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Standard: Implementation of medical devices future regime
Information on the new regulations for the post-market surveillance of medical devices which come into effect on 16 June 2025.
Research: Review of risk minimisation for disabling and potentially long-lasting/irreversible side effects associated with fluoroquinolone antibiotics
Public Assessment Report on the review of risk minimisation for fluoroquinolone antibiotics.
Designated standards prioritisation
The MHRA invite feedback on the use of designated standards for medical devices and in vitro diagnostic (IVD) devices to help shape future initiatives.
Class 2 Medicines Recall: Paracetamol 500mg Tablets, Chelonia Healthcare Limited, EL(25)A/25
Chelonia Healthcare Limited is recalling specific batches of Paracetamol 500mg Tablets (100 pots) as a precautionary measure due to contamination following a small number of complaints of discoloured tablets within the pots.
Brensocatib licensed as the first medicine specifically designed to treat non-cystic fibrosis bronchiectasis in patients 12 years and older
As with any medicine, the MHRA will keep the safety and effectiveness of brensocatib under close review.
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.