Center for Drug Evaluation, Taiwan

The Center for Drug Evaluation was endowed by the Department of Health, the Ministry of Health and Welfare's predecessor, on 13 July 1998 to give the government a dedicated professional team to review new medicines. It reviews new drug applications and clinical trial protocols for the TFDA: in 2025 it completed 141 new drug applications, 38 of them antineoplastic or immunomodulating medicines, and 147 new clinical trial protocols outside the abridged route for multinational multicentre trials, 83 (56%) of them for cancer.

Its health technology assessment work began with a working group in August 2007, and its Division of Health Technology Assessment was formally set up on 1 April 2008. When the National Health Insurance Administration receives an application to list a medicine, the CDE accepts it within two days and completes its report within 42 days. An assessment is required for a new medicine that treats a catastrophic illness or has a new mechanism and is forecast to cost more than NT$100 million in any of its first five years, and for a widened indication forecast to cost more than NT$50 million a year. In 2025 it completed 58 assessments of breakthrough new medicines, 145 of other new medicines and 12 of special materials, and 89 reports were published on the insurer's site. It also reviews the reassessment plans required under the cancer medicine temporary payment rules of 25 February 2025. The division has grown to more than 60 people, and in May 2023 the insurer and the CDE signed a cooperation agreement with England's NICE.

The coordinates are a Taipei centroid, not the street address.