PAS 84:2012 Cell therapy and regenerative medicine. Glossary
Download the pdf of PAS 84 (3 MB) here
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 of regenerative medicine. PAS 84, Regenerative Medicine – Glossary, 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.
PAS 84 follows the publication of PAS 83, Guidance on codes of practice, standardized methods and regulations for cell-based therapeutics in November 2006. This standard was written in response to the increased scrutiny of current standardization and regulations by researchers, manufacturers and the general public as cell-based therapeutics have moved nearer to commercialization.
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.
PAS 84 lists the following terms and definitions associated and applicable to regenerative medicine:
Associated with the naming of types of regenerative medicine products and therapies.
That describe materials, processes, methodologies and applications within regenerative medicine.
Contents of PAS 84 includes:
- General terms
- Cell and tissue components
- Non-cellular components
- Cell and tissue procurement
- Measurement and analysis
- Manufacturing and production
- Clinical trials
- Regulatory terms for clinical trials, products and therapies
*For the purpose of this PAS, regenerative medicine is defined as:
“replaces or regenerates cells, tissues or organs, to restore or establish normal function”.
PAS 93:2011, Characterization of human cells for clinical applications. Guide – from basic research to clinical application can also be downloaded for free. Download your free PDF version.