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

RAPS

12 June 2020 - After its June meeting on Thursday, the EMA’s 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 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 will be eligible for a 90% fee reduction. EMA says that revised implementing rules addressing the new fee will be published shortly.

Read Regulatory Affairs Professional Society article

Michael Wonder

Posted by:

Michael Wonder

Posted in:

Medicine , Europe , Regulation , COVID-19