uems-logo esicm-logo

EBICM

European Board of Intensive Care Medicine

Clinical Trial - Directive

The Clinical Trials Directive aims to establish “specific provisions regarding the conduct of clinical trials, including multi-centre trials, on human subjects involving medicinal products as defined in Article 1 of Directive 65/65/EEC, in particular relating to the implementation of good clinical practice.”  (art.1) It provides rules about protection of clinical trial subject, with a particular attention to minors and incapacitated adults, and, sets up an Ethics Committee, charged of providing its opinion before the start of a clinical trial.
Before beginning a clinical trial the sponsor is asked to submit a request for authorization to the competent authority of the Member State in which the sponsor plans to conduct the clinical trial.

The Commission's health directorate – which was handed control over the pharmaceutical policy in 2010 – describes the directive as "arguably the most criticised piece of legislation" the EU has ever produced on medicines.

Two solutions are possible at this stage, clarifying the existing directive or creating a totally new one, in order to have a better legislation that could be implemented by Member States in a less heterogeneous way, and to generally have more efficient rules for the scientific community dealing with them.
Commission has issued a road map. of its impact assessment, setting out the main structure and the next steps.

Update 03 March 2011

On 9 February 2011, a public consultation on a concept paper on the revision of the 'Clinical Trials Directive' 2001/20/EC has been launched. The concept paper presents:
a 'preliminary appraisal' of which option appears to be the most suitable one to address some of the key concerns of the Clinical Trials Directive, on the basis of the current state of the impact assessment; and the main figures that are being used to evaluate the impacts of the different policy options.
The Commission has scheduled adoption of the legislative proposal for 2012 (Commission Work Programme 2011)

Update 18 July 2011

The Clinical Trials Directive aims to establish “specific provisions regarding the conduct of clinical trials, including multi-centre trials, on human subjects involving medicinal products as defined in Article 1 of Directive 65/65/EEC, in particular relating to the implementation of good clinical practice.” (art.1).

It provides rules about protection of clinical trial subject, with a particular attention to minors and incapacitated adults, and, sets up an Ethics Committee, charged of providing its opinion before the start of a clinical trial.
Before beginning a clinical trial the sponsor is asked to submit a request for authorization to the competent authority of the Member State in which the sponsor plans to conduct the clinical trial.

The Commission's health directorate – which was handed control over the pharmaceutical policy in 2010 – describes the directive as "arguably the most criticised piece of legislation" the EU has ever produced on medicines.

On 9 February 2011, a public consultation on a concept paper on the revision of the 'Clinical Trials Directive' 2001/20/EC was launched. The concept paper presented:
a 'preliminary appraisal' of which option appears to be the most suitable one to address some of the key concerns of the Clinical Trials Directive, on the basis of the current state of the impact assessment; and the main figures that are being used to evaluate the impacts of the different policy options.

On 23 June 2011, Responses to the Public consultation on the concept paper on the Revision of the 'Clinical Trials Directive' 2001/20/EC were published and on 7 July 2011, the summary of responses was released.

Next steps

The new legislation about clinical trial will be adopted in 2012 The Commission has scheduled adoption of the legislative proposal for 2012 (Commission Work Programme 2011)

 

Purple Spider Web Design