UK regulators say they plan to launch an "Innovation Office" to assist the regulatory process, and particularly for those companies developing innovative medicines and devices that need the most help navigating uncharted regulatory waters.
A Borrowed Approach
The approach in many ways borrows from similar ones used around the world. In the US, the Food and Drug Administration (FDA) assists sponsors through a variety of accelerated review programs, including fast track, accelerated approach and priority review. Fast Track review in particular allows the applicant to gain access to more frequent meetings with FDA staff, affording it more advice and guidance to smooth over potential difficulties.
But a proposal from the Medicines and Healthcare Products Regulatory Agency (MHRA) would build upon this idea with the creation of the innovation "office"-it's actually a webpage-that will allow sponsors to "fill in a simple form which will be submitted confidentially to the most appropriate person at the MHRA."
"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," wrote Ian Hudson, MHRA's director of licensing. "The 'office' will help to encourage the growth of the life sciences industry."
An 'Office' of Innovation
Despite the "office's" lack of, well, office, it could have a profound effect on companies wishing to access the UK or EU market by allowing them to understand what is required of them and with fewer delays.
Which raises another question: What exactly is the definition of an "innovative" product? MHRA said it doesn't have a strict definition from which to work, but instead "envisages that the Office will be used by companies, SMEs, academics and individuals who are developing a new technology used for the first time in the healthcare industry, a new material or new type or product."
This notably includes companies looking for advice regarding new delivery systems and novel manufacturing processes as well, MHRA said.
There will be a fee associated with complex queries to the office, which are defined as those requiring further, in-person discussion. Other questions will be answered without charge, and within 20 working days.
Scientific queries will still be covered by MHRA's scientific advice procedure, the agency said in a statement, and will still be associated with a fee.