Introduction

The main aim of the Clinical Trials Directive 2001/20/EC 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.1

The Directive will be interpreted and transposed into national legislation by each individual Member State for implementation on 1 May 2004. The UK's statutory instrument has now been approved and published. Please click on the link below:
http://www.legislation.hmso.gov.uk/si/si2004/20041031.htm

Information contained in this document has been sourced from the Medicines and Healthcare products Regulatory Agency (MHRA), as the primary source of advice on the Directive in the UK. Richmond Pharmacology is fully prepared for and will confidently comply with all proposed UK regulations.

The new EU Directive addresses a number of key areas in the conduct of clinical trials:

1. Provides a statutory basis for ethics committees.
2. Provides a statutory basis for Good Clinical Practice (GCP).
3. Introduces regulation in the conduct of clinical trials in healthy volunteers (Phase I trials).
4. Introduces requirements for good manufacturing practices (GMP) in the manufacture of investigational medicinal products (IMPs).
5. Introduces responsibilities for sponsors and investigators in adverse drug reaction (ADR)/adverse drug event (ADE) reporting.

This document summarises the key potential implications for Richmond Pharmacology and how this affects sponsor companies, it is not an exhaustive list of the Directive's requirements. Further information on the full scope of the legislation can be obtained directly from MHRA (please see below).

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