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

Regulatory NewsRegulatory News | 01 June 2020 |  By 

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 live, Regulatory Focus 20 October 2016; Brexit impact: EMA suspends publication of clinical trial data, Regulatory 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.
While welcoming EMA’s effort to accelerate the review of products, the officials wrote that, “To achieve sustainable efforts in health care, this effort must also include the publication of [clinical study reports] to make the full information on any new medicine or vaccine publicly available as soon as possible.”
In his reply, Rasi wrote that EMA’s “activities in relation to COVID-19 deserve the highest possible level of transparency and, in keeping with our commitment, the Agency will take appropriate action to share information publicly. We are currently discussing how to enhance the level of transparency for COVID-19 procedures, including the possibility of rapidly publishing clinical data for these products.”
Rasi added that the agency is still working out how to address challenges related to publishing data related to products being assessed under accelerated procedures such as rolling review, as in the case of Gilead Science’s remdesivir. (RELATED: EMA kicks off rolling review of Gilead’s remdesivir; Regulatory Focus 1 May 2020).
Rasi also said he cannot commit to when EMA will resume its proactive publication of clinical data as it did prior to its move to Amsterdam. “I can’t yet commit to reinitiate all activities related to clinical data publishing for medicines evaluated by the Agency. However, as stated above, COVID-19 related medicines deserve special consideration because of the overriding public interest and the need to support the international research community and foster the collaborative effort,” Rasi said.


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