Guidance is Relevant to DCP/MRP/National Marketing Authorisations CMDh has issued an updated Questions and Answers document regarding Brexit for how Marketing Authorisation activities will proceed in the event of no withdrawal agreement and hence without a transition period. http://www.hma.eu/...
Read moreDIA 2019 Vienna EUDRAC will be exhibiting at the annual DIA Europe Meeting in Vienna, Austria from 5th - 7th February 2019. Our team would be pleased to welcome you at booth number B70 to discuss your potential regulatory affairs, pharmacovigilance and publishing needs. A member of our Management...
Read moreNew 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...
Read moreElectronic 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...
Read moreEMA 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...
Read moreFalsified medicines are recognised as an increasing problem in the EU and the USA where illegal online pharmacies provide the main route of distribution supplying up to 50% of all falsified medicines, according to a WHO-estimation. In the developing world, falsified medicines account for up to 30%...
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