New MHRA Guidance following a ‘hard’ Brexit On January 3rd the MHRA issued its updated guidance on the regulation of medicines, medical devices and clinical trials in the event of a no-deal Brexit. In this scenario the MHRA would regain sole responsibility for all regulatory activities currently...
Electronic Common Technical Document (eCTD) The electronic Common Technical Document (eCTD) format is a standardised interface and international specification for the pharmaceutical industry to transfer regulatory information, developed by the International Conference on Harmonisation (ICH). The...
EMA SME Information Day EUDRAC attended the SME Information Day "Regulatory Toolbox for Medicines and Combined Devices Developers" held at the offices of the European Medicines Agency (EMA) in Canary Wharf, London on 26th October 2018. SME Information Days provide an update on regulatory affairs...
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