Risk management plans for medicines and biologicals

About this guidance

This guidance is for sponsors of prescription medicines and biologicals making applications to enter or vary Australian Register of Therapeutic Goods (ARTG) entries. It describes the risk management plan (RMP) requirements.

This guidance:

• describes what an RMP is
• 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 and generics
• outlines how we evaluate RMPs
• explains when to submit RMP updates after regulatory approval, and
• describes how we monitor your compliance with RMP commitments.

The RMP documents the risk management system required to; identify, characterise and minimise a product's important risks.

The TGA (we) require RMPs be submitted for evaluation with certain higher-risk applications to enter a medicine or biological in the ARTG or to vary an ARTG entry (see When an RMP is required).

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

You, as the sponsor, 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, and
• communicating this information to us in a timely manner

Further information

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

• Mandatory requirements for an effective application
• CTD module 1: Administrative information and prescribing information for Australia
• Pharmacovigilance responsibilities of medicines sponsors: Australian recommendations and requirements
• Biovigilance responsibilities of biologicals sponsors: Australian requirements and recommendations
• Template for the Australia-specific annex to the risk management plan
• Biosimilar medicines regulation

The following TGA-adopted EU guidelines are relevant:

• 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/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:

• Practical approaches to risk minimisation for medicinal products - Report of CIOMS Working Group IX

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

How to access a pdf document

• EMEA/149995/2008 Guideline on safety and efficacy follow-up - risk management of advanced therapy medicinal products
• EMA/PRAC/613102 (pdf,493kb) 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