Fig. 4

Dynamic cycle of risk management planning, Janssen algorithms inserted. Figure modified from [2, 12]. Note: RMPs are to be reviewed and updated throughout the life cycle of the product [2, 3, 12]. RMP updates may be triggered by the following [2, 3, 12, 15]: • HA or EMA request; • an application involving a change to the existing marketing authorization (e.g., new or significant indication change, new dosage form, new route of administration, or new manufacturing process of a biotechnologically derived product); • new data (including PSUR data) leading to a change in the list of safety concerns or addition of a new or a significant change to an existing additional PV activity or risk minimization measure, including the removal of a PV activity or risk minimization measure; • renewal of the marketing authorization. B-R, benefit-risk; HA, health authority; IIR, Important Identified Risk; IPR, Important Potential Risk; MI, Missing Information; PRAC, Pharmacovigilance Risk Assessment Committee; PSURs, Periodic Safety Update Reports; PV, pharmacovigilance; RMPs, Risk Management Plans