Nitrosamine risk assessment in Category 1 prescription medicine registration applications

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.

Sponsors should also provide a nitrosamine risk assessment, or a scientific justification for not providing this information, in the dossier for Category 1 prescription medicine registration applications for their medicines. If a risk is identified, then the sponsor is expected to conduct confirmatory testing for their products and provide this data. The inclusion of this information will be noted at preliminary assessment. If this information is not provided, the TGA will request further information regarding the required risk assessment before a preliminary assessment decision is made.

Contact the TGA:

• For questions regarding Category 1 prescription medicine applications please email us at streamlinedsubmission@health.gov.au.