A Publicly Available Specification (PAS) that defines the terms commonly used in the field of regenerative medicine has been published by BSI British Standards.
PAS 84, Regenerative Medicine – Glossary, provides clear guidance on the meaning of terminology currently used in the UK by industry, regulators, government and academia. The glossary will help the key stakeholders to communicate more effectively and allow the commercialisation of the new technology to take place more efficiently and safely.
Developed in consultation with UK stakeholders, this document is intended to help:- Facilitate a common understanding of the science of regenerative medicine; - Prepare for legal, commercial and societal issues; - Improve communication and understanding of the science of regenerative medicine; - Demonstrate best practice and product quality; - Reduce research, development, production and transaction costs.
PAS 84 contains over 200 definitions in the areas of cell and tissue components, non-cellular components, cell and tissue procurement, measurement and analysis, manufacturing and production and clinical trials. These include: - Tissue bank: collection of characterised tissues for clinical utility; - Cell authenticity: degree to which a population of cells has the correct identity and is free of other cell types; - Safety: freedom from unacceptable risk.
PAS 84 follows the publication of PAS 83, Guidance on codes of practice, standardised methods and regulations for cell-based therapeutics in November 2006. This standard was written in response to the increased scrutiny of current standardisation and regulations by researchers, manufacturers and the general public as cell-based therapeutics have moved nearer to commercialisation. Both PAS 83 and PAS 84 are available for download, free of charge. Mike Low, director of BSI British Standards, said, “Regenerative medicine is a rapidly expanding area and it is vital that standards are put in place to facilitate developments in research, manufacturing and implementation. BSI British Standards will continue to develop standards in this field.”
In response to rapid growth in the area of regenerative medicine, BSI British Standards has established a new committee, RGM/1 (Regenerative Medicine). Included in its remit, the committee will: - Ensure the UK view is given due consideration within the European Union, and European and International standardisation organizations; - Develop and support formal standards and other standardization documents in the area of regenerative medicine and to promote their use by industry and other potential users - Ensure due consideration of the need for standards and standardisation is given by UK regenerative networks and organisations, and to coordinate activities and actions in this area.
Dr Julian Braybrook, head of measurement R and D at LGC and chair of the newly established committee, said, “I am delighted to be working with BSI British Standards and a committee which captures such wide expertise to ensure that the UK is at the forefront of progress in regenerative medicine. The next few years promise exciting developments in this field and standardisation will play a vital role.”
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