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UK MHRA promises easier route through regulatory maze for health tech innovations

This article was originally published in Clinica

Executive Summary

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” (, 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.