The service will, for the first time, provide a single point of access to regulatory advice from the four regulatory bodies that work in the sector.
The service will help businesses and other organisations to quickly and easily navigate the different regulators and allow them to get the right advice more quickly. It will also provide a single response from the regulators and provide an opportunity for a one to one meeting.
Life Sciences Minister George Freeman said:
“I want to make it as easy as possible for our innovative life sciences sector to get the advice they need to turn their innovations into products that can benefit patients. Regenerative medicine is thriving and the new one stop shop highlights our commitment to ensure that the UK becomes the best place in the world for life sciences.”
The group of regulators will work together to provide cross-regulatory advice. The resource is launched today (13 October 2014) and will sit within the MHRA’s Innovation Office, which already provides scientific and regulatory advice to companies developing innovative medicines and medical devices.
Chris Mason, Professor of Regenerative Medicine at University College London said:
“This is a major breakthrough by the UK’s regulatory agencies. The one stop shop for regulatory advice will accelerate medical progress across all the great scientific breakthroughs made by our stem cell researchers and clinicians.
“This joined up approach to regulation strengthens the UK as a world leader in cell and gene therapies. Streamlining access to crucial advice from the regulators will enable UK scientists, clinicians and companies to more rapidly translate ground-breaking research into game-changing therapies and cures – good news for patients, their carers and the NHS.”
Dr Ian Hudson, CEO of the MHRA said:
“We are excited to be hosting this new initiative, which will further support innovation in life sciences and build on the success of the first 18 months of the Innovation Office, further expanding the service and collaboration with other regulators.
“This joined up approach to advice, combined with other UK life sciences initiatives such as the MHRA Early Access Scheme, will further bolster the UK’s position as a world leader in the development of advanced therapies.”
Dr Alan Clamp, CEO of the HTA said:
“The UK is leading the world in stem cell research, and the establishment of the one stop shop will support this important area of medicine. We have taken a proactive role in convening these discussions and are leading the project to establish the resource. We will continue to work with the MHRA to pilot a streamlined inspection process for those developing Advanced Therapy Medicinal Products.”
Dr Janet Wisely, CEO of the HRA said:
“We fully support this initiative and look forward to working with colleagues to implement it. The HRA has an ambitious improvement programme and fully recognises the need to work effectively with others to fully benefit from investment in the HRA to make the UK a great place to do health research. Researchers have already benefited from our improvements to the Gene Therapy Advisory Committee and our new team of application managers can provide additional practical support to applicants which will complement well with this new development.”
Peter Thompson, CEO of the HFEA, said:
“The one stop shop is a helpful step towards supporting this dynamic sector in a clear and joined-up fashion, and we welcome its introduction.”
The 'One stop shop' can be accessed via the MHRA's innovation office