Policy Evaluation for Regulating Toxic Traditional Chinese Medicines in Taiwan

Abstract: 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. Plain Language Summary: In recent years, researchers and regulatory bodies have increasingly focused on the safety of traditional Chinese medicine (TCM), responding to recurrent reports of poisoning and adverse reactions caused by improper usage. To improve the safe administration of TCM, this study conducts a comprehensive evaluation of existing regulatory frameworks. We investigate the governance of toxic Chinese medicinal substances in Taiwan by examining documented poisoning incidents and analyzing current regulatory policies in comparison with international standards and practices. Our analysis identifies systemic deficiencies in the Taiwan Pharmacopoeia and related regulations, particularly in toxicity classification, processing methods (Paozhi), dosage safety, and adverse reaction reporting mechanisms. We advocate for a science-based regulatory approach that applies toxicological principles and risk assessment methodologies. We recommend establishing rational usage restrictions and standardized toxicity classifications to ensure the safe and effective use of toxic Chinese herbs. Keywords: adverse reaction reporting, processing, paozhi, risk assessment, safe dosage