GCP-Inspektionen in Deutschland und Europa nach Implementierung der Direktive 2001/20/EG
Teil 1: Regulatorisches Umfeld
Dr. Claus Göbel1, Dr. Dieter Baier2, Dr. Heiner Gertzen3, Dr. Birgit Ruhfus4, Per-Holger Sanden5, Dr. Jürgen-Hans Schmidt6 und Dr. Dorette Schrag-Floß7 Pfizer Pharma GmbH1, Karlsruhe, Roche Pharma AG2, Grenzach-Wyhlen, Sanofi-Aventis Pharma S. A.3, Paris (Frankreich),
Bayer Schering Pharma AG4, Berlin, Merck Serono International SA5, Darmstadt, Sanofi-Aventis Pharma Deutschland6,
Bad Soden, CSL Behring GmbH7, Marburg
Korrespondenz: Dr. med. Claus Göbel, Klinische Forschung, Pfizer Pharma GmbH, Postfach 49 49, 76032 Karlsruhe (Germany),
Fax 0721 6203 305, e-mail: claus.goebel@pfizer.com
The implementation of the Clinical Trials Directive 2001/20/EC and the Good Clinical Practice Directive 2005/28/EC fundamentally restructured and harmonized the conduct of clinical trials in Europe. GCP inspections – which affect study sites, laboratories, sponsors and contract research organizations (CROs) alike – make up an important part of the regulations laid down in these directives. The following paper presents an overview of the international and national regulatory requirements for GCP inspections with special regard to GCP inspections at sponsor sites. The overview was put together by a working group of the Clinical Research/Quality Assurance subcommittee of the German Association of Research-Based Pharmaceutical Companies (VFA, Verband Forschender Arzneimittelhersteller e.V., Berlin).In the two next issues of this journal two further publications are forthcoming:
they will present the results of a survey among VFA members on GCP inspections that took place between 2005 and 2007, and provide guidance for accompanying GCP inspections at sponsor sites.The publication of the procedures for conducting GCP inspections by the GCP Inspectors Working Group (in the context of the centralized procedure) and the publication of procedures on inspections for clinical trials of medicinal products by the German Central Authority of the Laender for Health Protection with Regard to Medicinal Products and Medical Devices (ZLG, Zentralstelle der Länder für Gesundheitsschutz
bei Arzneimitteln und Medizinprodukten) have helped increase transparency and harmonization. Ongoing dialogue between the competent authorities and the sponsors about the interpretation of the fundamental regulatory requirements with regard to GCP would be desirable to work towards the common goal of continuously improving the quality of clinical research. |
