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

Therapeutic Innovation & Regulatory Science
Yauba SaiduAnne Marie Georges

Abstract

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 be used to set up an integrated regional licensing system, a system that will provide for a single product dossier application and a single review, leading to a single approval that will grant access to all the markets in the re...Continue Reading

References

Aug 9, 2007·PLoS Medicine·Michael J BrennanUNKNOWN Developing Countries Vaccine Regulatory Network and the Ad Hoc Regulatory and TB Expert Panel
Sep 7, 2007·The New England Journal of Medicine·Peter J HotezLorenzo Savioli
Feb 4, 2009·Nature Reviews. Drug Discovery·Paul L Herrling
May 22, 2010·Lancet·Stefan H E KaufmannPaul-Henri Lambert
Nov 27, 2010·Clinical Trials : Journal of the Society for Clinical Trials·Thomas J BollykyErnst Berndt
Oct 20, 2011·The New England Journal of Medicine·UNKNOWN RTS,S Clinical Trials PartnershipPreeti Vansadia

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Citations

Dec 14, 2018·Therapeutic Innovation & Regulatory Science·Lawrence LibertiHubert Leufkens

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