Even though the IRP involves the dossiers of the reference regulator’s submission, this procedure is entirely evaluated by the MHRA for approval under the UK market. Hence, it is evident that module 1 in eCTD structure should be submitted according to UK specific guidelines to the agency.1 Fi...
BSACI guidelines for the investigation of suspected anaphylaxis during general anaesthesia The MHRA should be notified. Investigation of anaphylaxis during general anaesthesia should be focussed in major allergy centres with a high throughput of ... PW Ewan,P Dugué,R Mirakian,... - 《Clinical & ...
“Elafibranor is the first medicine for PBC in nearly a decade, offering a promising new treatment option for people living with this rare condition. This is especially significant for those who may need an additional option beyond current first-line treatments. The MHRA’s decision represents re...
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