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February 2009 saw the introduction of new regulatory guidance governing the virus safety of investigational medicinal biotechnology products (IMPs) (1). The development of this guideline has enabled a more pragmatic approach to ensuring virus safety of IMPs, seated firmly in the principles of risk-based management. The process of developing the guideline started in 2004 with the publication by the EMEA of a concept letter detailing the proposed scope of the new guideline. The need for such guidance stemmed from a lack of clear regulation regarding the point in development that full ICH Q5A compliant testing should be applied. The ICH Q5A guidelines are specifically applicable to products proceeding into marketing authorisation, but the requirements for products in clinical development have never been clearly specified (2).
Following extensive discussion at a joint European Medicines Agency (EMEA)/FDA/Parenteral Drug Association (PDA) forum on the virus safety of investigational products at the end of 2005, the first draft was published in June 2006. Subsequent consultation with industry resulted in refinements that led to the final guideline, published towards the end of 2008. The new guidance is a leading example of how industry and regulators have worked together to provide a workable solution to assure the virus safety of IMPs. The nature of this collaboration between industry and regulatory bodies is embodied in the companion document to this guidance, which takes the unique approach of publishing both industry’s comments, as well as the regulators’ responses as to how any concerns raised were addressed, enabling a more comprehensive understanding of the contents of the guidance (3).
This article provides an overview of the key components of this new guidance, and how the application of risk-based management was used to reach the final requirements for manufacturers when testing IMPs. |
