Table 3 Summary of changes in the Guideline on Good Pharmacovigilance Practices Module V (Revision 2) (including Guidance on the format of the Risk Management Plan in the European Union—in integrated format) [3, 4, 13, 14]
Safety Concern | Summary |
|---|---|
IIRs | Impact on RMP Planning |
The RMP should address only those IIRs which are undesirable clinical outcomes. An IIR to be included in the RMP would usually require: • Further evaluation/characterization as part of the PV Plan • RMMs: such as product information advising on specific clinical actions to be taken to minimize the risk or additional RMMs) | |
Considerations for Removal | |
An IIR may be removed from the RMP where: • Fully characterized, with no outstanding additional PV activities • Appropriately managed, with no ongoing additional RMMs and where any RMMs recommending specific clinical measures have become fully integrated into standard clinical practice | |
IPRs | Impact on RMP Planning |
The RMP should address only those IPRs which are undesirable clinical outcomes. An undesirable clinical outcome associated with off-label use or an area of MI may be included as an IPR if deemed important and supported by a scientific rationale An IPR to be included in the RMP would usually require: • Further evaluation/characterization as part of the PV Plan | |
Considerations for Removal | |
An IPR may be reclassified or removed from the RMP where: • Scientific and clinical data strengthen evidence of a causal association with the product [reclassification to IIR] • Accumulating scientific and clinical data do not support a causal association with the product • There is no reasonable expectation that any PV activity could further characterize the risk) | |
MI | Impact on RMP Planning |
Areas of MI included in the RMP should: • Be within the approved indication • Focus on areas where there are gaps in knowledge about the safety for certain anticipated utilization/patient populations • Be based upon a scientific rationale that anticipates the areas of MI might differ from the known safety profile MI in the RMP would usually requirea: • Further evaluation/characterization as part of the PV Plan | |
Considerations for Removal | |
An area of MI may be removed from the RMP where: • Adequate safety data are available with respect to the area of MI • There is no reasonable expectation that any PV activities could further characterize the safety profile with respect to the areas of MI |