4 January 2010
For a given project, the Tool Kit offers graphical representations of regulatory routes, key regulatory questions and milestones, with detailed information about required steps and contacts for each stage.
The resource was developed by the Department of Health and the Medical Resaerch Council with the support of key regulatory bodies including the Gene Therapy Advisory Committee (GTAC), the Human Fertilisation and Embryology Authority (HFEA), the Human Tissue Authority (HTA) and the Medicines and Healthcare Products Regulatory Agency (MHRA), as well as other groups. It will be updated every three months.
Professor Brendon Noble of the MRC Centre for Regenerative Medicine in Edinburgh commented: “This will be an important tool in therapy development planning. It will also act as a focus for discussion over key issues and roadblocks to the development of cell based therapies” (see press release).