The UK has a strict, but permissive, regulatory framework in place covering all forms of human stem cell research which balances the need for governance and commercial development. Of note are the following:
Steering Committee for the Stem Cell Bank and for the Use of Stem Cell Lines
An independent high-level steering committee oversees the activities of the UK Stem Cell Bank and the use of human stem cell lines in the UK. All projects using human embryonic stem cell lines in the UK are expected to have been approved by the Steering Committee.
Code of Practice for the use of hESCs
All research involving the use of human embryonic stem cell lines must comply with the Code of Practice for the use of human stem cell lines. This is a requirement of research supported by MRC funding.
Regulatory Support Centre
Provides support and guidance for those conducting research with human participants, their tissues or data.
MHRA Regulatory Advice Service for Regenerative Medicines
This advice service offers research and development professionals across academia, industry and the NHS (including clinicians) a single point of access to free, joined-up regulatory information, advice and guidance from the Health Research Authority (HRA), Human Fertilisation & Embryology Authority (HFEA), Human Tissue Authority (HTA), National Institute for Health and Care Excellence (NICE), and specialists across the MHRA, CPRD, and NIBSC.
International Regulation
International differences in regenerative medicine regulation are seen as a potential risk to the field’s development. In 2013 a group of organisations, including the MRC, sponsored the ‘International Workshop on Regulatory Pathways for Cell Therapies’ to ascertain differences and potential areas of convergence in the regulatory approach of different international regulators. The members of the sponsor group included: California Institute for Regenerative Medicine (CIRM), Alliance for Regenerative Medicine (ARM), Economic and Social Research Council (ESRC), Cell and Gene Therapy Catapult and the Canadian Centre for Commercialization of Regenerative Medicine (CCRM). The report from the workshop is available through the link provided here.
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