All MHRA articles
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Industry newsGreater post-market surveillance for medical devices
New draft legislation was laid before the UK Parliament on 21 October 2024 which would require greater post-market surveillance (PMS) for medical devices on the market in Great Britain.
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Industry newsMHRA publishes ‘recognition route’ revised guidance
The MHRA has issued guidance on its International Recognition Procedure, which will replace the EC Decision Reliance Procedure from January 2024.
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Industry newsMHRA plans medical device technologies streamlined pathway
UK agency aims to make route-to-market much more straightforward for manufacturers with Innovative Devices Access Pathway.
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Industry newsMHRA seals deal for fast international recognition routes
UK agency adopts recognition routes from seven national authorities; new signals start of new international framework for medicines.
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Industry newsMHRA reappoints two non-exec directors
Two Non-Executive Directors have been reappointed to the MHRA Board effective from September 1, 2023, according to the Department of Health and Social Care.
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JournalEvolutions in patient healthcare at MHRA
Chief Safety Officer, Alison Cave discusses her role at the MHRA, key objectives and ambitions for the regulator.
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FocusBrexit − Regulatory and supply chain considerations
The UK formally left the EU on 31 January 2020 and the transition period, as set out in the withdrawal agreement, came to an end on 31 December 2020. During this transition period, the UK continued to remain under EU pharmaceutical law. From 1 January 2021, the UK adopted an ...
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FocusPharmacovigilance regulations post-Brexit
The UK (Great Britain and Northern Ireland) has left the EU and the Brexit transition period has passed. This article covers points to consider when ensuring that pharmacovigilance systems for human medicinal products are compliant with EU and UK requirements. The UK requirements largely mirror the existing EU pharmacovigilance (PV) ...
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FocusNew regulatory tools for drug developers: sharing experience
Advances of knowledge in therapeutic areas have led an ease in the development of and access to complex medicinal products. This article discusses the regulatory tools in drug development and regulatory science for drug developers.