The European Medicines Agency just announced yet another extension for the testing of Nitrosamines contamination.
The Step 1 risk evaluation for products containing chemically synthesised APIs should now be concluded and reported by 31st March 2021, and for those containing biological APIs, by 1st July 2021.
As per the previous guidance, all MAHs should inform the concerned Competent Authorities within their own country of the outcome of their risk evaluation using the dedicated portal where it exists, or via the dedicated templates available on the EMA website.
Furthermore, the Step 2 confirmatory testing for products containing chemically synthesised APIs are expected to be finalized at the latest by 26th September 2022 and for products containing biological APIs, by 1st July 2023.
The extension certainly relieves a little pressure on the pharma industry, but there is no guarantee of further extensions, so it's advisable to act now.
Visit our Nitrosamines overview page to find out more, and discover why QUINTA-ANALYTICA have become european leaders in the field of nitros detection.
August 11, 2020