Regulatory and Accreditation Systems and Their Association With Health Workforce and Healthcare Quality in Low- and Middle-Income Countries: A Systematic Review and Policy Analysis.

Purpose: To synthesize evidence on the association between regulatory and accreditation systems and health workforce and healthcare quality in low- and middle-income countries (LMICs), and to analyze the policy factors that shape their implementation. Methods: A systematic review reported according to PRISMA 2020. PubMed, Scopus, Web of Science and Google Scholar were searched for English-language literature published between January 2010 and March 2026. Eligible sources examined regulatory or accreditation mechanisms in at least one LMIC and were analyzed as three separate evidence streams: primary empirical studies, evidence syntheses, and policy or programme analyses. Quality was appraised with design-specific tools (CASP, Newcastle-Ottawa Scale, QuADS, AMSTAR 2 and AACODS). Evidence was synthesized narratively using thematic synthesis, and a literature-based policy analysis applied Walt and Gilson's Policy Triangle. Responsive Regulation Theory and Institutional Theory were used as interpretive lenses. Results: Of 1,243 records, 35 sources met the inclusion criteria (21 primary studies, 7 evidence syntheses and 7 policy or programme analyses). Sources came from the Middle East and North Africa (n = 12, of which 7 were from Iran), sub-Saharan Africa (n = 6), East and South Asia (n = 4) and Latin America (n = 1), with 12 multi-country sources. Thirty-two sources concerned accreditation of health facilities; only two addressed medical education accreditation and one addressed regulation of individual health professionals. Evidence was concentrated at the level of institutional processes (24 sources), where accreditation was associated with standardized procedures, documentation, internal quality assurance and governance structures. Few sources measured workforce-level outcomes (n = 3), and associations with clinical quality were mixed: the two primary impact evaluations reported divergent results. Recurrent barriers included inadequate financing, assessor shortages, fragmented governance, weak enforcement and documentation burden. Conclusion: The available evidence suggests that regulatory and accreditation systems in LMICs are associated with improvements in institutional quality processes, particularly when supportive follow-up accompanies graduated requirements. Evidence that they improve health workforce competence or patient outcomes remains limited. Controlled evaluations of licensing, continuing professional development and education accreditation in LMICs are needed.