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Rare therapies and UK regulatory considerations

Page summary:
A paper outlining MHRA’s intentions to make it quicker and easier to get rare disease therapies tested, manufactured and approved in the UK.

Change made:
First published.

Time updated:
7:55am, 2 November 2025

Major change for rare disease treatments on way, signals MHRA

Page summary:
New paper sets out UK regulator’s intentions to overhaul rulebook for rare disease therapies in UK

Change made:
First published.

Time updated:
8:11am, 2 November 2025

MHRA calls on public to report side effects and suspected fakes during #MedSafetyWeek

Page summary:
The tenth annual #MedSafetyWeek brings together more than 130 medicines regulators and health organisations across 117 countries to encourage people to report suspected side effects from medicines and device incidents.

Change made:
First published.

Time updated:
12:01am, 3 November 2025

Professor Henrietta Hughes: Putting Patient Safety at the Heart of Regulatory Innovation

Page summary:
Professor Henrietta Hughes reflects on how MHRA strategy must prioritise patient safety via listening to lived experiences, fostering collaboration & innovation.

Change made:
First published.

Time updated:
11:26am, 3 November 2025

MHRA strategy blog series

Page summary:
A series of articles from influential external voices about the challenges and opportunities ahead.

Change made:
Published latest in the series of guest blogs: ‘Professor Henrietta Hughes: Putting Patient Safety at the Heart of Regulatory Innovation’

Time updated:
11:26am, 3 November 2025

MHRA appoints first Chief Medical and Scientific Officer

Page summary:
Professor Jacob George has been appointed as the first Chief Medical and Scientific Officer for the Medicines and Healthcare products Regulatory Agency (MHRA).

Change made:
First published.

Time updated:
10:00am, 4 November 2025

Register medical devices to place on the market

Page summary:
How to register your medical devices with the MHRA for the markets in Great Britain and Northern Ireland.

Change made:
Updated fees implementation and management guidance, to correct minor typos only, no change to content.Updated link to survey on fees implementation and management guidance

Time updated:
3:52pm, 5 November 2025

Dr Alison Cave: Pharmacists are on the frontline of medicines safety – and your reports make all the difference

Page summary:
As part of #MedSafetyWeek, the MHRA’s Chief Safety Officer reflects in The Pharmacist on the vital role pharmacists play in keeping medicines and medical devices safe.

Change made:
First published.

Time updated:
5:13pm, 7 November 2025

Ben Kemp