Brexit: How The UK MHRA And Its EU Roles Could Be Affected
The UK MHRA’s latest annual report reveals how much income the agency receives for activities it carries out on behalf of the European Medicines Agency, and looks among other things at how the MHRA should address the challenges raised by Brexit.
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Dutch officials took part in the December meeting of the EMA management board and presented details of their plans for the agency’s relocation to Amsterdam. The board also adopted the 2018 work program and budget, which allow for a 6.8% rise in fee-related revenue next year, and said phase 2 of the Brexit business continuity plan would begin in January.
The European Medicines Agency has updated its 2007 guideline on the strategies drug sponsors should apply to identify and mitigate risks in first-in-human trials to provide additional advice on dosing issues and the use of integrated protocols, among other things. The revised guideline will apply from February 2018.
The UK Medicines and Healthcare products Regulatory Agency is relocating to the very area in east London the European Medicines Agency is being forced to abandon.