How to apply for, update and cancel licences for the manufacture, import and wholesale of human and veterinary medicines.
Similar Posts
Clinical trials for medicines: modifying a clinical trial approval
Guidance on the various types of modifications that can be made to a clinical trial approval.
Class 4 Medicines Defect Notification: Special Concept Development UK Limited, Baclofen 10mg Tablets, EL(25)A/51
Special Concept Development UK Limited has informed the MHRA that the Patient Information Leaflet (PIL) for the batches listed in this notification do not contain the correct safety information.
Clinical trials regulations: transitional arrangements
Guidance on transitional arrangements for applying for clinical trial approval.
Guidance: Digital mental health technology: qualification and classification
Helping manufacturers define the characteristics of their devices and determine the appropriate regulatory qualification and classification.
Patients to benefit sooner as UK boosts clinical trials attractiveness with faster assessments and agile regulation
The MHRA is now setting out the next phase of reforms for 2026, aimed at helping patients access new cutting-edge treatments more quickly and boosting the UK’s competitiveness for global clinical research.
MHRA statement on Pathways clinical trial
As with all clinical trials, the MHRA’s top priority is the safety and wellbeing of the trial participants.