UK lays out regulatory roadmap for stem cell treatments

16 Dec 2009 | News
The UK Department of Health has drawn up a regulatory roadmap to guide stem cell researchers following complaints of bureaucratic complexities.


The UK Department of Health has drawn up a regulatory roadmap to guide stem cell researchers seeking to get treatments to clinics, following complaints that progress is being blocked by bureaucratic complexities.  

The UK Stem Cell Tool Kit is a website that will allow researchers to build a customised map outlining all of the regulatory steps they need to take to translate treatment from the laboratory to the clinic. Researchers will be asked seven key questions and depending on their answers, a route will be generated that provides a list all the regulatory requirements, information and points of contact within the relevant organisation.

The regulatory labyrinth is made self-evident in the fact that developing the website has required input from nine bodies that each have a role in overseeing stem cell research. These are: the Department of Health, the Medical Research Council, the Medicines and Healthcare Products Regulatory Agency, the Gene Therapy Advisory Committee, the Human Tissue Authority, the Human Fertilisation and Embryology Authority, the Health and Safety Executive, the Home Office and the UK Stem Cell Bank.

Brendon Noble of the Medical Research Council Centre for Regenerative Medicine in Edinburgh said the roadmap will be an important tool in therapy development planning, adding, “It will also act as a focus for discussion over key issues and roadblocks to the development of cell based therapies.”

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