Clinical trials, German drug law, GCP-V and implementation into practice

The European Directive 2001/20/EC for the implementation of good clinical practice (GCP) in the conduct of clinical trials on medicinal products for human use was entered into force on 4 April 2001.

The EU member states were obliged to adopt and publish before 1 May 2003 the laws, regulations and administrative provisions and to apply these provisions at the latest with effect from 1 May 2004.

In Germany the Directive was implemented by the 12^th novel of the German Drug Law (6 August 2004) and the GCP-V (14 August 2004).

Some of the new requirements are for example that the sponsor has to receive the approval of the ethics committee and the competent authority (e.g. BfArM), the suitability of the investigators and the quality of the facilities have to be assessed and the EudraCT number for the study protocol has to be obtained from the EMEA database before starting a clinical trial.

The consequences of the new regulations will be discussed on the background that these regulations are valid for all clinical trials – regardless, if the sponsor is an academic site or the pharmaceutical industry.