abpi News
The EU Clinical Trials Directive 2001/20 is due to be implemented by 1 May 2004. The Directive includes significant requirements for the manufacture of clinical trials (CT) materials. In particular, it requires that manufacturing sites will have to be licensed to produce CT supplies and includes formal provisions relating to the release of such materials by a Qualified Person as defined in the medicines Directive 75/319.
As part of the implementation process, the Commission released for comment in November the draft of a revision to Annex 13 of the EU Guide on GMP for medicinal products. This Annex relates specifically to the manufacture of investigational medicinal products.
Consultation on the draft is open until 1 May this year and among the topics that have stimulated comment have been the proposed provisions relating to labelling of CT products and the specific duties of the qualified person in respect of the release of CT material.
For a number of years, manufacturers of CT materials have invited voluntary GMP inspection of their facilities by member states' competent authorities and there is no doubt that this has been valuable in the development of the original Annex 13 and its draft revision as required under the new Directive.
Finalisation of industry's comments on the revised Annex 13 will take place over the next few months, but in the meantime the dialogue between the agencies and industry will continue. The MCA has been particularly proactive by organising a workshop seminar in mid-March to allow an exchange of views on the current proposals.
You will be kept abreast of developments.