V.B.11. The relationship between the risk management plan and the periodic safety update report

The primary post-authorisation pharmacovigilance documents for safety surveillance are the RMP and the PSUR. Although there is some overlap between the documents, the main objectives of the two are different and the situations when they are required are not always the same. Regarding objectives, the main purpose of the PSUR is retrospective, integrated, post-authorisation risk-benefit assessment whilst that of the RMP is prospective pre-and post-authorisation risk-benefit management and planning. As such, the two documents are complementary.

When a PSUR and an RMP are submitted together, the RMP should reflect the conclusions of the accompanying PSUR. For example if a new signal is discussed in the PSUR and the PSUR concludes that this is an important identified or important potential risk to be added in the RMP, the important risk can be added in the updated RMP submitted with the PSUR. The pharmacovigilance plan and the risk minimisation plan should be updated to reflect the marketing authorisation holder’s proposals to further investigate the safety concern and minimise the risk.

Table V.4. Periodic safety update report and risk management plan modules containing similar information (however, may not be in identical format and may not be interchangeable)