Regulatory and HTA framework for herbal medicines in Indonesia

Abstract

Background: Herbal medicines are widely used in Indonesia and other LMICs, yet their integration into national health systems relies on coherent regulatory oversight, reliable evidence generation, functional pharmacovigilance (PV), and alignment with health technology assessment (HTA) and financing processes. Existing evidence varies in rigour and maturity, creating uncertainty for regulators and policymakers. A consolidated understanding of how available evidence informs regulatory, HTA, PV, and financing decisions is needed to guide a more predictable, evidence-informed governance framework for herbal medicines in Indonesia. Methods: An integrative review was conducted using Scopus, PubMed, Google Scholar, WHO IRIS, the ASEAN TMHS repository, and national regulatory portals for literature published between 2015 and 2025. Thirty-seven studies met eligibility and WHO-based methodological quality criteria. Data were extracted using a structured matrix, synthesised thematically, and deductively mapped to five analytic domains: evidence generation, regulatory pathways, HTA processes, pharmacovigilance systems, and financing-governance alignment. Results: Three system-level themes emerged. First, substantial misalignment exists between available evidence and regulatory requirements, driven by heterogeneous clinical methods, limited comparator data, and variable standardisation. Second, HTA remains weakly integrated into decision-making due to gaps in clinical effectiveness, limited economic evidence, and challenges in assessing multi-component interventions. Third, PV and governance systems show fragmentation, weak inter-agency coordination, and inadequate safety signal detection. These interdependent weaknesses reduce regulatory predictability, constrain HTA feasibility, and limit informed financing decisions. Conclusion: This review provides the first integrated synthesis of evidence generation, regulatory pathways, HTA processes, PV systems, and financing-governance alignment for herbal medicines in Indonesia. Findings highlight the need to strengthen evidence standards, adapt HTA methodologies, reinforce PV and laboratory capacity, and improve regulatory-financing linkages. Implementing the proposed framework can enhance policy coherence, regulatory transparency, and safety oversight, supporting more credible and evidence-informed integration of herbal medicines into Indonesia's health system.

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