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Harmonization of Ethics Policies in Pediatric Research

Published online by Cambridge University Press:  01 January 2021

Valarie Blake ,
Steve Joffe  and
Eric Kodish
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Extract

The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have launched a recent initiative to enhance collaboration in research, with the intent to “ensure that clinical trials submitted in drug marketing applications in the United States and European Union are conducted uniformly, appropriately, and ethically.” This initiative recalls efforts from two decades ago when the United States, the European Union and Japan formed the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) as a mechanism for harmonizing clinical research regulations. The intent of harmonization was to improve patients’ “access to new drugs, to prevent unnecessary global development delays and to avoid animal and human study duplications” through policy reconciliation.

FDA/EMA efforts at collaboration call for a reassessment of past harmonization efforts: to what extent are ICH member policies already synchronized and to what extent can they be harmonized in the future? This paper will focus on these questions through the lens of pediatric investigation.

Type
Independent
Information
Journal of Law, Medicine & Ethics , Volume 39 , Issue 1 , Spring 2011 , pp. 70 - 78
Copyright
Copyright © American Society of Law, Medicine and Ethics 2011

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