Research and Development
Regulatory Issues
Regulation is necessary to ensure, as far as possible, the efficacy, safety and quality of new medicines. But the cost of meeting regulatory requirements is rising in developing countries which affects the cost of, and incentives for, research and development. Developing countries face a challenge in establishing effective regulatory regimes which meet their specific circumstances.
Documents
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Innovation and Stagnation: Challenge and Opportunity on the Critical Path to New Medical Technologies | FDA | 2004| [pdf 245kb]
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The globalization of regulatory requirements and the development and availability of medicinal products in developing countries: Quality, efficacy and safety issues | P. Trouiller et al | Médecin Sans Frontière | 1 March 2002
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Legal and Regulatory Issues Affecting Drug Development for Registration of Pharmaceuticals for Human Use | By P. Trouiller et al | DNDi |2001
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100 Years of biologics regulation | FDA Consumer Magazine | July-August 2002
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Effective Drug Regulation: What countries can do? | World Health Organization | 1999
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Summary breakout discussion group: regulatory capacities and challenges | P. Folb
Other resources
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Vaccines: Victims of Their Own Success? Why the most effective public health intervention evokes a mixed response from the public | By Ricki Lewis | The Scientist | 19 July 2004
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Rotavirus vaccines (Correspondence) | By D. Narula, L. Tiwari, J.M. Puliyel | Lancet | 16 July 2004
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Asia's Tigers get the blues | By Carina Dennis | Nature Vol 429 | 17 June 2004