The pilot will help sponsors prepare for a new substantial modifications process under upcoming regulations, with responses delivered within 14 days.
Similar Posts
Professor Henrietta Hughes: Putting Patient Safety at the Heart of Regulatory Innovation
Professor Henrietta Hughes reflects on how MHRA strategy must prioritise patient safety via listening to lived experiences, fostering collaboration & innovation.
Guidance: Medicines that you cannot export from the UK or hoard
Sets out medicines that cannot be exported from the UK or hoarded because they are needed for UK patients.
Class 2 Medicines Recall: Zaditen 0.25 mg/ml, eye drops, solution, Laboratoires Théa EL(25)A/34
Laboratoires Théa trading as Thea Pharmaceuticals Limited have notified the MHRA of an out of specification event related to environmental monitoring during manufacturing, which may increase the risk of microbial contamination of the medicinal product.
MHRA Safety Roundup: December 2025
Summary of the latest safety advice for medicines and medical device users
Class 3 Medicines Recall: Aspar Pharmaceuticals Ltd, Ibuprofen 200mg Tablets, Ibucalm 200mg tablets, EL(26)A/07
Aspar Pharmaceuticals Ltd is recalling specific batches distributed in Aspar, Almus and Numark livery. The batches are being recalled as a precautionary measure following findings of foil perforations in some blisters.
MHRA designated as WHO-Listed Authority: a milestone for UK life sciences and global health
WHO recognition affirms MHRA’s commitment to regulatory excellence, innovation and global collaboration