The MHRA is launching an online Innovation Office to help medical groups with their pioneering products.
is specifically looking to help those firms who are creating innovative
medicines, medical devices or using novel manufacturing processes to
pilot through the regulatory processes, in order to be able to help
progress these products.
The Office will be a web-based
portal accessed via the UK drug regulator’s website. The main aim of the
Innovation Office will be to promote early dialogue between innovative
organisations and the MHRA in order to help facilitate their
understanding of the regulatory considerations applicable to their
For example, the MHRA says it can advise on
the development of innovative products like advanced therapies,
nano-medicines and drug device combinations.
such technologies will be able to fill in a simple form about their
inquiries, which will be submitted confidentially to the most
appropriate person at the MHRA.
MHRA director of licensing,
Dr Ian Hudson, said: “We’re looking forward to providing advice and
assistance to companies who are developing innovative products or
exploring innovative approaches.
“Developers of novel
technologies or products are often unsure which UK or European
regulations apply and we hope that our ‘Innovation Office’ will give
them the help they need to understand the regulatory requirements and
pathway for progressing their novel product or approach.”
initiative has been developed as part of the ‘Life Sciences Strategy’
launched by the UK Government in 2011, which helps create incentives for
organisations wishing to promote healthcare innovation.
new online Office works as a part of the strategy and will help to
encourage the growth of the life sciences industry, according to the
MHRA. The regulator said there will be no fee for contacting the
Innovation Office, though there could be a fee for subsequent meetings.