# Evidence-based production framework for herbal medicine regulation in Indonesia

## TL;DR

This paper proposes a framework for regulating herbal medicine production in Indonesia using scientific evidence and modern technologies to ensure quality and consistency.

## Contribution

The novel contribution is a proposed evidence-based production framework integrating omics, QbD, and regulatory harmonization for herbal medicine in Indonesia.

## Key findings

- Advanced production technologies like in vitro root culture and bioreactors improve supply consistency.
- Omics tools such as DNA barcoding and metabolomics enhance authentication and chemical reproducibility.
- ASEAN/WHO initiatives support regulatory harmonization while preserving traditional diversity.

## 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.

Graphical abstract with four segments: “Evidence-Based Production” showing a flask with a plant, “OMICS QbD” with a gear and checkmark, “Harmonization” featuring scales with a globe and document, and “Healthcare Integration” displaying a shield with a leaf. Arrows connect each section.