Good Clinical Practice Principles: Legal Background and Applicability

Since 1991 the European Medicines Agency (EMA, formerly EMEA) adopted the Guidelines of the International Conference onHarmonization (ICH) onGoodClinical Practice (GCP). In this regard, one European Union (EU) Guideline and three EU Directives are in force at present, that is, the E6/CPMP/ICH/135/95 GCP Guideline, Directive 2001/83/EC (Community Codex on Pharmaceuticals), Directive 2001/20/ EC (GCP and Clinical Trials, CTs), and Directive 2005/28/EC (Detailed Guidance on GCP). European Directive 2001/20 on GCP and CTs has been widely criticized by a large portion of the scientific community more directly involved in the promotion and management of noncommercial academic CTs. Since 2003 several scientists from academia highlighted through the international scientific literature the difficulties inherent in the new EU regulation, in particular as regards GCP compliance and quality monitoring problems. Such difficulties have also been acknowledged by Directive 2005/28 where, among others, it is stated that for academic CTs the application of certainGCP aspects may be unnecessary or guaranteed by othermeans. None of these documents oblige CTs to be in compliance with the GCP ICH Guideline (GCP-ICH) full text and details. Rather, they prescribe that CTs be in compliance only with GCP principles and with GCP Guidelines laid down in Directive 2005/28 EC, this being less binding when compared to the GCP-ICH Guideline.At the national level, EUMember States (MS) adopted different legislation to implement the GCP obligations. MS GCP Inspectorates generally act as if all GCP aspects were mandatory to verify the reliability of data reported by the CTs audited. At the international level, in particular in developing countries, where several bioequivalence (BE) studies are conducted and the number of CTs is increasing, often