UK Regulatory Issues: The View from the Researcher

The United Kingdom regulatory landscape as it applies to cell-based therapies is rapidly evolving and constantly produces new information for researchers. This chapter brings together the plethora of information in the form of a process map of the key stages in the life cycle of a cell-based product, from cell/tissue procurement, processing and manufacture, through pre-clinical trials, clinical trials and on to commercialisation and post-launch activities. The critical components of each stage are described, and key issues which are pertinent to the UK researcher are discussed, for example, use of pre-clinical models, documentation requirements for clinical trials. The text goes on to identify which regulations, codes of practice and standards are already available for use in the UK and links them to the life cycle stages. The most recent regulation to be agreed in 2007 in Europe is also discussed. EC 1394/2007 is an amendment of EU Directive 2001/83/EC, and describes overarching regulations of advanced therapy medicinal products (which encompasses cell-based therapeutics).

This information is taken from a Publicly Available Specification (No. 83) which was written by the authors of this chapter and published by the British Standards Institution (BSI) in 2006. It is intended that this PAS acts as a quick reference source to increase clarity for users on the requirements needed for exploitation of a cell-based therapy in the UK, rather than an in-depth examination of the supporting literature.