• Last updated：2025-07-22
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Since its establishment in 1998, the CDE has been an important partner for the government in improving the health and welfare of the people nationwide. The CDE, with its professional review team, assists the competent authority in gatekeeping various innovative biotech pharmaceutical products, medical devices, medical techniques, and health technology assessments. While ensuring safety and effectiveness, it also increases the public’s accessibility to various emerging treatments.

The CDE is committed to “regulatory science, protecting life and health”, cultivating independent review capabilities, and aligning with international standards. It assists the competent authority, enabling Taiwan to be among the first in the world to approve various types of drugs. The review capacity and quality are equivalent to those of advanced countries. We possess extensive expertise in regulatory science and review, offering comprehensive consultation services to academia and industry, aiming to enhance submission quality and accelerate the innovative development of the biotech industry.

The CDE will continue to uphold regulatory science, cooperate to promote the innovative development of the biotech industry, assist the government in gatekeeping the effectiveness and safety of various biotech products, and enter clinical use, in order to improve the health and welfare of the people nationwide.