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Form: Medicines marketing authorisation: change of ownership application
Use this form to transfer a product licence, also known as a marketing authorisation, to a different owner.
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.
Class 3 Medicines Recall: Glenmark Pharmaceuticals Europe Limited, Fingolimod Glenmark 0.5 mg Hard Capsules, EL(26)A/02
Glenmark Pharmaceuticals Europe Limited is recalling one batch after stability testing showed out-of-specification results. The batch is being recalled as a precautionary measure following test results that showed a delay in capsule dissolution.
Guidance: Route B substantial modification pilot
Clinical trials Route B substantial modifications pilot starts on 1 October 2025. Prepare for the implementation of new regulations from 28 April 2026.
Consultation on the International Council for Harmonisation (ICH) E21 Guideline on the Inclusion of Pregnant and Breast-feeding Individuals in Clinical Trials
The MHRA is consulting with UK stakeholders to gather feedback and comments on a new international guideline for the appropriate inclusion and/or retention of pregnant and/or breast-feeding individuals in clinical trials of medicines.
MHRA begins recruitment for new digital roles at Leeds hub to drive innovation and smarter regulation
New jobs to strengthen innovation, safety and smarter regulation across the UK health and life sciences sector.