THE NEED FOR COMPREHENSIVENESS AND INCREASED ENFORCEABILITY IN THE STANDARDIZATION OF INTERNATIONAL PHARMACEUTICAL REGULATIONS

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THE NEED FOR COMPREHENSIVENESS AND INCREASED ENFORCEABILITY IN THE STANDARDIZATION OF INTERNATIONAL PHARMACEUTICAL REGULATIONS

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dc.contributor.advisor Hutt, Peter Barton en_US
dc.contributor.author Hochberg, Ellen A. en_US
dc.date.accessioned 2012-06-07T20:41:29Z
dc.date.issued 2002 en_US
dc.identifier.citation THE NEED FOR COMPREHENSIVENESS AND INCREASED ENFORCEABILITY IN THE STANDARDIZATION OF INTERNATIONAL PHARMACEUTICAL REGULATIONS (2002 Third Year Paper) en
dc.identifier.uri http://nrs.harvard.edu/urn-3:HUL.InstRepos:8852191
dc.description.abstract This article will discuss the main mechanisms by which the United States and other countries are attempting to standardize their pharmaceutical regulations. I first explore the need for standardization and the potential benefits that standardization offers. Then I sketch the early efforts of nations to move toward standardization. I present and critique the mechanisms by which standardization is currently proceeding and the progress that has been made to date. I also detail the Food and Drug Administration’s (FDA) participation in international standardization. I argue that reform of the standardization process is necessary to reap the full benefits of standardization. Specifically, the various tools of standardization, the ICH, MRAs, and MOUs need to be integrated so as not to work at cross-purposes. The standardization process must be expanded to account for the views of consumers and non-member nations. Most importantly, in the absence of a way to bind nations to commitments to standardize pharmaceutical regulations, standardization mechanism are in danger of becoming another layer of regulatory delay; to avoid this pitfall, standardization agreements must be made enforceable. en
dc.language.iso en_US en
dash.license LAA en_US
dc.subject Food and Drug Law en
dc.subject standardization en
dc.subject international standardization en
dc.subject regulation en
dc.title THE NEED FOR COMPREHENSIVENESS AND INCREASED ENFORCEABILITY IN THE STANDARDIZATION OF INTERNATIONAL PHARMACEUTICAL REGULATIONS en
dc.type Paper (for course/seminar/workshop) en_US
dc.date.available 2012-06-07T20:41:29Z

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