BACKGROUND:
Regulatory systems are a critical yet often under-recognized component of public health governance. Decisions on the authorization, regulation, and post-market oversight of health products are shaped by political determinants such as legislation, institutional capacity, and global regulatory collaboration. Weak or fragmented regulatory governance can undermine access to quality-assured medicines, exacerbate inequities, and erode public trust. As countries transition into a post-SDG era, effective regulatory affairs functions are increasingly recognized as essential for resilient and accountable health systems.

OBJECTIVES:
This study examines regulatory affairs as a political determinant of public health, exploring how regulatory governance and global collaboration mechanisms influence health system performance, equity, and access to safe and effective medical products.

METHODS:
A qualitative health systems and regulatory governance analysis was conducted, drawing on multi-country regulatory practice in pharmaceutical product registration, lifecycle management, post-market surveillance, and regulatory reliance. Regulatory frameworks, policy documents, and operational experiences involving national and regional regulatory authorities were reviewed to assess governance structures and decision-making processes.

RESULTS:
The analysis shows that strong regulatory governance improves health system performance by supporting timely access, product quality, and market stability. Regulatory reliance, harmonized standards, and international collaboration reduce duplication and accelerate approvals. In contrast, weak legal frameworks, limited autonomy, and politicized decision-making contribute to delayed access and the circulation of substandard and falsified products.

CONCLUSIONS:
Regulatory systems function as a core political determinant of public health by shaping accountability, access, and trust within health systems. Strengthening regulatory affairs is therefore both a technical and governance priority in the post-SDG context.

RECOMMENDATIONS:
Policymakers should integrate regulatory systems strengthening into broader health governance reforms through investment in regulatory capacity, protection of regulatory independence, institutionalization of regulatory reliance, and stronger global and regional collaboration mechanisms.