Risk management plans
Where stated, "RMP" refers to the RMP format requested by the TGA. This typically comprises both the EU RMP and an Australian Specific Annex (ASA). For more information, see RMP format.
Since April 2009, the TGA has required Risk Management Plans (RMP) be submitted for all:
- new chemical entities (i.e. a substance / product not currently entered in the ARTG)
- registered products:
- when there is a major change in the way in which the product is used or
- if a new safety concern is identified with an existing product.
The requirements are set out in the Mandatory requirements for an effective application - CTD module 1: Administrative information and prescribing information for Australia.
- All sponsors must comply with the requirements set out in the Australian pharmacovigilance requirements and recommendations for medicines sponsors.
- For submissions involving biosimilars, refer to the TGA guideline: Evaluation of biosimilars.
What is an RMP?
An RMP is a detailed description of a risk management system. The RMP essentially contains:
- A description and analysis of the safety profile of the medicine including a summary of the safety concerns; and
- A set of pharmacovigilance and risk minimisation activities designed to identify, characterise and manage risks relating to the medicine including the assessment of the effectiveness of these activities and interventions.
The RMP covers the entire life cycle of the product. Therefore, it will need to be periodically updated to reflect new knowledge and understanding of the products' safety profile and benefit risk balance.
Why have RMPs been introduced?
Limited safety information for new medicines
At the time of authorisation, information on the safety of a medicine is relatively limited. This is due to the limitations of clinical trials, including:
- relatively small numbers of subjects in clinical trials compared with the intended treatment population
- restricted population in terms of age, gender or ethnicity
- restricted co morbidity
- restricted co medication
- restricted conditions of use
- relatively short duration of exposure and follow-up
- statistical problems associated with assessing many different outcomes.
As a result, not all safety issues related to a medicine will have been identified during pre marketing studies, particularly in the case of new chemical entities, biological products, and where a sponsor applies for use in a new population, such as in children.
Maintaining the benefit-risk balance
A medicine is authorised on the basis that in the specified indication(s), at the time of authorisation, the benefit risk balance is favourable for the target population. However, not all benefits or risks will apply equally to all patients.
When considering how to maximise or assess the benefit risk balance, risks need to be understood in the context of benefit. An RMP identifies how safety concerns will be identified and mitigated once the product is supplied, to help ensure the benefit risk balance remains favourable.
|Version||Description of change||Author||Effective date|
|V1.0||Original Publication||Risk Management Plans Section/Office of Product Review||03/09/2012|
|V1.1||Updated Template||Risk Management Plans Section/Office of Product Review||05/09/2012|
|V1.2||Updated content||Risk Management Plans Section/Office of Product Review||14/09/2012|
|V1.3||Updated content||Risk Management Plans Section/Office of Product Review||03/10/2012|
|V2.0||Updated content, added Australian‐specific annex as attachment||Risk Management Plan Evaluation Section/Post-market Surveillance Branch||May 2015|
|V2.1||Updated committee names in 'Evaluation process for Risk Management Plans (prescription medicines)'||Risk Management Plan Evaluation Section/Post-market Surveillance Branch||10 April 2017|