TGA published new guidance for nitrosamine risk assessment on 7 October 2025.
https://www.tga.gov.au/resources/guidance/understanding-nitrosamine-risk-listed-medicines
Purpose
This page provides information for sponsors (product owners) and manufacturers of listed medicines and other parties involved in the medicine supply chain, such as ingredient suppliers.
Our intent is to raise awareness of the potential for nitrosamine impurities to form in certain listed medicine ingredients and formulated finished products containing such ingredients and provide information on how to assess the likelihood of susceptible ingredients forming nitrosamine impurities.
This advice aligns with the principles set out in the TGA publication Nitrosamine impurities in medicines but has been tailored to suit the unique environment of listed medicines.
For the purposes of this advice, the term ‘susceptible ingredient(s)’ refers to a discrete chemical entity (e.g. a vitamin) used in listed medicines that contains an amine functional group, as outlined in the section below, ‘How nitrosamine impurities form.’
Notably, complex botanical ingredients (such as plant extracts) and ingredients derived from natural sources are excluded from this advice. These may be addressed in future publications concerning nitrosamine and nitroso impurities in listed medicines. This information will be updated as new information becomes available.
Listed medicines stakeholders should regularly visit https://www.tga.gov.au/how-we-regulate/monitoring-safety-and-shortages/industry-information-about-specific-safety-alerts-recalls-and-shortages/nitrosamine-impurities-medicines and the TGA website to remain current with developments regarding nitrosamine impurities in medicines.