Australia – TGA Overhauls Guidance on Risk Management Plans for Medicines and Biologicals

Australia’s Therapeutic Goods Administration (TGA) has overhauled its guidance on risk management plans (RMPs) for medicines and biologicals. The guidance features significant changes to sections on the RMP format, updating RMPs, periodic safety update reports (PSURs) and other topics.

TGA brought version 3.1 of the guidance into force in November 2017. A revised version was released for a targeted external consultation one year ago, leading to the publication of version 3.3 this week.

The latest guidance is significantly different from version 3.1. In the preapproval section of the guide, TGA has added a section on RMPs for generics. Many of the RMP requirements for manufacturers of generics overlap with those of other companies, but there are some differences.

Notably, TGA wants generics companies to align their summaries of safety concerns with those of the manufacturers of the originator products. This will entail looking at sources such as the Australian Public Assessment Report and its European equivalent. TGA also expects generics manufacturers to consider whether their product introduces new safety concerns, such as the potential for medication errors arising from the use of a different administration device…