REVIEW article
Front. Pharmacol.
Sec. Ethnopharmacology
Evidence-Based Production Framework for Herbal Medicine Regulation in Indonesia
Provisionally accepted
- 1Faculty of Pharmacy, University of Indonesia, Depok, Indonesia
- 2Badan Pengawas Obat dan Makanan, Jakarta, Indonesia
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This narrative review synthesizes 2015–2025 evidence on evidence-based production (EBP) of herbal medicines with emphasis on advanced production technologies, omics-enabled authentication, quality by design (QbD), and regulatory harmonization relevant to Indonesia. We map how in vitro root culture, bioreactor scale-up, elicitation/metabolic engineering, and nanotechnology address supply variability and improve consistency; how DNA barcoding/metabarcoding and metabolomics with chemometrics underpin identity and chemical reproducibility; and how ASEAN/WHO initiatives enable 'loose harmonization' while preserving traditional diversity. We argue for a two-key batch-release specification (genomic × metabolite) and validated omics workflows within GLP to strengthen traceability, with real-world evidence and digital pharmacovigilance extending safety monitoring post-market. We translate these elements into an actionable framework for the Indonesian FDA (BPOM) to operationalize EBP through regulation, cross-sector training, and reliance pathways, positioning Indonesia as a regional hub for evidence-based herbal regulation.
Keywords: ASEAN harmonization, Evidence-based production, herbal medicine regulation, omics authentication, Pharmacovigilance, Quality by design, Regulatory Science
Received: 28 Oct 2025; Accepted: 03 Dec 2025.
Copyright: © 2025 Kashuri, Ikrar, Sutriyo, Munim and Yanuar. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Mohamad Kashuri
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.