European Medicines Agency
EMA draws up plans to move MHRA work
Which national agencies take on which elements of the work will be revealed early next year, the European Medicines Agency (EMA) decided at its meeting on 13/14 December 2017.
Plans are being drawn up to redistribute the European work of the UK’s medicines safety watchdog in the run up to Brexit.
European Union (EU) business currently carried out by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the Veterinary Medicines Directorate will be shared among the EU’s national drug regulatory agencies, it has been announced.
Which national agencies take on which elements of the work will be revealed early next year, the European Medicines Agency (EMA) decided at its meeting on 13 and 14 December 2017.
A spokesperson for the EMA described the EU network of medicines regulatory agencies as “a very strong and flexible system that is able to adapt to changes as necessary without putting at risk the quality of its work”.
Also following its December meeting, the EMA said that preparing for the withdrawal of the UK from the EU will impact on its work in the coming year. It expects to maintain its core activities in 2018 —which includes deciding drug marketing authorisations — but predicts some other work will have to be “temporarily reduced” or “suspended.”
The EMA will move into temporary offices when it vacates its current home in London’s Canary Wharf and relocates to Amsterdam as its new purpose built headquarters is not expected to be completed until November 2019.
Meanwhile the agency is moving forward with the development of its EU-wide clinical trial portal and data base — which will support the needs of EU clinical research, and which it describes as “the most ambitious IT development project…required by the EU pharmaceutical legislation”.
It has tested a partially completed version of the system and, following feedback, has fixed bugs and is working on suggested improvements.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20204164
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