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The U.S. Food and Drug Administration (FDA) is warning that cases of a rare but serious infection of the genitals and area around the genitals have been reported with the class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors.
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MHRA seizes 7.7 million doses of illegal medicines and removes hundreds of illegal online listings as part of Operation Pangea
Operation Pangea brings together health regulators, customs authorities, law enforcement agencies, and private sector partners to tackle the threat posed by global criminal networks
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Class 2 Medicines Recall: Depo-Medrone 80 mg in 2 mL, Maxearn Limited EL(25)A/29
A batch of Depo-Medrone has been released to the market with an error. The vial over label incorrectly states that the total vial content is 40 mg in 1 mL, when the correct total vial content is 80mg in 2 mL (with a concentration of 40mg/ml of methylprednisolone acetate).
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Form: Medicines: variation forms for a manufacturer’s licence
Forms to make a variation to a manufacturer’s licence.
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Class 3 Medicines Recall: Kimmtrak 200 micrograms/mL concentrate for solution for infusion, Immunocore Limited, EL(25)A/28
Immunocore Limited is recalling the batches listed below as a precautionary measure. The recall is due to a decrease in potency identified during stability testing. All other stability test results remain within specification.
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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.
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MHRA publishes final Business Plan for 2023-2026 Corporate Plan
The new Business Plan sets out priorities for 2025–26: Protecting public safety and maintaining public trust; delivering efficient, predictable services through regulatory excellence; being an agile organisation that drives innovation; being a great place to work and providing excellent customer service.
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Clinical trials for medicines: apply for approval in the UK
How to apply for a clinical trial from 28 April 2026, including eligibility, phases, model IMPDs, costs and how to make changes to your application.
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Clinical trials for medicines: expert advice
Clinical trial applications that need expert advice from a specialist group or committee.
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Clinical trials for medicines: labelling
Guidance on labelling for medicinal products used in clinical trials.
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Clinical trials for medicines: notifiable trials
Guidance on categorising certain clinical trials as ‘notifiable’.
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Clinical trials for medicines: ending a clinical trial
Guidance on the process for ending a clinical trial.
