The 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.