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Risk management plans for medicines and biologicals
Australian requirements and recommendations
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')
- 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)
- 'additional' (see Table 1 for examples).
In this document 'Product vigilance' is used to encompass both pharmacovigilance (for medicines) and biovigilance (for biologicals)
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
An RMP is not a substitute for other product vigilance activities. You must also fulfil the pharmacovigilance or biovigilance responsibilities, as described in:
- Pharmacovigilance responsibilities of medicine sponsors - Australian recommendations and requirements
- Biovigilance responsibilities of sponsors of biologicals - Australian requirements and recommendations.
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:
- 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.