21 Jan 2020

Nitrosamines – Risk evaluation

Written by

César Gonçalves

Managing Director

At the end of September EMA began a review under the Article 5(3) of Regulation (EC) No 726/2004 to provide guidance for MAHs on how to avoid nitrosamines in human medicines.

For Step 1, MAHs were requested to perform a risk evaluation of the presence of nitrosamine impurities in human medicinal products containing chemically synthesized active pharmaceutical ingredients. The outcome of the analysis should be reported until the 26th of March 2020.

We can help you accomplish Step 1 through our Nitrosamine Risk Evaluation Tool, which includes: - Risk Assessment protocol – for project definition; - Queries – for collecting information; - Risk Matrix – for risk assessment; - Risk Evaluation Table – for result display.

With this tool, MAHs will be able to prioritize their products and evaluate the risk of presence of nitrosamines, defining the strategy for step 2.

Contact us for more details.