TGA Australia publishes updated guidance on risk management plans for medicines and biologicals

The Therapeutic Goods Administration (TGA) Australia has published revised guidance on risk management plans (RMPs) for medicines and biologicals. The guidance is for sponsors of prescription medicines and biologicals making applications to enter or vary an Australian Register of Therapeutic Goods (ARTG).

An RMP records the risk management system required to identify, characterise and minimise a product’s key risks. RMPs should be submitted for evaluation with certain higher-risk applications to enter a medicine or biological in the ARTG or to vary an ARTG entry. It is important to maintain RMPs throughout the lifecycle of the product and any important updates should be submitted to the TGA for evaluation.

Sponsors have several responsibilities regarding the RMP, including: developing the RMP; updating the RMP as new safety information emerges; implementing the interventions and activities outlined in the RMP; collecting and analysing information to monitor the effectiveness and communicate RMP changes to the TGA.

The following is explained in the guidance:

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

As part of the Australian Government Medicines and Medical Devices Regulation reforms, TGA will be working on version 4.0 of this guidance in early 2018.

To view the TGA guidance on risk management plans, please click here.