GMP News No. 804
2 October 2006
EMEA Aims at Harmonising the
The new document is based on the guideline ICH Q5A, to which it includes a number of references. Therefore, it is useful to have this ICH guideline to hand when reading the draft.
The new guideline shows different approaches to reducing the scope of virus safety tests and validation studies for clinical phases I and II under certain circumstances. These circumstances include:
Apart from detailed data, an additional risk analysis of these individual aspects is meant to be presented. Here it is important that this approach is only possible for cell lines that are classified "Case A" and "Case B" according to ICH Q5A.
Paragraph 4.2.4 of the draft explicitly refers to the conditions under which the programme for virus validation studies in clinical phases I and II can be reduced:
On the whole, the relaxation of the requirements for clinical phases I and II are subject to a large number of ifs and buts. The practice will have to show that the proposed methods will be used by the industry and approved by the registration authorities.
However, independently of the outcome, the main target of this guideline, namely to harmonise the requirements on clinical trials Europe-wide, is in itself a positive aspect.
The Draft GUIDELINE ON VIRUS SAFETY EVALUATION OF BIOTECHNOLOGICAL INVESTIGATIONAL MEDICINAL PRODUCTS can be found at the following address: http://www.emea.eu.int/pdfs/human/bwp/39849805en.pdf.
Comments can be handed in until 31 December 2006. The discussions at our events show time and again that too few firms take the opportunity to comment on such drafts. Keep in mind that this is your opportunity to influence EMEA requirements directly and not just via industrial associations.