EDITOR'S DESK

New EU Regulation Set To Drive Clinical Trial Harmonization

Sponsor companies conducting clinical trials in the European Union (EU) are currently regulated by EU Directive 2001/20/EC, which provides guidance on clinical trial applications and conduct. Unfortunately, Directives always have to be transposed into National law. By transposing, different countries interpret Directives in slightly different ways. Every country has its own national legislation, resulting in different submission requirements, timelines, classifications, and safety reporting. The result of this lack of harmonization is a complicated and expensive trial process. 

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