Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

2001/20/EC - A European Directive? Major Regulatory Objectives for a real Harmonisation in Europe ***

Dr. Barbara Römer (Abschlußjahr: 2008)

Language: English

In 1997, the European Parliament and the Council of the European Union (EU) released the first draft of the EU Clinical Trials Directive. The document was finalised as Directive 2001/20/EC on 4 April 2001 and published in the “Official Journal of the European Communities” on 1 May 2001.
In the European Union a Directive is a type of legislation that is binding on the Member States (specific objectives are to be achieved within a certain time period) but allows the national government of each Member State to decide the form and means of implementation. Thus, all Member States of the EU were required to adopt and transpose the provisions of the Directive into national law by 1 May 2003. The Directive was implemented on 1 May 2004, and became legally binding on all parties involved in clinical research in human subjects. The transposition in local law started on 28 May 2003 in Denmark and ended on 24 March 2006 in Slovenia.

Main objective of the Directive 2001/20/EC was to simplify and harmonise the administrative provisions regarding clinical trials by establishing a clear procedure to avoid delays and complications linked to the multinational character of many clinical trials.

This master thesis analyses how far this objective was reached. The analysis focuses on the clinical trial authorisation procedure of Phase I to Phase IV clinical trials of medicinal products (clinical trials regarding gene therapy or somatic cell therapy or medicinal products containing genetically modified organisms were not considered in this evaluation).
Comparison of clinical trial authorisation procedures in 10 European countries revealed that the current procedures are far from a harmonisation in the Member States of the EU. Consequently start of clinical trials and thus launch of medicinal products is delayed and patients suffer from delayed availability of medicinal products. Therefore in near future revisions are necessary.

Short-, middle- and long-term measures are proposed in this master thesis in order to improve the harmonisation of the clinical trial authorisation procedures in the EU and finally to increase Europes attractiveness for clinical research and to ensure global (especially US) market competitiveness.

Pages: 118, 13 Annexes: pages: 39