Brexit Bites EMA: Huge Staff Losses Freeze Many Projects
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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The European Medicines Agency says the unprecedented public interest in treatments and vaccines being developed for COVID-19 has highlighted the need to provide access to more information than usual.
The European Medicines Agency’s clinical data publication policy is on hold, but calls are growing for the regulator to start publishing trial data for COVID-19 treatments and vaccines as soon as they are authorized in the EU.
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.