Pharmacovigilance Practices Summary

Study Notes

The RMP documents the necessary risk management system to identify, characterize, and minimize a medicinal product's important risks.
Identified risks: undesirable clinical outcomes with sufficient evidence linking them to a product.
Potential risks: undesirable outcomes with suspicion of causation but insufficient evidence to confirm.
Important identified risks can impact a product’s risk-benefit balance, requiring further evaluation.
Important potential risks may become significant if further confirmed.
Missing Information refers to gaps in knowledge about the safety profile due to insufficient data for specific usages or populations.

A key objective is to ensure the benefits of a medicinal product far outweigh its risks.
RMPs are dynamic and must be updated throughout the product's life cycle.
Risk management systems should be proportional to identified and potential risks, as well as the need for post-authorization safety data.

Main parties involved: applicants/marketing authorization holders and competent authorities.
Applicants are responsible for having an effective risk management system and reviewing safety knowledge critically.
Significant reviews of safety concerns are advised at 5 years and during PSUR submissions around 8-9 years post-authorization.

The RMP consists of seven parts, following a standardized template as per regulatory guidelines.

Contains administrative details and a current product overview, including active substance information, indications, and monitoring requirements.

Describes the product's safety profile, focusing on important identified risks, potential risks, and any missing information.
Identifies populations at risk and outstanding safety questions needing investigation.
Comprises eight RMP modules aligning with ICH-E2E guidelines.

Outlines how to further understand and characterize safety concerns.
Includes investigating potential risks, and strategies for information gathering, and measuring effectiveness of risk minimization measures.

Lists any efficacy studies required as conditions for marketing authorization or under specific obligations.
If no studies are required, this section can be left blank.

Details measures to minimize risks related to safety concerns, which includes routine activities applicable to all products such as labeling and package details.

A publicly available summary that includes key RMP elements and is updated with significant RMP changes.
Must be written in clear, plain language for diverse audiences.

RMP and PSUR are complementary documents; the PSUR provides retrospective assessments while the RMP focuses on prospective risk management.

Final responsibility for RMP integrity lies with the marketing authorization holder, who must ensure updates reflect new information and maintain records of changes.

Full RMP submission is required for initial marketing authorizations, but content may vary proportionally based on identified risks.
RMPs must be submitted electronically as part of the initial marketing authorization process or through post-authorization procedures.

RMP oversight is conducted by the Pharmacovigilance Risk Assessment Committee (PRAC), which appoints rapporteurs for coordinated assessment with other relevant committees.