EMA management board backs rolling review fees, COVID-19 transparency measures

Regulatory NewsRegulatory News | 12 June 2020 |  By 

After its June meeting on Thursday, the European Medicines Agency’s (EMA) management board said it has approved a new fee for rolling reviews and that the agency will be providing more details about its approach to publishing clinical data for vaccines and drugs for coronavirus disease (COVID-19).
The new rolling review fee “would be deducted from the fee that would become due with the submission of an actual marketing authorisation application.” The specific fee amount has not been disclosed, though small- and medium-sized enterprises (SMEs) will be eligible for a 90% fee reduction. EMA says that revised implementing rules addressing the new fee will be published shortly.
According to the meeting agenda, the management board discussed “publication of all clinical summaries and reports regarding COVID-19 related and authorized drugs/vaccines,” during the virtual meeting.
The discussion came just weeks after EMA Executive Director Guido Rasi responded to a letter calling for EMA to publish all clinical study reports for products related to COVID-19 at the time of their marketing authorization. (RELATED: EMA weighs COVID-19 data transparency, not ready to resume full clinical data publication, Regulatory Focus 1 June 2020).
EMA says its management board also backed a methodology and next steps to develop a “go-live” plan for its Clinical Trials Information System required under the EU Clinical Trials Regulation.
“A group will be responsible for prioritising all outstanding issues to the CTIS governance and matching the items remaining after the audit to the capacity available before go-live and thereafter,” EMA says, adding that it is aiming for the system to go live in December 2021.
Additionally, the management board adopted EMA’s annual activity report for 2019 and a plan to implement recommendations on maintaining EMA and its committee members’ independence.
The management board also announced it will vote to elect a new EMA executive director on 25 June 2020 to replace Rasi, whose second term as executive director ends in November.


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