Draft on New GCP Directive 2001/20/EG

The GCP Directive 2001/20/EG is currently revised. Now, the EU Commission has submitted a draft. At the same time, two so-called Impact Assessment Reports have been published. The first document describes potential consequences on the existing procedures and the institutions involved. The second one explains the consequences on possible costs due to the conduction of clinical trials in Europe. A Question & Answer document on the topic has been published. But that's not enough, additional summaries have been created which describe the necessity of the procedure: one for the circles of experts concerned and another one for citizens.

In the documents, the European Commission presents three essential objectives of the revision of the current legislation:

1. Modernisation and improvement of the regulatory framework regarding the submission and evaluation of applications for approval of clinical trials. Especially for multinational clinical trials, the administrative burden and costs should be reduced. Also delays for starting clinical trials should be avoided.

For this, an authorisation procedure should be instaured to consider only one submission of the dossier - which requires a common assessment by the Member States. The same procedures (and not different requirements from divergent national implementation arrangements) should be followed by all Member States throughout the EU. The Ethics Committee's action remains unaffected by this.

2. The legal requirements regarding yearly security reports of clinical trials and the obligatory insurance must be adapted to the practical considerations.

For this, obligatory insurance should be refrained. Instead, a risk-based assessment should be performed and allow to cover damages with already existing insurances (mainly for clinical trials with marketed medicinal products) instead of contracting an extra patient insurance. At the same time, Member States would be under an obligation to set up a national indemnification mechanism which ensures compensation for clinical trials performed (should damages occur).

3. Particularities of clinical trials performed internationally - ensuring compliance with the Good Clinical Practices should be better regulated.

In order to increase transparency, additional public registers - also in third countries - as well as inspections of the authorisation and monitoring systems in the fields of clinical trials in third countries shall be implemented. This also means the creation of a new monitoring system to control the respective systems in third countries. This system should be established by the EMA.

Source: Press release and Website of the EU Commission

Compiled by:
Wolfgang Schmitt
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)