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dc.contributor.advisorHutt, Peter Bartonen_US
dc.contributor.authorHochberg, Ellen A.en_US
dc.date.accessioned2012-06-07T20:41:29Z
dc.date.issued2002en_US
dc.identifier.citationTHE NEED FOR COMPREHENSIVENESS AND INCREASED ENFORCEABILITY IN THE STANDARDIZATION OF INTERNATIONAL PHARMACEUTICAL REGULATIONS (2002 Third Year Paper)en
dc.identifier.urihttp://nrs.harvard.edu/urn-3:HUL.InstRepos:8852191
dc.description.abstractThis 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.isoen_USen
dash.licenseLAAen_US
dc.subjectFood and Drug Lawen
dc.subjectstandardizationen
dc.subjectinternational standardizationen
dc.subjectregulationen
dc.titleTHE NEED FOR COMPREHENSIVENESS AND INCREASED ENFORCEABILITY IN THE STANDARDIZATION OF INTERNATIONAL PHARMACEUTICAL REGULATIONSen
dc.typePaper (for course/seminar/workshop)en_US
dc.date.available2012-06-07T20:41:29Z
dash.authorsorderedfalse


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