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Pharmaceutical Manufacturing and Packing Sourcer
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The European Union is about to enter a new era in the conduct of clinical trials within its jurisdiction. The vastly different range of current approaches from member states to trials are going to converge on 1st May 2004. At least that is the intention. Will we make it on time or will national differences on interpretation make it impossible? Not only that, but how will the new accession countries intending to join the EU in May 2004 fare? In both cases, only time will tell.
This article broadly highlights certain aspects of the changes to clinical supplies as demanded by the Directive (1) and encouraged by the accompanying publication of guidance in the revised Annex 13 (2) to European Good Manufacturing Practice (GMP). Readers may find that these changes already exist in many Member States' legislation, but in most countries the requirements are new.
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