Nearly 20 million doses of potentially dangerous medicines prevented from reaching the public
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Clinical trials for medicines: apply for authorisation in the UK
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
MHRA and NICE invite early adopters to trial accelerated aligned pathway – six months ahead of schedule
Aligned pathway will streamline decisions on licensing and value for medicines, helping patients to benefit from them sooner.
Mirdametinib approved to treat plexiform neurofibromas in children, adolescents, and adults with neurofibromatosis type 1
As with any medicine, the MHRA will keep the safety and effectiveness of mirdametinib under close review.
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.
Decentralised Manufacture: UK Guideline of Good Pharmacovigilance Practices
Guidance covering various aspects of pharmacovigilance for authorised and unauthorised medicinal products (Specials and the Early Access to Medicines Scheme (EAMS)).
M6-C Artificial Cervical Disc, Spinal Kinetics LLC: New monitoring requirements for the risk of osteolysis
The MHRA has conducted an assessment following reports of osteolysis and early device failure in the literature and is issuing new monitoring requirements for patients implanted with the M6-C artificial cervical disc.
