Please login to the form below

Not currently logged in

MHRA launches virtual 'innovation office'

Aims to smooth regulatory pathway for companies developing novel medicines, devices or technology

Innovation light bulbThe Medicines and Healthcare products Regulatory Agency (MHRA) has set up an online 'innovation office' to help companies who are developing innovative medicines and devices.

The UK regulator wants to help firms working on things like novel drug-device combinations or nanomedicines to navigate its regulatory processes through early dialogue.

The 'office' takes the form of a dedicated section within the MHRA website, through which companies fill out a contact form that will then 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 MHRA acknowledged the difficulty of definitely describing what constitutes a novel or innovative medical device, but said it would be interested in considering the regulatory impact of devices or technologies that are “transformational or provide a step change”.

“We would be particularly interested in discussing technology or products that could potentially challenge the current regulatory framework, due to their novel technology, materials used or as a result of convergence of technology, whereby a technology that is established in other fields is applied to medical devices for the first time.”

Areas of technology that are a current focus for the regulator include novel materials, regenerative medicine, nanotechnology, synthetic biology and software as a medical device.

The innovation initiative is part of the UK government's Life Sciences Strategy, which was launched in 2011 to help create incentives for organisations wishing to promote healthcare innovation.

There will be no fee for contacting the Innovation Office, though the MHRA said it may levy a fee for subsequent meetings.

12th March 2013

From: Regulatory



Featured jobs

Subscribe to our email news alerts


Add my company

Conversis is a translation company specialising in translation and localisation for the Life Science and Pharmaceutical industry, with particular focus...

Latest intelligence

AstraZeneca’s oncology renaissance
Susan Galbraith played a key role in restoring AstraZeneca’s place in cancer drug development – she talks about the future of oncology and why there’s more to be done to...
Navigating the antibiotic resistance crisis
Blue Latitude Health speaks to Tara DeBoer, PhD, Postdoctoral Researcher and CEO of BioAmp Diagnostics to explore the antimicrobial resistance crisis, and learn how a simple tool could support physicians...
Combined immunotherapies – potential and pitfalls
‘Combining therapeutic compounds is the first logical step towards better results, namely higher rates of patients responding to treatment, with deeper and more sustained responses’...