The new guidance takes effect from the beginning of October 2018 and is available here.
So that market research agencies and marketing authorisation holders have a clear and efficient process to follow when collecting, forwarding and managing information about an adverse event (AE), product complaint (PC) or special reporting situation (SRS) that comes up during a market research project.
The Guidance is designed to help healthcare market researchers – whether working for a market research agency or a marketing authorisation holder.
Marketing authorisation holders have a legal and regulatory obligation to monitor, collect and manage AEs, PCs and SRSs for the medicines for which they are the licence holders. Events collected from market research projects feed in to pharmacovigilance systems and so have a role to play in helping the industry to monitor the efficacy and safety of the medicines it produces.
There have been three key changes to the Guidance:
The 2018 update hasn’t been without its challenges; we have worked hard to:
Consequently we would like to thank the many stakeholders from industry, regulators and professional organisations who supported the development of the 2018 update.