Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

The Effects of the 12th Amendment to the German Pharmaceuticals Act on Clinical Trials in Academic Institutions and the Pharmaceutical Industry ***

Dr. Andrea Klüting (Abschlußjahr: 2005)

Language: German

With the passing on 30 June 2004 of the 12th amendment to the German Pharmaceuticals Act, European norms relating to the field of clinical trials were transfered into national law.

This has led to far-reaching changes in all areas of clinical trials. One of the most significant changes is the introduction at the supreme federal office of an approval process that replaces the former notification procedure.

The prime ethics committees approval procedure has also been reorganised.

The new definition of clinical trials now also includes therapy optimizing studies as well as Investigator Initiated Trials (ITT). As a consequence, these types of studies now have to conform to GMP and GCP standards.

The sponsor of a clinical trial is responsible for the management of the whole study, and also carries responsibility for civil and product liability. This raises questions about the potential extent of his liability especially against the background of stricter pharmacovigilance requirements.

An opinion poll was carried out in the pharmaceutical industry and in academic institutions nine months on in order to reveal any problems in the handling of the new legislation. The results show that the pharmaceutical industry has had predominantly satisfactory dealings with the competent authority. The latter has been praised for its efficiency and cooperativeness, even though the time limits given by law are currently being used to the full. An acceleration of the process is desirable in order to remain competitive on a European level.

Furthermore, there is a trend emerging where applications are no longer dealt with exclusively in the realm of clinical research, but are increasingly involving Regulatory Affairs as well.

The academic institutions, on the other hand, resent the high administrative costs and believe non-commercial clinical research to be very much under threat. Here, a framework needs to be developed to unburden doctor-researchers. Centers for the coordination of clinical trials can be part of this process, as can seizing all opportunities for the future that Directive 2005/28/EC offers.

Pages: 56, Annexes: 11