GERMANY'S HTA AGENCY SEEKS SUPPORT ON TRANSPARENCY ABOUT COVID-19 AGENTS

ABSTRACT

"EMA should support the international research community by publishing clinical study reports on medicine and vaccine trials at the time of marketing authorization and to inform treatment decisions." [...]Weiseler and Kaiser are acutely aware of the pressures that regulators are under in the face of a rising death toll, soaring infection and morbidity, and the wideranging economic and social consequences of extensive lock-downs. "Because of the severity of the current situation, regulators are aiming to accelerate the marketing authorization process," IQWiG comments, noting that first treatments have already been evaluated by regulators, as recently seen with the fast emergency use authorization of the antiviral remdesivir by the FDA, and that EMA has also started a "rolling review" of remdesivir. Data-sharing push The international research community is already undertaking coordinated efforts- IQWiG cites the living mapping and living systematic review of COVID-19 studies-to compile all emerging information on medicines and vaccines for the virus, it says, with a view to ensuring the optimal planning and conduct of research.