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![]() Driving innovation through competition.About GenericsOverviewThe Science of Generic MedicinesOverviewAffordability & Sustainable HealthOverviewIntellectual PropertyOverviewFurther ResourcesBibliography Books & Articles Reports & Studies Internet Resources |
Further ResourcesBooks & Articles
Reports & Studies7 May 2002 G10 Medicines - Final Report: Recommendations for Action• High Level Group on Innovation & Provision of Medicines. Published by the European Commission, Brussels 24 October 2001 Budgetary challenges posed by ageing populations: the impact on public spending on pensions, health and long-term care for the elderly and possible indicators of the long-term sustainability of public finances• Economic Policy Committee (EPC). Published by the European Commission, Brussels (EPC/ECFIN/630-EN final) November 2000 Evaluation of the operation of Community procedures for the authorisation of medicinal products• Evaluation carried out on behalf of the European Commission by CMS Cameron McKenna and Andersen Consulting. November 2000 Global Competitiveness in Pharmaceuticals: A European Perspective• Pammolli, Fabio et al. Report Prepared for DG Enterprise, European Commission. February 1999 Policy Relating to Generic Medicines in the OECD• NERA - National Economic Research Associates. Study carried out on behalf of the European Commission. July 1998 How Increased Competition from Generic Drugs has Affected Prices and Returns in the Pharmaceutical Industry• CBO—US Congressional Budget Office. The Hatch-Waxman Act of 1984 established an abbreviated approval process for generic medicines and extended patents for originator drugs in the United States, setting an important legislative precedent for the world. Has Hatch-Waxman increased competition from generic drugs? How has it affected profits in the originator industry? Internet Resources
CDER - Office of Generic Drugs
The US Center for Drug Evaluation and Research's Web site on generic medicines and marketing authorisation in the United States. EudraLex: Rules Governing Medicinal Products in the EUA complete listing and on-line archive of EU pharmaceutical legislation, organised in nine “volumes”. EudraVigilance: Pharmacovigilance in the EUOfficial information on pharmacovigilance activities related to medicinal products authorised in the European Economic Area (EEA). Public Citizen - Health Research GroupA great deal of information about medicines oriented to protecting the interests of consumers and patients is available on this US Web site.
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