Evidence-based production framework for herbal medicine regulation in Indonesia

Area of Science:

• Herbal medicine production
• Pharmacognosy
• Regulatory science

Background:

• Herbal medicine production faces challenges in consistency and supply variability.
• Advanced technologies and omics offer solutions for quality control and authentication.
• Regulatory harmonization is crucial for global acceptance of herbal medicines.

Purpose of the Study:

• To review evidence-based production (EBP) of herbal medicines from 2015-2025.
• To explore advanced production technologies, omics-enabled authentication, quality by design (QbD), and regulatory harmonization.
• To propose a framework for Indonesia's regulatory agency (BPOM) to operationalize EBP.

Main Methods:

• Narrative review of scientific literature (2015-2025).
• Analysis of advanced production technologies (in vitro culture, bioreactors, nanotechnology).
• Evaluation of omics approaches (DNA barcoding, metabolomics) and QbD principles.
• Assessment of regulatory harmonization initiatives (ASEAN, WHO).

Main Results:

• Advanced technologies improve herbal medicine consistency and address supply variability.
• Omics approaches ensure identity and chemical reproducibility.
• Regulatory initiatives facilitate harmonization while respecting traditional diversity.
• A two-key batch-release specification (genomic x metabolite) is proposed.

Conclusions:

• Implementing EBP requires integrating advanced technologies, omics, and QbD.
• A validated omics workflow under Good Laboratory Practice (GLP) is essential for traceability.
• An actionable framework can position Indonesia as a regional hub for evidence-based herbal regulation.
• Digital pharmacovigilance and real-world evidence enhance post-market safety monitoring.