• Last updated：2024-08-16
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Who we are
Entrusted by the Ministry of Health and Welfare's Taiwan Food and Drug Administration (TFDA), the Center for Drug Evaluation, Taiwan, is responsible for assisting with the technical dossier evaluation of drug applications before and after the drugs are marketed and helping the competent authorities develop regulatory science-related tasks. Additionally, leveraging extensive knowledge of regulatory science and years of review experience, we provide regulatory consultation services for each stage of drug research and development to marketing for R&D units and industry players.
Regarding the drug evaluation team, we recruit professionals in fields such as medical and health, biochemistry, and biotechnology, including physicians, pharmacists, and masters and doctoral degree holders in various fields such as clinical, statistical, pharmacotoxicology (Pharm/Tox), chemistry manufacturing control (CMC), biologics (BIO), pharmacokinetics/pharmacodynamics (PK/PD), and project management (PM). These professionals collaborate to conduct technical dossier evaluations and administrative regulatory reviews as well as provide regulatory consultation services to ensure the effectiveness, safety, and quality of drugs.

 
What we do
(I) The evaluation of drug applications