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ARTICLE · 06 FEBRUARY 2023

EMA To Reinstate Its Proactive Clinical Data Publication Policy

Cooley LLP
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EMA has decided to restart implementation of its policy to proactively publish clinical data.

United StatesConsumer Protection
Elizabeth Anne Wright
Elizabeth Anne Wright
Anastasia Vernikou
Anastasia Vernikou
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The EMA has announced the decision of its management board to resume its proactive clinical data publication policy after a four year-long pause. The application of the proactive publication policy will follow a staggered approach where priority will be given to data relating to new marketing authorization applications that involve new active substances.

A decision to suspend publication of clinical data was made in December 2018 to support EMA's operational continuity during re-location of its headquarters from London to Amsterdam following the UK's withdrawal from the European Union. Clinical data relating to treatments and vaccines for COVID-19, however, continued to be published during this time on an exceptional basis to meet public demand for publication of information, facilitate global research and enhance trust in related regulatory decisions across the EU.

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