The EMA says it will further scale back operations as staff who do not intend to relocate to Amsterdam next year begin to depart the agency.
“The temporary cuts in activities are required because it has also become clear that the agency will lose more staff than initially anticipated,” the EMA says, noting that it expects staff departures to accelerate as the move to Amsterdam in March 2019 approaches.
The EMA says it now expects to lose 30% of its staff ahead of the move and is uncertain about mid-term staff retention once it begins operations in Amsterdam. A survey of EMA staff conducted ahead of the European Council’s vote to determine the agency’s new home found that Amsterdam was the most favored location by staff, with only 19% reporting they would not relocate with the agency.
Due to employment rules in the Netherlands, the EMA says it will not be able to bring some 135 short-term contract employees with it in the move.
Bracing for the departures, the EMA says it has launched a comprehensive staff recruitment program, but in the near term will have to “reprioritize its resources to fully maintain its core activities,” such as reviewing marketing authorization applications and overseeing safety surveillance.
By 1 October 2018, the EMA says, it will have scaled back additional non-core activities.
On an international level, the agency will continue to focus on product specific issues and will still carry out Article 58 procedures, but will reduce its role in harmonization efforts and take on other global public health issues “on a case-by-case basis.”
The EMA will also halt the publication and revision of guidelines except those that address an urgent public or animal health need, or that directly relate to Brexit.
Similarly, the agency will limit itself from organizing and attending stakeholder meetings that are not related to Brexit or its relocation.
The EMA also says it will stop launching new procedures related to clinical data publication as of August, but will process all data packages submitted through July 2018.
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.
Image: The EMA’s new offices in the Zuidas, Amsterdam. SHUTTERSTOCK
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