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.

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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
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article

Quality and contaminant governance in herbal products: regulatory and industrial control models in Indonesia and Taiwan

Yithro Serang, Wei‐Jyun Chien
5 links
British Food Journal
Pharmaceutical Quality and Counterfeiting
article

Quality and contaminant governance in herbal products: regulatory and industrial control models in Indonesia and Taiwan

Yithro Serang, Wei‐Jyun Chien
article en

Abstract

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.

British Food Journal
Chaoyang University of Technology (TW), American Association of Colleges of Pharmacy (US)
Peace, justice, and strong institutions, Good health and well-being
Openalex Percentile: Top 10%
Pharmaceutical Quality and Counterfeiting
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