Quality and contaminant governance in herbal products: regulatory and industrial control models in Indonesia and Taiwan
Wei-Jyun Chien, Yithro SerangPurpose
This study compares contaminant governance under Indonesia's Badan Pengawas Obat dan Makanan (Indonesian Food and Drug Authority) (BPOM)/Cara Pembuatan Obat Tradisional yang Baik (Good Manufacturing Practices for Traditional Medicines) (CPOTB) framework and Taiwan's Ministry of Health and Welfare (Taiwan)(MOHW)/Taiwan Food and Drug Administration (TFDA) pharmaceutical-integrated Traditional Chinese Medicine system. It examines how contaminant standards are translated into verification, supplier control, traceability and surveillance across regulatory and industrial stages.
Design/methodology/approach
A comparative regulatory analysis combined current regulations, pharmacopoeial standards, published surveillance studies and two anonymised organisational interview cases. A Regulatory-Industrial Coding Matrix covered four contaminant domains and a separate product-integrity domain. The Testing Frequency Risk Model classified routine, risk-based intensified, mandatory or continuous, and crisis-triggered verification.
Findings
Both jurisdictions regulate major contaminants, but their verification architectures differ. Indonesia relies more strongly on manufacturer-centred CPOTB controls, whereas Taiwan's formal system distributes selected verification across border, upstream, manufacturer and post-market stages. Plasticizer surveillance is also more institutionalised in Taiwan. These findings indicate differences in inferred governance capacity, not demonstrated regulatory effectiveness.
Practical implications
The framework supports risk-tiered supplier qualification, explicit testing-escalation rules, cross-stage information sharing and measurable implementation indicators.
Originality/value
The study develops a regulatory-industrial contaminant governance architecture in which verification localisation is a structural dimension, testing frequency is an operational mechanism and Contaminant Imagination Expansion explains adaptive changes in surveillance scope.