By Richard Stubbs
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Class 2 Medicines Recall: Sterling Pharmaceuticals Ltd (specials manufacturer MS 32515), KidNaps (Melatonin) 1mg in 1ml Oral Solution, EL(26)A/09
Sterling Pharmaceuticals Ltd and Veriton Pharma Ltd are recalling all batches of KidNaps (Melatonin) 1mg in 1ml Oral Solution due to out of specification stability results.
Decentralised manufacture: UK Guideline on Good Manufacturing Practice (GMP)
UK guideline on GMP for decentralised manufacturing, ensuring compliance with EU GMP principles for safe, quality medicinal products.
Mirvetuximab soravtansine approved to treat adult patients who have ovarian, fallopian tube or primary peritoneal cancer
The approval is supported by a study involving 453 adults with advanced platinum-resistant cancers of the ovary, fallopian tubes and the peritoneum that were FRα positive
Electronic Common Technical Document (eCTD) submissions update
Since, April 2024, the MHRA has been using Lorenz DocuBridge for eCTD management in product license submissions. This change is part of the modernisation of the MHRA’s Legacy Systems and is one of the initial tools launched in the RegulatoryConnect programme.
Field Safety Notices: 24 to 28 November 2025
List of Field Safety Notices from 24 to 28 November 2025.
100 years of protecting patients through biological standards for medicines
The MHRA produces over 95 per cent of the World Health Organization’s (WHO) biological standards.