A Review of Regulatory Mechanisms Used by the WHO, EU, and US to Facilitate Access to Quality Medicinal Products in Developing Countries With Constrained Regulatory Capacities

Adequate medicine regulation requires nations to establish robust regulatory agencies that will subject all pharmaceutical products to pre- and postmarketing evaluation. These agencies are essential for any country wishing to ensure that the medicinal products it authorizes for use in its territory meet internationally agreed standards of safety, quality, and efficacy. Many developing nations, however, lack regulatory systems that can guarantee this set of requirements. As a result, almost all of these nations tend to rely on regulatory decisions made by well-resourced institutions, particularly the US Food and Drug Administration, the European Medicines Agency, and the World Health Organization. In this paper, the authors review the objectives, strengths, and weaknesses of some key regulatory initiatives instituted by these bodies to facilitate product registration in developing countries with constrained regulatory capacities.