Regulatory Open Forum

 View Only
  • 1.  Clinical trial application fees under the EU CTR

    This message was posted by a user wishing to remain anonymous
    Posted 07-Oct-2021 10:55
    This message was posted by a user wishing to remain anonymous

    Hi Raps Community,

    Currently we pay national cta fees under the clinical trial Directive in the EU. Will submitting a cta under the CTR via the EUPD change the current fee system come January 2022?


  • 2.  RE: Clinical trial application fees under the EU CTR

    This message was posted by a user wishing to remain anonymous
    Posted 12-Oct-2021 16:54
    This message was posted by a user wishing to remain anonymous

    Hi Everyone, 

    I reached out to EMA's dedicated email for Sponsors and they confirmed there are no changes to the current fee structure for clinical trials in the EU under the CTR (in case anyone saw this and had the same question). The application of a fee still remains a national decision.