All Medicines and Healthcare Products Regulatory Agency (MHRA) articles
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Industry newsMHRA provides guidance to streamline safety communication
The Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance on safety communications to ensure that medicines, medical devices and other healthcare products reach ‘high standards of safety, quality and efficacy.’
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Industry newsNew cancer drug approved by MHRA
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new drug for non-small cell lung cancer (NSCLC) via a national procedure.
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Industry newsNICE and EMA say new Alzheimer’s drug is ‘not recommended’
The new draft guidance from NICE states that Lecanemab is ‘not recommended’ and the EMA has recommended the refusal of the marketing authorisation for Leqembi.
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Industry newsMHRA reclassifies codeine linctus as prescription-only
Over-the-counter cough syrups which contain the opioid codeine have been reclassified as prescription-only medicines due to the risk of abuse.
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Industry newsMHRA workplan to support safe access to medtech
The MHRA has published a two-year workplan which will see the introduction of a range of new regulations for medical devices in the UK.
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Industry newsMHRA’s IRP pathway now open for new medicines approvals
Medicines manufacturers can now submit marketing authorisation applications via the MHRA’s International Recognition Procedure.