EU Clinical Trials Directive 2001/20/EC

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:

• Protecting clinical trial subjects
• The manufacture, import and labelling of investigational medicinal products (IMPs)
• Good Manufacturing Practice (GMP)
• Good Clinical Practice (GCP)

Implications for Clinical Trials conducted in the UK

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:

• There will be specific timescales for ethical review
• Phase I clinical pharmacology studies on healthy volunteers will need approval
• Investigational medicinal products (IMPs) only to be manufactured at licensed manufacturing sites under conditions of Good Manufacturing Practice (GMP)
• Introduction of inspections to assess compliance with good manufacturing practice (GMP) and good clinical practice (GCP)

Implications for the Role of Sponsor

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.

Headings of Draft Directive

The EU Directive is divided into 7 chapters and 33 articles:

• Scope
• Good Clinical Practice for the design, conduct and reporting of Clinical Trials on human subjects involving medicinal products
• Manufacturing or import authorization
• Documentation constituting the Trial Master File and archiving
• Qualifications of Inspectors
• Inspection Procedures
• Final provisions

Trial Documentation - Investigator Brochure

• Shall be presented in a concise, simple, objective balanced and non promotional from that enables a clinical or potential investigator to understand it and make an unbiased risk -benefit assessment of the appropriateness of the proposed trial.
• Should be updated annually
• Summary of product characteristics to replace the Investigator brochure if the Investigational Medicinal Product has a marketing authorisation.