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. In many developing countries, where the need of these products is greatest, the national regulatory authorities often lack the resources and regulatory capacity to review the registration dossiers to approve the use of new products. Given this challenge, new regulatory models are urgently needed to offset product registration. In this paper, we propose how regional regulatory frameworks established by regional harmonization initiatives can b...