In 2018, the European medicines regulatory network became aware of the presence of N-nitrosamines in sartan APIs and instituted a series of regulatory actions across the EU, including recalls of some medicines and measures to prohibit the use of APIs from certain manufacturers. The case raised a number of important issues leading to a lessons learnt exercise to consider ways to prevent unexpected impurities such as N-nitrosamines from being present in human medicines and to better manage such cases should they occur in the future.
In June of this year the EMA posted a document detailing the lessons learnt from this incident and made recommendations to reduce the potential of these and other impurities being present in human medicines.
Recommendations include several revisions or clarifications of guidelines, as well as possible changes to legislation during implementation. CHMP is due to issue further detailed information, where companies will be required to have appropriate control strategies to prevent or limit the presence of these impurities and, where necessary, improve their manufacturing processes. Companies will also have to evaluate the risk of nitrosamines being present in medicines and carry out appropriate tests if a risk is identified.
Provided here is a summary of the 98 page lessons learnt document, with specific focus on regulatory implications. Watch this space for support and guidance from the Kinapse team in 2020 and beyond.
Use the button below to download the PDF and learn more.