutical industry and academic researcher institutes in Taiwan since the mechanism of consultation services on Index Case was set up in 2005.   For each Index Case, a dedicated consultation team is formed to provide consultation services in an active and involved manner with a view to reducing R&D costs and expediting the R&D process.

The CDE assesses the application of Index Case upon the receipt of each application. The selection criteria are: innovation, contribution to public health, maturity of the case and regulatory requirements. A formal contract shall be signed between the CDE and the successful applicant. The consultation team and the applicant shall jointly decide the annual target and the goals for each phase.   The consultation team will arrange meetings, monitor the progress and provide comprehensive regulatory consultation services and international regulatory references in every phase of the R&D process.  The CDE believes the consultation team’s active and involved approach will fulfill the goals of reducing R&D costs and expediting the R&D process.