9/10 February 2023
Following the publication of the Assessment Report "Nitrosamine impurities in human medicinal products" by the CHMP on 9 July 2020, the decision was made to directly apply the recommendations on the management of nitrosamine impurities outlined in this report to sartan preparations (angiotensin II receptor antagonists with a tetrazole ring). The EMA provided information on this in a news article released on 13 November 2020. The following sartan APIs are involved:
The "final assessment report" for these 5 sartan preparations, published at the end of February 2021, includes requirements regarding the control of nitrosamine impurities as well as notification deadlines relevant to marketing authorisation.
The European Pharmacopoeia Commission then initiated a rapid revision procedure to ensure that the information on these sartan preparations in the pharmacopoeia is in line with current regulatory requirements. The monographs for these sartans have been revised accordingly, with the respective following changes:
In the course of this revision decision, two other General Monographs of the European Pharmacopoeia were also updated (but not within the rapid revision procedure):
In these monographs, guidance on risk assessment regarding nitrosamine impurities in APIs and medicinal products has been included. These monographs are published in Pharmeuropa 33.2.