The Medicines and Healthcare products Regulatory Agency (MHRA) is opening a web-based portal to help organisations developing innovative medicines, medical devices or using novel manufacturing processes.
The regulatory authority refers to the web-based portal as an ‘Innovative Office’ concept. The companies will be able to access the regulatory processes in order to be able to progress their products or technologies.
“Developers of such technologies will be able to fill in a simple form which will be submitted confidentially to the most appropriate person at the MHRA. This initiative has been developed as part of the Life Sciences Strategy launched in 2011 to help create incentives for organizations wishing to promote healthcare innovation. The ‘office’ will help to encourage the growth of the life sciences industry,” according to a press communiqué.
The key objective of the ‘Innovation Office’ is to promote early dialogue between innovative organisations and the MHRA to help facilitate their understanding of the regulatory considerations applicable to their innovation. For example the MHRA can advise on the development of innovative products like advanced therapies, nano-medicines and drug device combinations.
“We’re looking forward to providing advice and assistance to companies who are developing innovative products or exploring innovative approaches”, stated Dr Ian Hudson, director of Licensing, 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,” he added.