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Worldwide Harmonization of Pharmaceutical Authorization - A Guideline for an International Drug Approval System Modeled on European Law

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CONTRIBUTORS:
  Author Purnhagen, Kai P. (European University Institute)
UNIVERSITY / COLLEGE:
  University of Wisconsin-Madison Law School
YEAR: 2007
PUB TYPE: Thesis/Dissertation
PAGES: 8,  128 p.
SUBJECT(S): None
DISCIPLINE: Law
HTTP:
LANGUAGE: English
PUB ID: 103-445-661 (Last edited on 2008/10/09 07:54:18 GMT-6)
SPONSOR(S):
 
ABSTRACT:
Pharmaceutical Companies are becoming highly globalized. This widening of drug markets leads to an erosion of legislative powers of national governments. With trials and marketing of compounds and pharmaceuticals carried out in different countries, ensuring safety and effectiveness of drugs becomes increasingly problematic. Thus, international harmonization of pharmaceutical approval as well as monitoring of drugs belongs paramount. This can be done by modeling an international pharmaceutical authorization system on the European Decentralized Procedure with involvement of the International Conferences of Harmonisation.
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