MHRA Post-Transition Period Information

On 1 September 2020 the UK MHRA published guidance for industry and organizations to follow from 1 January 2021.

From 1 January 2021, the MHRA will be the UK’s standalone medicines and medical devices regulator. Stakeholders need to get ready for new rules from 1 January 2021.

The MHRA has issued a series of guidance, effective from 01 January 2021, including guidance on registration of clinical trials for investigational medicinal products and publication of summary results, substantial amendments to a clinical trial, regulating medical devices, licensing, importing and exporting, IT systems, pharmacovigilance, pediatric studies.

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