Policy Evaluation for Regulating Toxic Traditional Chinese Medicines in Taiwan.

In recent years, growing reports of poisoning and adverse reactions linked to the misuse of traditional Chinese medicine (TCM) have raised increasing concerns about its safety. This article begins with the case of aristolochic acid nephropathy and draws on international regulatory practices to evaluate Taiwan's legal and policy framework governing toxic TCMs. The analysis reveals systemic deficiencies in the Taiwan Herbal Pharmacopoeia and related regulations, particularly in the classification of toxic substances, Paozhi (processing methods), and dosage safety standards. The article argues that the regulation of toxic TCMs should be grounded in scientific methodology and toxicological principles, incorporating risk assessment to establish rational toxicity classifications, standardized processing protocols, and usage restrictions, thereby enabling clinical practice to achieve the goal of high efficacy with low toxicity. It further advocates for the implementation of adverse event reporting mechanisms to safeguard public health.