An overview of the process including submitting or fast-tracking an application, naming your medicine and paying fees.
Similar Posts
Patients to benefit as UK and US regulators forge new collaboration on medical technologies and AI
Enhanced collaboration with the US on med tech regulation, with accelerated innovation, strengthened patient safety, and reduced transatlantic barriers to market access.
Field Safety Notices: 6 October to 10 October 2025
List of Field Safety Notices from 6 October to 10 October 2025.
Trinity Biotech Premier Hb9210™ HbA1c Analyser: Risk of Positive Bias and Updates to Instructions for Use (IFU), including use as a diagnostic aid in diabetes mellitus (DSI/2025/003)
The MHRA has received reports describing a positive bias in HbA1c results delivered by the Trinity Biotech Premier Hb9210 HbA1c analyser, which has resulted in patients being incorrectly diagnosed as pre-diabetic or diabetic.
MHRA Safety Roundup: September 2025
Summary of the latest safety advice for medicines and medical device users
Official Statistics: Quarterly reports on the import of unlicensed medicines
Details and statistics on the import of unlicensed medicines from March 2014 onwards.
MHRA outlines intent to speed up patient access to innovative medical devices
Statement of Policy Intent sets out initial thinking on a new Early Access service to help patients benefit sooner from innovative medical devices that address unmet clinical needs.
