EMA soon to publish updated guidance on Nitrosamine Impurities

The EMA’s human medicines committee (CHMP) has now issued an opinion regarding the maximum limits of  nitrosamines in medicines and the measures required by pharmaceutical companies to reduce the presence of these carcinogenic impurities.

As captured in our 2019 posts regarding nitrosamines and the considerations for marketing authorisation holders, due to the number of possible sources for nitrosamine formation in medicines, all marketing authorisation holders containing chemically synthesised active substances have been required to conduct a review into their products.

Detailed guidance for companies, which is shortly to be published by the EMA, has been put together using lessons drawn from an investigation into the sartan blood pressure medicines. The guidance is expected to include limits for nitrosamines based on lifetime exposure and instructions to companies to evaluate the risk of these impurities being present in medicines and carry out appropriate tests if a risk is identified.

Here at JensonR+, we will be continuing to monitor the situation in 2020 and beyond, so follow us on LinkedIn to receive any updates. If you would like to discuss the potential impact of this change to your products, then please do not hesitate to contact us at consultancy@jensongroup.com.

Ben Smith