New clinical trials directive: Does this affect the way you produce pre-clinical and clinical material?

The European Directive on Good Clinical Practice in Clinical Trials (Directive 200½0/EC) will be implemented in the UK in May 2004. It covers many issues regarding the design and conduct of clinical studies and patient safety and lays down standards for the manufacture, import and labelling of investigational medicinal products (IMPs). It also requires, for the first time, that all clinical trial supplies be manufactured, tested, stored and packaged to GMP in licensed facilities and that they must be released by a Qualified Person before use. The Directive does not, at this time, cover the manufacture of Active Pharmaceutical Ingredients (APIs) although it is anticipated that the Directive's scope of coverage will likely be expanded in the future to cover the manufacture of investigational APIs. This article discusses the requirements of the Directive, the implications of these requirements, the potential expansion of the Directive to cover investigational API manufacture and finally the scope for contract service organisations to assist companies in complying with the Directive's requirements.