Clinical Trials Directive

We are now approaching the 'run up' phase to implementation of the Clinical Trials Directive (2001/20), which is due to be transposed into member states' national legislation by 30 April 2003 with full implementation by the corresponding date in 2004.

Thus far there has been little indication as to the practical aspects of the issuing of manufacturers' licences for the production of investigational medicinal products, and although the revision to annex 13 of the European GMP guidelines has been through several drafts, there remain a number of major uncertainties.

One concern revolves around the qualifications and scope of the responsibilities of the Qualified Person (QP) in relation to the quality systems covering the manufacture and release of investigational medicinal products.

The 'grandfather' clause allowing those who may not have the formal qualifications to be a QP under the medicines legislation but have carried out the release role for CT materials in the past is to be welcomed. However, some peripheral questions are as yet unanswered – such as those relating to experience of QPs who have carried out the traditional activities of a such a role in normal manufacture but may not have done so in a CT role. There are also questions about the quality status of comparators imported from outside the EU and the responsibilities of the QP in respect of these.

With just over a year to go to expected implementation, manufacturers are understandably concerned at the lack of clarity. A year is not a long time in pharmaceutical development and quite reasonably industry is seeking early answers to these crucial questions.