Regulatory System Models for Small States/Markets with Limited Resources. Concept Note and Recommendations. Ninth Conference of the Pan American Network for Drug Regulatory Harmonization (PANDRH). (San Salvador, 24 to 26 October, 2018)

Abstract

[Extract]. Regulatory systems are an essential part of well-functioning health systems and critical to the achievement of universal access to health and universal health coverage. Therefore, there is increasing focus on strengthening medical product regulatory systems around the world, which has been the priority of the Pan American Network for Drug Regulatory Harmonization (PANDRH). The Pan American Health Organization/World Health Organization (PAHO/WHO), as PANDRH’s Secretariat, has drafted this concept note to help Member States with limited resources develop approaches to strengthen regulatory systems to assure safe, quality, and effective medicines for people in the Americas... The aim of this document is to spotlight the regulatory challenges faced by small states with limited resources, especially in light of mandates to strengthen regulatory systems in the Americas and globally, and to ensure all peoples have access to quality medicines through the implementation of certain essential regulatory functions. It offers theoretical and practical advice about the adoption of key efficiencies to strengthen small state regulatory systems. It is also a call to action for PANDRH stakeholders, including governments, industry, and donors, to strengthen small state regulatory systems in the future.