Clinical trials Route B substantial modifications pilot starts on 1 October 2025. Prepare for the implementation of new regulations from 28 April 2026.
Similar Posts
Medicines recall of all quetiapine oral suspension batches from Eaststone Limited due to incorrect amount of active ingredient
Batches of quetiapine oral suspension from Eaststone Limited are being recalled due to the active content being twice the amount it should be. Patients should not stop taking this medicine without consulting their healthcare professional.
AI breakthroughs drive expansion of ‘Airlock’ testing programme to support AI-powered healthcare innovation
MHRA opens second round of applications to test cutting-edge AI medical technologies following successful pilot phase.
Clinical trials for medicines: labelling
Guidance on labelling for medicinal products used in clinical trials.
Guidance: Medical devices: legal requirements for specific medical products
Information for manufacturers on the regulations that apply to prosthetic, orthotic and ophthalmic devices.
Corporate report: MHRA Corporate Plan: 2023 to 2026 and Business Plan: 2025 to 2026
These reports outline the MHRA’s Corporate and Business Plans, detailing the agency’s strategic direction over the next three years.
MHRA approves teplizumab to delay progression of type 1 diabetes
As with any medicine, the MHRA will keep the safety and effectiveness of teplizumab under close review.