Concept Paper on the Revision of the GCP Directive published
The European Commission has published a Concept Paper on the revision of the contents of the GCP Directive. Directives are binding and must be transposed into national law of the Member States. Yet, small modifications are allowed. For example, the GCP Directive was implemented into the German Medicines Legislation in 2004 in the 12th German Drug Law (12. AMG-Novelle) and a respective Guidance.
In the meantime, experiences made by the Member States have been discussed in workshops by the European Commission and the European Medicines Agency EMA. The results of these workshops have shown that the contents of the directive as well as the transposition in the respective national legislation might need a partial revision.
Based on two public consultation procedures carried out between October 2009 and January 2010, the European Commission has now compiled different subjects which need to be revised. The different proposals will be detailed in the present Concept Paper and assessment is awaited:
An identical request could be submitted for studies in the different Member States. For example, a common EU portal could be set up. Afterwards, a common assessment procedure could be carried out, comparable to the Marketing Authorisations for Drugs (Coordinated Assessment Procedure, CAP).
Changes within the scope, especially regarding non-interventional studies. More exceptions should be allowed, like studies from academic and non-commercial sponsors. However, there would be a need for further harmonisation.
Contents of the approval application for clinical studies as well as the reporting on the safety of the investigational medicinal products must be specified and based on risk-management concepts.
A clearer definition of investigational medicinal products and additional indications for the treatment with auxiliary medicinal products during clinical studies must be provided.
Optimisations in the field of insurance and indemnity.
A clearer definition of the sponsors and the introduction of possible co-sponsoring or multiple sponsors roles in clinical studies
Emergency clinical trials: for this, some adaptations incl. patients' declaration of consent in emergency cases are required.
A separate chapter focuses on ensuring compliance with Good Clinical Practice for clinical studies in third countries.
ll the concerned expert groups are invited to give their comments and remarks on the Concept Paper, especially on the 18 questions to the European Commission until 13 May 2011.
Wolfgang Schmitt CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)