As UK Prime Minister Theresa May’s Brexit deal is expected to be rejected Tuesday in a House of Commons vote, the EMA has said that after closely monitoring staffers’ intentions to relocate to Amsterdam, it currently expects a staff loss of about 25%.
The 25% figure might seem like a lot of staffers to lose (about 225 of 900 lost), but that figure is on the low end of predictions from a survey in September 2017 that found EMA expected to lose at least 19% of its staffers no matter which city was selected.
In addition to the staffing losses, EMA said it will further temporarily reduce or suspend activities in the first half of 2019 as it moves into the final phase of its physical relocation. EMA said it will launch such measures as part of a fourth and final phase of the business continuity plan as of 1 January.
For instance, between 11 February and 15 March 2019, no pre-submission meetings for initial marketing authorization applications will take place, while EMA moves to its new premises. EMA will also not print or dispatch certificates for pharmaceutical products from 25 February until 14 March 2019, though companies can still submit requests during this period, which EMA will continue to process.
“Temporary suspension and scaling back of activities is currently scheduled to last until 30 June 2019. Current staffing projections should allow EMA to gradually resume these activities as of July 2019. EMA will review this in April 2019, once it has moved to its temporary building in Amsterdam,” EMA said.
And staff relocation to the permanent building is slated to be finalized by 31 December 2019.
The agency said that despite the halting of certain activities, it expects all core activities related to the evaluation and supervision of medicines “to continue without any interruption or delays foreseen and to the same quality.”
The agency also said it will provide more information on this fourth phase of the continuity plan and its activities during this critical period shortly.
First published here. Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Email email@example.com for more information.
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