Risk management plans for medicines and biologicals

12 December 2017

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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.

This guidance is for sponsors of prescription medicines and biologicals making applications to enter or vary ARTG entries.

A risk management plan (RMP) documents the risk management system required to identify, characterise and minimise a product’s important risks. The TGA requires RMPs to be submitted for evaluation with certain higher-risk applications to enter a medicine or biological in the Australian Register of Therapeutic Goods (ARTG) or to vary an ARTG entry (see When an RMP is required).

RMPs must be maintained throughout the lifecycle of the product and important updates submitted to the TGA for evaluation (see Submitting RMP updates after regulatory approval).

As a sponsor, you are responsible for the RMP, including:

  • developing the RMP
  • updating the RMP as new safety information emerges
  • implementing the activities and interventions outlined in the RMP
  • collecting and analysing information to monitor the effectiveness of these activities and interventions
  • communicating RMP changes to the TGA in a timely manner

About this guidance

This guidance:

  • explains when you must submit an RMP with an application for registration, inclusion or variation in the ARTG
  • describes what to include in an RMP and the required format for RMPs
  • details special requirements for RMPs for biologicals
  • outlines how the TGA evaluates RMPs
  • explains when to submit RMP updates after regulatory approval
  • describes how the TGA monitors sponsor compliance with RMP commitments

As part of the Australian Government MMDR reforms, TGA will be consulting on version 4.0 of this guidance in early 2018.

Further information

For further information about risk management plans, see the following TGA guidance:

The following TGA-adopted EU guidelines are relevant:

  • EMA/838713/2011 Guideline on good pharmacovigilance practices (GVP) Module V - Risk management systems
  • EMA/488220/2012 Guideline on good pharmacovigilance practices (GVP) Product- or Population-Specific Considerations I: Vaccines for prophylaxis against infectious diseases
  • EMEA/359381/2009 CHMP Recommendations for the Pharmacovigilance Plan as part of the Risk Management Plan to be submitted with the Marketing Authorisation Application for a Pandemic Influenza Vaccine

Useful publication:

The following EU guidelines have not been adopted by the TGA at the moment, but are also relevant to RMPs:

  • EMEA/149995/2008 Guideline on safety and efficacy follow-up - risk management of advanced therapy medicinal products
  • EMA/204715 Guideline on good pharmacovigilance practices - Module XVI– Risk minimisation measures: selection of tools and effectiveness indicators
  • EMA/PRAC/613102 Guidance on the format of the risk management plan (RMP) in the EU - in integrated format
  • EMA/PRAC/222346 Interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU

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