EMEA Aims at Harmonising the Requirements on Biotechnological Medicinal Products in Clinical Trials

GMP News No. 804

GMP News
2 October 2006

EMEA Aims at Harmonising the Requirements
on Biotechnological Medicinal Products in Clinical Trials

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.

Dr Ulrich Herber
On behalf of ECA

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