As of the 1st May 2004, the New Medicines for Human Use (Clinical Trials) regulations 2004 became law, implementing the EU Clinical Trials Directive 2001/20/EC of the European Parliament.
Below is an extract from the directive. To view the full directive click Here (PDF document)
The main aim of the directive is to simplify and harmonise the administrative provisions governing clinical trials by establishing a clear, transparent procedure and creating conditions conducive to the effective co-ordination of such clinical trials in the European community by the authorities concerned.
The directive covers the conduct within the EU of clinical trials on medicinal products involving human subjects whether sponsored by industry, Government, research organisations, charity or university.
The directive sets standards for:
Most of the procedures and criteria are already part of current UK clinical trials practice. However, when the Directive is fully implemented it will affect clinical research of medicinal products in the following areas:
The term sponsor is defined as "an individual, company, institution or organisation, which takes responsibility for the initiation, management and/or financing of a clinical trial.
Sponsor may delegate all or part of the trial related functions, but they retain ultimate responsibility for ensuring that the conduct of the the trial and the final data generated comply with Directive 2001/20/EC. It is stated that the sponsor and the investigator can be the same person.
The EU Directive is divided into 7 chapters and 33 articles:
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