Clinical data publication for COVID-19 related products

The European Medicines Agency (EMA) will require publication of clinical data for COVID-19 related medicines and vaccines in order to maximise the transparency of its regulatory activities.

EMA suspended the publication requirement in 2018 to focus on its relocation from London to Amsterdam, as part of its Brexit business continuity plan.

However, as part of its exceptional transparency measures during the pandemic, EMA now says it will require clinical data to be published after marketing authorisation, for all COVID-19 related treatments and preventions.

“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.”

For medicines unrelated to COVID-19, the publication requirement is still suspended until further notice.

For more detailed information on the EMA’s exceptional transparency measures, click here.