# Evidence-based production framework for herbal medicine regulation in Indonesia
> Kashuri M.

URL kanonis: https://discover.unhas.ac.id/publications/pub_scopus_105027634517
Jurnal / Konferensi: Frontiers in Pharmacology
Tahun terbit: 2026
DOI: https://doi.org/10.3389/fphar.2025.1730273
ISSN: 16639812
Kuartil SJR: Q1
Citations: 9

## Authors
- Kashuri M.

## Abstract
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
- Harmonization
- Operationalization
- Workflow
- Pharmacovigilance
- Quality (philosophy)
- Production (economics)
- Business
- Indonesian
- Traceability
- Biotechnology
- Knowledge management
- Procurement
- Traditional medicine
- Medicine
- Process management
- Standardization
- Data science
- Risk analysis (engineering)
- Narrative review
- Quality by Design
- Counterfeit
- Digital health
- Computer science
- Resource (disambiguation)
- Translational research
- Counterfeit Drugs
- Chemometrics
- Product (mathematics)
- Custodians
- Automation
- Pharmacology
- Engineering

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Sumber: Discover Unhas — RIMS Universitas Hasanuddin.
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