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Emerging challenges and opportunities in drug registration and regulation in developing countries

HILL, Suzanne
JOHNSON, Kent
May 2004

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This study describes current drug regulation and registration processes in selected countries, in order to understand how they affect the quality and availability of medicines in developing countries. It puts forward policy recommendations as to how systems can more efficiently allow appropriate quality drugs to be marketed and examines the emerging challenges and requirements posed by compulsory licensing, drugs for neglected diseases, anti-retroviral (ARV) and anti-tuberculosis (TB) drugs

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