RQA GPvP Committee
in addition to the response already provided, we would like to refer you to the EMA's GVP Module VII – Periodic safety update report (Rev 1), where VII.B.5.11. PSUR section “Literature” states why the search for the purposes of the PSUR (and that would also apply for Risk Management Plans) should be wider than only ICSRs.
VII.B.5.11. PSUR section “Literature”
Literature searches for PSURs should be wider than those for individual adverse reaction cases as they should also include studies reporting safety outcomes in groups of subjects and other products containing the same active substance.
We hope you find this useful.