Europe – EMA weighs COVID-19 data transparency, not ready to resume full clinical data publication

In a response to officials at Germany’s Institute for Quality and Efficiency in Health Care (IQWiG) and the Cochrane Collaboration, European Medicines Agency (EMA) Executive Director Guido Rasi said the agency is trying to figure out how to be transparent with regard to clinical trial data for products it reviews to treat or prevent coronavirus disease (COVID-19).
After spending years implanting its policy for proactively publishing clinical data for products submitted to the agency for review, EMA suspended its publication efforts in August 2018 to focus on its relocation from London to Amsterdam as part of its Brexit business continuity plan. (RELATED: EMA transparency: New clinical reports go liveRegulatory Focus 20 October 2016; Brexit impact: EMA suspends publication of clinical trial dataRegulatory Focus 15 August 2018).
In a letter dated 14 May, the officials at IQWiG and Cochrane called for EMA to publish all clinical study reports for medicine and vaccines for COVID-19 at the time of their marketing authorization…