Purpose

This independent blog collects news about projects or achievements in regulatory reform / better regulation. It is edited by Charles H. Montin. All opinions expressed are given on a personal basis.
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04 May 2010

Clinical trial directive under fire

In addition to yesterday's post on recent SANCO BR activity, another of the major pieces of EU legislation on pharmaceuticals is in the line of fire: the clinical trials directive, described as "arguably the most criticised piece of legislation" the EU has ever produced on medicines", and other unflattering comments. This legal act was listed among those in scope of the Commission's Action Programme for reducing administrative burdens, but no proposal for simplification has yet been put forward. This may be about to change. See clinical trial page on Europa for reference to consultation results and roadmap of reform, and excellent Euractiv dossier of today.

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