By Emily Hayes BRUSSELS (Reuters Health) Oct 17 –
Proposed guidelines for a European Union directive governing clinical drug trials could trigger an avalanche of paperwork for the industry, increasing costs by up to 30% and driving drug companies out of EU member states, senior pharmaceutical industry figures have warned. The guidelines apply to the Directive on Implementing Good Clinical Practice, which was passed in 2001.
The directive aims to establish a single, harmonised legal framework for drug trials in EU member states. Member states are required to pass their own legislation, implementing the directive by May 2003.
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