BRIEF—Nitrosamines in medicines, TGA update

Australian medicines regulator the Therapeutic Goods Administration (TGA) has published updated acceptable intake (AI) information for nitrosamine impurities in medicines consistent with recent  EMA updated information- external site.

The changes include minor editorial amendments, increases to the AI limit for a nitrosamine impurity and inclusion of recently internationally determined AI limits for numerous nitrosamine impurities in medicines.

Sponsors and manufacturers are expected to be familiar with the current acceptable intakes (AI) for nitrosamine impurities in medicines that we consider acceptable. This is detailed on the  TGA website.