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On 28 June 2006, the EMEA published a draft guideline on virus safety
evaluation of biotechnological IMPs (Investigational Medicinal Products).
It is the aim of this document to harmonise the requirements within the
European Union. Since the responsibility for clinical trials lies with the
individual member states, currently the requirements to a sponsor of
clinical trials can vary from country to country.
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:
- The nature of the production cell line
- History of the cell line and its use
- Extent of characterisation of the cell line
- Use of starting materials of human and/or animal origin
- Risk potential through adventitious contamination
- Developmental stage of the product
- The company's experience with the cell line in question
- The company's experience with specific inactivation and removal
methods
- Published data
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:
- Non-use of materials of biological origin both during the development
of the cell line and in the production process
- Consideration of data published on the implemented inactivation and
removal steps - but under the premise that extensive comparative studies
have proven that there is a sound scientific rationale for transferring
the results to the process in question
- Prior experiences of the manufacturer with certain process steps for
similar products, where the results of the former validation studies can
be transferred to the new process under certain circumstances
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. Author:
Dr Ulrich Herber
On behalf of ECA
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