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"Regulatory interdependence in a global economy: The globalization of pharmaceutical regulation in the EU and internationally"

Vogel, David. (1997) "Regulatory interdependence in a global economy: The globalization of pharmaceutical regulation in the EU and internationally". In: UNSPECIFIED, Seattle, WA. (Unpublished)

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    Historically drug regulation has been virtually synonymous with national sovereignty. Over the last decade, this has begun to change: national regulatory agencies are more closely cooperating with one another. The European Union has established a centralized drug approval system; the United States Food and Drug Administration has begun to accept foreign clinical data; and a number of industrial nations have made substantial progress toward standardizing their regulatory procedures and requirements. This paper describes and assesses the implications of recent developments in the international coordination of national drug approval policies. It specifically examines the emergence of a single market for pharmaceutical products in the European Union, the globalization of American drug approval policies, and the accomplishments of a new international body, the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceutical Products.

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    Item Type: Conference or Workshop Item (UNSPECIFIED)
    Uncontrolled Keywords: Pharmaceutical industry.
    Subjects for non-EU documents: EU policies and themes > External relations > EU-US
    EU policies and themes > Policies & related activities > public health policy (including global activities)
    EU policies and themes > External relations > globalisation/globalization
    Subjects for EU documents: UNSPECIFIED
    EU Series and Periodicals: UNSPECIFIED
    EU Annual Reports: UNSPECIFIED
    Conference: European Union Studies Association (EUSA) > Biennial Conference > 1997 (5th), May 29-June 1, 1997
    Depositing User: Phil Wilkin
    Official EU Document: No
    Language: English
    Date Deposited: 15 Mar 2007
    Page Range: p. 31
    Last Modified: 15 Feb 2011 17:23

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