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Risk Management Plans and Periodic Safety Update Reports

A medicinal product (or vaccine) is authorized on the basis that the benefit-risk balance is judged to be positive for the approved indications. Generally, a medicinal product will be associated with adverse reactions, and these will vary in terms of severity, likelihood of occurrence, effect on individual patients, and public health impact. However, not all adverse reactions are risks that will have been identified when an initial marketing authorization is granted, and some will only be discovered and characterized in the post-authorization stage. (1)

The overall aim of risk management is to ensure that the benefits of a particular medicinal product exceed the risks by the greatest achievable margin for both the individual patient and the target population; in other words, to optimize the use of the drug.(2)  The fundamentals of a risk management plan are based on proactive pharmacovigilance planning, by:

  • Anticipating the risks of medicines, based on known information.

  • Identifying areas in which information is scarcer.

  • Looking to further studies to identify and/or characterize risks on more scientifically.(2)2

The main objective of a periodic safety report is to present a comprehensive, concise, and critical analysis of new or emerging information on the risks of a medicine or vaccine and on its benefits in approved indications, enabling a general risk-benefit balance assessment of the productr.3

Regulatory Authorities – Guidelines/requirements:

Publications

Risk Management Plans and Periodic Safety Reports for COVID-19 Vaccines: Recommendations for Their Request, Preparation, Management, and Assessment

This document establishes recommendations and considerations to guide the development of strategies to assess the risk management plans and periodic safety reports required for use authorization of COVID-19 vaccines and for safety monitoring once their use is authorized.

Link to publication

 

Referencias:

1.    EMA Guideline on good pharmacovigilance practices (GVP) Module V – Risk management systems (Rev 2).

2.    Red PARF Documento Técnico No. 5 Red Panamericana de Armonización de la Reglamentación Farmacéutica Grupo de Trabajo en Farmacovigilancia. Buenas Prácticas de Farmacovigilancia para las Américas Washington, DC. Diciembre del 2010.

3.    ICH HARMONISED TRIPARTITE GUIDELINE. PERIODIC BENEFIT-RISK EVALUATION REPORT (PBRER) E2C(R2). Current Step 4 version. Dated 17 December 2012.

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