FDA Actively Promotes the “Industrial Consultation and Guidance for Regulatory Science on Drugs and Medical Devices”



Since the establishment of Food and Drug Administration (FDA), Department of Health on January 1, 2010, the Executive Yuan has been dedicated to strengthening medical and pharmaceutical industrial guidance through the promotion of the “Diamond Action Plan for Biotech Takeoff”. A consultation/guidance mechanism and diamond early harvest list for drug and medical device projects are developed for the domestic research and development of new drugs and medical devices.

The project consultation and guidance mechanism for drugs includes 4 evaluation criteria – “innovativeness”, “contribution”, “early harvest” and “fulfillment of regulations”; for medical devices, items are selected based on the 4 evaluation criteria of “first of its kind in domestically produced items”, “the best among same-category products”, “new medical indication” or “industry under focal support of a national project”. The mechanism sets its goals based on the milestones of assisting the projects in reaching the pre-clinical to clinical test stage (first in human), entering the next clinical test, applying for inspection and registration, and obtaining the license.

Since the establishment of FDA, 10 products in the drug area have been guided successfully to reach the R&D milestone, with 2 items having completed the marketing application, 5 items entering the third-stage clinical test, 1 item entering the second-stage clinical test, and 2 items entering the first-stage clinical test. In terms of medical devices, the achievements include 10 items having completed marketing, and 3 items having completed the clinical test application.

In addition, FDA has also convened the initial meeting of manufacturer consultation and guidance for at least 8 projects. Through face-to-face communication with the manufacturers, FDA has understood the R&D plan and status, and proposed specific and helpful suggestions to accelerate the inspection and marketing processes for new drugs and new medical devices, so that Taiwan people may use our self-developed new products as early as possible.