Product Registration in Developing Countries: A Proposal for an Integrated Regional Licensing System Among Countries in Regional Economic Blocs.

The product pipeline for diseases that disproportionately affect the developing world has considerably expanded over the last decade. Indeed, there are about 134 products for these diseases in the pipeline, including vaccines, drugs, diagnostics, microbicides, and vector control tools, and dozens of these products are currently being evaluated in human trials in developing countries where the disease of interest exists. While these efforts are underway, the need to identify regulatory pathways for licensing these new products is becoming obvious to many manufacturers.

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.