The European market for regenerative medicine products is estimated to reach $15bn by 2010 with 50% of the market being derived from products likely to come on to the market in the next 5-10 years.
BSI British Standards has been working closely with the UK research base, academia, regulatory bodies and other relevant organizations (in both the public and private sector) to better understand the challenges faced by this industry today. BSI is seeking to find ways of supporting UK stakeholders by providing guidance documents, codes of best practice and, ultimately, formal standards in this field.
BSI attracted over 40 delegates to the Regenerative Medicine Forum which took place at BERR’s conference centre on Tuesday 26 February. Key UK stakeholders shared the latest developments in regenerative medicine, and delivered their vision for the future. There was a compelling mandate for the UK to take part in and lead standardization in this area, both internationally and in Europe, and overwhelming support for the suggestions put forward. The suggestions included proposals for producing guidance documents for best practice in ensuring stem cell stability and in stem cell processing.
As a result of this mandate, BSI has established a new standards committee in regenerative medicine, RGM/1. The terms of reference for the committee are:
- To mirror the work of ISO/TC 150/SC7 "Tissue-engineered medical products"
- To formulate a UK strategy for standardization in regenerative medicine through a broad consultation with relevant stakeholders
- To ensure the UK view is given due consideration within the European Union, CEN, ISO and IEC
- To 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
- To ensure due consideration of the need for standards and standardization is given by UK regenerative networks and organisations, and to coordinate activities and actions in this area.
In addition to this, BSI recently published Regenerative Medicine Glossary (PAS 84). This Publicly Available Specification (PAS) has been developed to encourage the use of common terms and definitions within the field of regenerative medicine. It defines the terms commonly used in the field and provides clear guidance on the meaning of terminology currently used in the UK by industry, regulators, government and academia. This will help the key stakeholders to communicate more effectively and allow the commercialization of the new technology to take place more efficiently and safely.
IN 2006 BSI published PAS 83 Guidance on standards, standardized methods and regulation for cell-based therapeutics, from basic research to clinical application. This publication defines the process and overlays the current legislation and standards in order to obtain a picture of the area and identifies relevant gaps.
