| Harmonization, regulation, and trade: interactions in the pharmaceutical field. | |
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MedLine Citation:
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PMID: 15560428 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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This article aims to draw attention to the process of harmonization of requirements for drug registration (the so-called ICH process) and to examine how it may affect access to medicines in developing countries. The ICH process, especially when seen in conjunction with the World Trade Organization's Agreement on Technical Barriers to Trade, may create additional barriers to would-be entrants on the global pharmaceutical market, notably large generic manufacturers in developing countries-the very companies that can create credible price competition for the innovative industry and, thus, increase access to medicines. These barriers could help maintain the status quo by insulating well-established companies from competition, thereby forming a further obstacle to lower drug prices and to access to medicines, especially in developing countries. Developing countries should therefore carefully consider the implications of the positioning of ICH standards as global standards, and be vigilant with regard to their possible incorporation, whether explicitly or not, in international trade agreements. |
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Authors:
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Karin Timmermans |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: International journal of health services : planning, administration, evaluation Volume: 34 ISSN: 0020-7314 ISO Abbreviation: Int J Health Serv Publication Date: 2004 |
Date Detail:
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Created Date: 2004-11-24 Completed Date: 2005-02-03 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 1305035 Medline TA: Int J Health Serv Country: United States |
Other Details:
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Languages: eng Pagination: 651-61 Citation Subset: IM |
Affiliation:
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World Health Organization, Jakarta, Indonesia. timmermansk@who.or.id |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Commerce
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organization & administration* Developing Countries Drug Industry / organization & administration* Drug and Narcotic Control / organization & administration* Drugs, Generic / supply & distribution Health Services Accessibility Humans International Cooperation* Reference Standards |
| Chemical | |
Reg. No./Substance:
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0/Drugs, Generic |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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