Feedback on EMA draft toolbox guidance for PRIME marketing authorisation applications

Regulatory Strategy members participated in a series of meetings to review EMA Toolbox guidance on scientific elements and regulatory tools to support quality data packages for PRIME marketing authorisation applications which was published for public consultation February 2021.

A summary document detailing consolidated feedback and suggested recommendations that represented the views of member companies was submitted to the EMA in July 2021

This document is reserved for the use of BioPhorum members only.

I don't have access to this document

Make a selection below and submit your request. We will get back to you ASAP.

My company would like to become a member

If you're not sure if your company is a member of this Phorum, or if you would like to enquire on behalf of your company about becoming a member, please see our membership page.