Table 2.
Data extraction methodology for different EU-RMP formats
| Type of information | Location of the information in EU-RMP format Aa | Location of the information in EU-RMP format Bb | Location of the information in EU-RMP format Cc |
|---|---|---|---|
| Safety concerns (IIR, IPR, MI) | RMP part II, module SVIII “Summary of the safety concerns” | RMP Section 1. Safety Specification: Subsection 1.10 “Summary – Ongoing safety concerns” | RMP Section 2 Safety Specification Subsections: “Summary on Pre-clinical Safety” and “Summary of Clinical Safety” |
| Sources associated with the inclusion, removal and reclassification of the safety concerns | RMP part II, module SVII “Identified and potential risks” |
RMP Section 1 Safety Specification: Subsection 1.5.1 “Newly identified safety concerns” and Subsection 1.5.2 “Details of important identified and potential risks” |
RMP Section 2 Safety Specification Sub-sections: “Summary on Pre-clinical Safety” and “Summary of Clinical Safety” |
| Routine and additional PV activities | RMP part III “Pharmacovigilance plan (including post-authorisation safety studies)” | RMP Section 2 “Pharmacovigilance Plan” | RMP Section 3 “Pharmacovigilance plan” |
| Routine and additional RM measures | V “Risk minimisation measures (including evaluation of the effectiveness of risk minimisation activities)” | RMP Section 5. “Risk Minimisation Plan” | RMP Section 5 “The Risk Minimisation Action Plan” |
EU-RMP European Risk Management Plan, IIR important identified risk, IPR important potential risk, MI missing information, PV pharmacovigilance, RM risk minimisation
aEU-RMPs dated from July 2012 to October 2020 following the guidance on the format of the risk management plan (RMP) in the EU [6, 10, 18]
bEU-RMPs dated between 2005 to 2012 following to the “Guideline on Risk Management Systems for Medicinal Products for Human Use” [3] and Annex C: TEMPLATE FOR EU RISK MANAGEMENT PLAN (EU-RMP) [3, 4]
c“EMEA/192632/2006, Annex C: EU-RMP Template” [4] was not available at the time of submission of Product B EU-RMP version 1.0 (February 2006) and hence, Product B EU-RMP version 1.0 was prepared in a different format