Nitrosomine Risk Management Implementation Dates
Current EMA regulation dictates what manufacturers must do to remain compliant with Nitrosomine guidelines. Previous deadlines include:
31st March 2021
Step 1 − Risk evaluation for Chemical medicines
1st July 2021
Step 1 − Risk evaluation for Biological medicines
26th September 2022
Step 2 − Confirmatory testing for Chemical medicines
1st July 2023
Step 3 − Update marketing authorisations for Biological medicines
1st October 2023
Step 3 − Update marketing authorisations for Chemical medicines
Post-Deadline Compliance
Step 4 – Ongoing compliance is mandatory in your manufacturing enterprise. The EMA continues to update its Q&A and AI appendix with the most recent revision occurring in 2025. Contact us for support updating your dossiers if:
- A new nitrosomine is found during routine confirmatory testing and/or during changes to manufacturing
- An AI limit has changed according to Appendix 1 for Article 5(3) of Regulation (EC) (No) 726/2004 for Nitrosamine Impurities in Human Medicinal Products
- Your product’s shelf-life or storage conditions are modified
You can check Tox by Design methodology for Nitrosamine Impurities Assessment report, which are duly validated and signed by an European Registered Toxicologist expert.
In the event you are performing this exercise for innovative compounds GMP scale up manufacturing, please be noted that Tox by Design is duly accredited for the French Research Tax Credit CIR.
Feel free to contact us using the Quotation Request below to receive a quotation for Nitrosamine Impurities Assessment report for your Drug products.