Sponsors need to be aware of the global issue relating to nitrosamine impurities in medicines. In particular, they should be familiar with the known and plausible causes of nitrosamine impurities in their products, and take active steps to determine whether their medicines are at risk of containing nitrosamine impurities.
Sponsors should consider the TGA’s guidance on nitrosamine impurities in medicines when preparing Category 1 prescription medicine registration applications for medicines. The guidance lists the established Acceptable Intake (AI) limits for nitrosamine impurities to date. Sponsors should refer to this information to assist them to meet their regulatory obligations…
