Taiwan

Taiwan is regulated by the Taiwan Food and Drug Administration (TFDA), an agency of the Ministry of Health and Welfare (MOHW), under the Pharmaceutical Affairs Act (藥事法) and the Regulations for Registration of Medicinal Products. Scientific review for new drugs (NDA/BLA) is conducted by the Center for Drug Evaluation (CDE), an independent non-profit established under MOHW. Taiwan is a full ICH member (since 2018), a PIC/S member (since 2013), and accepts CTD/eCTD dossiers. Taiwan operates a well-developed reliance and work-sharing framework: the TFDA–PMDA New Drug Review Scheme (since 2018) supports parallel review with Japan, and the Generic Drug Review Cooperation Scheme covers ANDAs. Local clinical bridging requirements have been substantially relaxed for products approved by reference regulators (US FDA, EMA, PMDA, Health Canada, MHRA, TGA) where ethnic-sensitivity is adequately addressed. Accelerated and priority review pathways exist for products meeting unmet medical need or severe/life-threatening condition criteria. Reimbursement is administered by the National Health Insurance Administration (NHIA) under Taiwan's single-payer National Health Insurance scheme. NHIA listing decisions are advised by the Pharmaceutical Benefit and Reimbursement Scheme (PBRS) Joint Committee (formerly the Expert Advisory Meeting), with health technology assessment performed by CDE's HTA division and including international price referencing across 10 reference countries.