EMA to require clinical data publication for COVID-19 related products

Regulatory NewsRegulatory News | 16 September 2020 |  By 

The European Medicines Agency (EMA) this week announced it will require drugmakers to publish clinical data for medicines and vaccines authorized to treat or prevent coronavirus disease (COVID-19) as part of its exceptional transparency measures during the pandemic.
After spending years implanting its policy for proactively publishing clinical data for products submitted to the agency for review, EMA suspended the publication requirement in August 2018 to focus on its relocation from London to Amsterdam as part of its Brexit business continuity plan.
However, after facing calls from Germany’s Institute for Quality and Efficiency in Health Care (IQWiG) and the Cochrane Collaboration for the agency to reinstate the requirement for COVID-19-related products, EMA now says it will require clinical data to be published after marketing authorization. (RELATED: EMA weighs COVID-19 data transparency, not ready to resume full clinical data publication, Regulatory Focus 1 June 2020).
“The suspension of clinical data publication does not apply to COVID-19 related products, in line with EMA’s exceptional transparency measures for treatments and vaccines for COVID-19. Pharmaceutical companies should contact EMA as soon as possible concerning publication of clinical data if they plan to submit an application for a COVID-19 related product,” EMA says.
For medicines unrelated to COVID-19, EMA says the publication requirement remains suspended, “Until further notice.”


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Tags: coronavirus, EMA

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