Quality and contaminant governance in herbal products: regulatory and industrial control models in Indonesia and Taiwan
Purpose 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.
Authors
- Yithro Serang (ORCID: https://orcid.org/0000-0002-3956-0932)
- Wei‐Jyun Chien (ORCID: https://orcid.org/0000-0003-2618-8470)
Institutions
- Chaoyang University of Technology (TW)
- American Association of Colleges of Pharmacy (US)
Publication Details
- Journal
- British Food Journal
- Published
- 2026-10-28
- DOI
- https://doi.org/10.1108/bfj-03-2026-0449
- Primary Topic
- Pharmaceutical Quality and Counterfeiting
- Type
- article
- Field-Weighted Citation Impact
- 0.00