Scientific Advice follow up submission

Posted Sun, 25 Oct 2020 14:13:01 GMT by Liron Gibbs-Bar Senior Regulatory and Scientific Consultant

Dear All

we would like to submit a follow up protocol to a scientific advice which took place several months ago. Is the submission deadline according to the regular scientific advice procedure deadlines published in the below link or could it be submitted at any time?

https://www.ema.europa.eu/en/human-regulatory/research-development/scientific-advice-protocol-assistance/scientific-advice-protocol-assistance-regulatory-procedural-guidance

Thank you,
Liron

Answer

Posted Mon, 26 Oct 2020 10:37:21 GMT by Paolo Tomasi EMA

You can submit an application through IRIS at any time

Posted Mon, 26 Oct 2020 11:17:04 GMT by Liron Gibbs-Bar Senior Regulatory and Scientific Consultant

Thank you!
as a follow up question - will the follow up submission be reviewed immediately following (or close to) submission via IRIS or will it be reviewed according to the CHMP timeline for scientific advice?

Best regards,
Liron

Answer

Posted Wed, 28 Oct 2020 10:53:46 GMT by Paolo Tomasi EMA

Submissions are evaluated according to the SAWP timeline, which you can find in the two documents with the 2020 and 2021 deadlines and timelines in this page.