Category MHRA (UK)

UK and Singapore launch a regulatory innovation corridor to speed up access to breakthrough therapies in high-impact areas

Patients in the UK and Singapore could gain faster access to cutting-edge healthcare innovations under a new partnership bringing two globally respected regulators together with one of the world’s leading biotech creators. As part of this first-of-its-kind regulatory collaboration between…

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MHRA and NICE launch an aligned pathway to publish regulatory and health technology assessment decisions simultaneously

The MHRA and the National Institute for Health and Care Excellence (NICE) have launched an aligned pathway. This is a joint initiative designed to streamline the scheduling of the regulatory approval and health technology assessment processes in order to reduce…

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MHRA guidance on medicines MAH submission of nitrosamine risk evaluation, risk assessment and confirmatory testing updated

This guidance has been updated to include sections on the following: Lifecycle management MAHs are reminded of their responsibilities to ensure the quality, safety and efficacy of their medicines and are expected to continue to review and re-visit the outcome…

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