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Risk management plans for medicines and biologicals

Australian requirements and recommendations

29 March 2019

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What is an RMP?

An RMP is a detailed description of a risk management system. The RMP contains:

  • the identification or characterisation of the safety profile of the medicine or biological, with emphasis on;
    • important identified risks
    • important potential risks
    • missing information
    • which safety concerns need to be managed proactively or further studied (the 'safety specification')

and

  • a set of product vigilance and risk minimisation activities designed to identify, characterise, and manage the important safety concerns relating to the medicine or biological, including the assessment of the effectiveness of these activities and interventions.

These activities may be classified as:

  • 'routine' (which apply to all products)

or

  • 'additional' (see Table 1 for examples).

In this document 'Product vigilance' is used to encompass both pharmacovigilance (for medicines) and biovigilance (for biologicals)

Table 1: Examples of routine and additional product vigilance and risk minimisation activities
Routine Additional
Product vigilance
  • Collection, follow-up and reporting of adverse events
  • Continuous monitoring od the benefit-risk profile
  • Clinical trials
  • Post-authorisation safety studies
  • Patient registries
Risk minimisation
  • Product Information
  • Consumer Medicine Information
  • Pack size
  • Packaging and labelling
  • Medicine scheduling
  • Educational programs or tools for health professionals and/or consumers
  • Controlled access programs
  • Pregnancy prevention programs
  • Direct healthcare professional communication

The RMP covers the life cycle of the product. You must update the RMP as new knowledge and understanding of the products' safety profile and benefit–risk balance become known.

You should refer to the following EMA guidelines for information about the principles of risk management and the content of risk management plans.

  • EMA/838713/2011 Guideline on good pharmacovigilance practices (GVP) Module V - Risk management systems
  • EMA/204715/2012 Guideline on good pharmacovigilance practices (GVP) Module XVI - Risk minimisation measures: selection of tools and effectiveness indicators
  • EMA/PRAC/613102 (pdf,493kb) Guidance on the format of the risk management plan (RMP) in the EU - in integrated format

How to access a pdf document

An RMP is not a substitute for other product vigilance activities. You must also fulfil the pharmacovigilance or biovigilance responsibilities, as described in:

Why RMPs are required

A medicine or biological is approved for registration or inclusion in the ARTG if the benefit–risk balance is favourable for the target population in the specified indication(s), at the time of approval.

All products have possible safety concerns, with varying degrees of:

  • severity
  • likelihood of occurrence
  • impact on the individual patient
  • impact on public health.

Some adverse reactions and risks are not known at the time of approval (because of the limited duration, size and diversity of the patient population included in clinical trials) and will only be identified and characterised during post-approval use.

An RMP describes how safety concerns will be characterised, monitored and mitigated once the product is supplied. This helps ensure that the benefit–risk balance remains favourable or identifies if the benefits no longer outweigh the risks.

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