Appendix 1 – Established Acceptable Intake for Nitrosamines in Medicines

The document provides information about the regulation and monitoring of nitrosamines in therapeutic goods. Nitrosamines are chemical compounds that can be potentially carcinogenic, and their presence in medications has raised safety concerns globally.

Key Points
1. Nitrosamine Contamination
Nitrosamines are known to be harmful and have been found in certain medications, leading to recalls and safety alerts.
Contamination can occur during the manufacturing process or from the raw materials used.
2. Regulatory Measures
The TGA has implemented strict regulations and monitoring processes to ensure the safety of therapeutic goods.
Manufacturers are required to assess and control nitrosamine levels in their products.
The TGA works in collaboration with other regulatory agencies and industry stakeholders to manage and mitigate risks associated with nitrosamines.
3. Safety Alerts and Recalls
The document outlines procedures for issuing safety alerts and managing recalls when nitrosamines are detected in products.
It provides guidance on how the public and healthcare professionals can stay informed about these alerts.
4. Industry Responsibilities
Pharmaceutical companies must conduct risk assessments and implement measures to minimize nitrosamine contamination.
They are also required to report any findings of nitrosamines and cooperate with regulatory actions.
5. Ongoing Monitoring and Updates
The TGA continues to monitor the situation and update its guidelines based on new information and research.
The document emphasizes the importance of vigilance and continuous improvement in safety practices.
6. Public Health Impact
The TGA’s actions aim to protect public health by ensuring that therapeutic goods are free from harmful levels of nitrosamines.
The document provides reassurance that the regulatory framework is in place to address any potential risks.
The TGA’s approach is part of a broader global effort to manage nitrosamine contamination and ensure the safety of medicines and therapeutic products. The document emphasizes transparency, industry collaboration, and ongoing vigilance in maintaining high safety standards.

Source: https://www.tga.gov.au/how-we-regulate/monitoring-safety-and-shortages/industry-information-about-specific-safety-alerts-recalls-and-shortages/nitrosamine-impurities-medicines/appendix-1-established-acceptable-intake-nitrosamines-medicines##~https://www.tga.gov.au/sites/default/files/2023-08/appendix-1-established-acceptable-intake-nitrosamines-medicines.pdf

Region: Australia