March 8 2007
The British Standards Institution’s (BSI) Publicly Available Specification (PAS) to map and inform industry and researchers of the critical path requirements for the development of stem cell therapeutics is now available for review before purchase.
PAS 83 - Guidance on standards, standardized methods and regulation for cell-based therapeutics, from basic research to clinical application was commissioned by the Department of Trade and Industry (DTI) and produced in collaboration with key stakeholders across the UK including stem cell researchers, the biotech industry and regulators. The PAS explains which laws need to be adhered to and highlights important guidance and standards pertinent to each stage of the research and development process.
What is PAS 83?
PAS 83 is designed to raise awareness of relevant laws and standards across the stem cell community and to promote best practice across both academic and commercial stakeholder groups. It is intended that this PAS will act as a quick reference source on the requirements for exploitation of a cell-based therapy in the UK.
The government aims to make the UK a global leader in stem cell science and to enable its application to the commercial development of new therapeutics to treat a variety of diseases. By making PAS 83 widely available via the BSI website it is hoped that this will increase reassurance amongst the general public that the complex ethical issues surrounding cell-based therapy research are under strict regulation.
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