Reinventing the wheel

Partnership in early drug development

June 2013
MHRA launches online ‘Innovation Office’
Published: 14/03/2013

The MHRA is launching an online Innovation Office to help medical groups with their pioneering products.

It 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 innovation. 

For example, the MHRA says it can advise on the development of innovative products like advanced therapies, nano-medicines and drug device combinations.

Developers of 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.” 

The 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.

The 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.

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