15/16 October 2020
All marketing authorisation holders of medicinal products containing chemically synthesised APIs are required to submit a risk assessment of their products with regard to potential nitrosamine impurities to their competent regulatory authority by 26 March 2020 at the latest. The procedure and the deadline available to the marketing authorisation holders for this purpose are set out in EMA's document entitled "Information on nitrosamines for marketing authorisation holders (EMA/189634/2019)" dated 19 September 2019, which was published on 26 September 2019. It thus defines a time window of exactly 6 months. This measure was triggered after nitrosamine impurities were detected in chemically synthetic APIs for the first time in summer 2018 and in further cases thereafter.
The authorities reacted quickly to this situation, first and foremost the EDQM, which as an immediate measure withdrew the CEPs for the APIs affected and already published a series of analytical methods for the determination of nitrosamines in a News published on 11 October 2018.
Meanwhile the amount of information, publications, press releases, etc. on the EDQM website as well as on the EMA website has increased tremendously and thus has become quite confusing. To remedy this, the EDQM has set up a new website named "The EDQM's response to nitrosamine contamination". On this site, you will find all important information and documents published by the EDQM on nitrosamine contamination. It is divided into the following sections:
Several links on this page lead to important documents of the EMA, the EU Commission and the OMCL network, where you can find a variety of analytical methods for the determination of various nitrosamines.