UK MHRA promises easier route through regulatory maze for health tech innovations
This article was originally published in Clinica
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has today unveiled a solution to what medical devices director John Wilkinson recently described as the agency’s desire to address innovation challenges in a “positive and creative way” (www.clinica.co.uk, 6 February 2013). The Innovation Office aims to “promote early dialogue between innovative organisations and the MHRA, to help facilitate their understanding of the [relevant] regulatory considerations” in each healthcare product segment: devices, pharma, drug-device combinations, advanced therapies and nanotech. Firms will be able to access a web-based portal (via the MHRA) and submit an application that will then be forwarded to the most appropriate person available at the MHRA, and establish a direct contact. The service aims to help steer new firms through both the optimum development pathway and through the regulatory requirements involved, said the agency.