The Challenge of Globalization in Pharmaceutical Law: Is an International Drug Approval System Modeled after the European System Worth Considering?
Title: The Challenge of Globalization in Pharmaceutical Law: Is an International Drug Approval System Modeled after the European System Worth Considering?
Author: PURNHAGEN, Kai Peter
Citation: Food and Drug Law Journal, 2008, 63, 3, 623-645
Pharmaceutical Companies are highly globalized. This widening of drug markets leads to an erosion of the national government‘s legislative powers. With trials and marketing of compounds and pharmaceuticals carried out in different countries, ensuring safety and effectiveness of drugs becomes increasingly problematic. Thus, international pharmaceutical approval harmonization as well as drug monitoring, belongs paramount. One way of solving this problem might be to model an international pharmaceutical authorization system on the European Decentralized Procedure with involvement of the International Conferences of Harmonisation. That’s the focus of this article.
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