Book Reviews

2001/20/EC – A European Directive?

Major Regulatory Objectives for a Real Harmonisation in Europe

Barbara Römer. Tectum Verlag, Marburg (2009). ISBN 978-3-8288-2056-2. 186 pages, paperback. Price: 荤 24.90.

The formation of the European economic area has led to a demand for the harmonisation of trade relations in general. For pharmaceutical products the procedures to obtain a marketing authorisation are widely developed within the European scope. But with regard to clinical trials – being a prerequisite for marketing authorisation – there are still differences complicating especially multi-center trials with investigations in more than one country. Despite of the Clinical Trials Directive different (national) procedures must be followed. This is one of the main statements in the present paperback, a master thesis.

At first, the clinical trial authorisation procedures of ten European countries are described in brief: Austria, Belgium, Czech Republic, Germany, Italy, Poland, Slovenia, Spain, The Netherlands, and United Kingdom. This is followed by a “situation appraisal” of topics of non-harmonisation and “objectives for improvement”. The final conclusion is that today Member States of the European Union are far away from a transparent, time-saving and harmonised clinical trial authorisation procedure and that measures should be taken to solve this situation as soon as possible.

The paperback is a call for respective legislative actions directed to the European Union as well as to the Member States. Additionally, it is a valuable help for companies concerned with today’s situation. Descriptions of national peculiarities help to prepare clinical trial applications, to plan the course of trials and thereby to prevent delay of the product development process.

(ECV)