PAS 83:2006 Guidance on codes of practice, standardised methods and regulations for cell-based therapeutics – from basic research to clinical application

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This Publicly Available Specification (PAS) has been developed by the Department of Trade and Industry (DTI), with the British Standards Institution (BSI) to inform industry of the standards necessary for cell-based therapies to be used in clinical trials in the UK.

The PAS gives guidance on the product pathway from cell/tissue donation to clinical trial within the UK for cell-based therapies. It describes the accompanying legislation, codes of practice, guidance documents and standards for this process.

It is anticipated that the end-users of this document will range from academic groups who may need to implement quality systems and have an awareness of the overall process to commercialization, to SMEs and larger industrial companies, who may liaise with academic groups or may use the document as a check list for product development. For researchers new to the field, this document will give an appreciation of the level of regulation, guidance and associated quality issues that apply to cell-based therapeutics.

The general public will have access to this document and it is anticipated that, as they understand that some of the more ethical issues are under strict regulation, they may feel more reassured about cell-based therapy research.

It is intended that this PAS will act 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 as in depth examination of the supporting literature. The PAS will act as a guide to point readers in the direction of the relevant legislation, guidance document or standard.

“Cell-based therapeutics is a rapidly advancing field that offers tremendous potential for advances in healthcare. The UK benefits from a strong body of regenerative medicine expertise coupled to a supportive regulatory environment. Building on this, it is the Government’s aim to make the UK a global leader in the translation of this technology into practical medical therapies.”
Lord Sainsbury former Minister for Science and Innovation 

This PAS does not cover xenografts, whole organ or bone marrow transplants and blood transfusions.

THE HARD CELL article published in Business Standards magazine (February 2007) [PDF 151kb].

Read BSI's  press releases for PAS 83:

New guide to help UK to be Global leader in stem cell research

PAS 83 - Stem cell research guidance is available for review

Download your free copy of PAS 84 Regenerative medicine. Glossary in PDF format

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