1st May, 2001, saw the final publication of the long-anticipated European Union Directive relating to Good clinical practice in the conduct of clinical trials on medicinal products for human use (2001/20/EC). The Directive consolidates, for the first time, aspects relating to the manufacture and provision of clinical material, clinical trial regulatory approval, and the protection of trial subjects, which encompass the conduct of clinical trials in the European Union. There are certain aspects of the directive which sow the seed of change within the pharmaceutical industry. For the first time, a qualified person will be required to perform the release of the investigational medicinal product (IMP) for use in a clinical trial. Good manufacturing practice in the manufacture of IMPs will be a legal requirement universally across the EU. This was previously dependent on member states instituting controls voluntarily. There are also changes in the pre-approval process for some biopharmaceutical products prior to trial commencement. In this paper we will explore the contents of the Directive and consider how this will impact the biopharmaceutical industry.
A sponsor's experience with the Voluntary Harmonization Procedure for clinical trial applications in the European Union
