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Brexit Bites EMA: Huge Staff Losses Freeze Many Projects

Executive Summary

The EMA is halting its cherished transparency initiative on study data as it reckons with the fact that many of its employees will not be relocating to its new headquarters in Amsterdam. International collaboration, guidelines development and revision, and the agency's involvement in stakeholder meetings will all be cut back.

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Big Win For EMA On Transparency

The European Court of Justice has confirmed the European Medicines Agency’s approach to disclosure of data submitted as part of a marketing authorization application. It is a big disappointment for industry, which nonetheless says it supports responsible data sharing and will support efforts to develop a balanced approach.

EMA Set For More Staff Losses & Activity Cuts Next Year

The latest EMA management board meeting heard an update on the situation regarding Brexit-related staff losses and recruitment, and was told that an additional set of temporary suspensions or reductions in its activities might be necessary from the beginning of 2019.

No Quick End To Brexit Activity Hold At EMA

As the European Medicines Agency gears up to implement its carefully crafted Brexit business continuity plan, it hopes to be in a position to reintroduce some of its currently suspended/reduced activities in the second half of next year.

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