---
title: "Nitrosamines Update EMA/409815/2020 Rev.24"
description: "EMA published Rev. 24 of its nitrosamine Q&A on 3 November 2026, adding Q&As on other N-nitroso structures and Less-Than-Lifetime (LTL) adjustment."
url: https://qbdgroup.com/en/regulatory-updates/ema-nitrosamines-qa-rev24
type: "Regulatory update"
language: en
published: 2026-11-06
author: "Pablo Palomar"
category: "Regulatory Update"
publisher: "QbD Group"
citation: "QbD Group, \"Nitrosamines Update EMA/409815/2020 Rev.24\", https://qbdgroup.com/en/regulatory-updates/ema-nitrosamines-qa-rev24"
---
# Nitrosamines Update EMA/409815/2020 Rev.24
> EMA published Rev. 24 of its nitrosamine Q&A on 3 November 2026, adding Q&As on other N-nitroso structures and Less-Than-Lifetime (LTL) adjustment.

On 3 November 2026, the European Medicines Agency (EMA) released an update to the guideline *Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products* (EMA/409815/2020 Rev.24).

## What’s New?

The update mainly introduces two new Q&As, 23 and 24.

- Q&A 23 states that other N-nitroso structures that are not specifically nitrosamines should now follow the same principles to establish acceptable intakes (use of compound-specific carcinogenicity data or read-across to a robust surrogate). However, the CPCA remains unavailable for establishing acceptable intakes for these structures.
- Q&A 24 describes new indications for applying the Less-Than-Lifetime (LTL) adjustment, in alignment with the recent FDA recommendations on nitrosamines (September 24, 2026: *Application of Less-Than-Lifetime Adjustment to Nitrosamine Impurities*).

In addition, other clarifications have been added across the document, such as nitrosamine contamination from polymer bags in parenteral products (Q&A 4) and guidance on establishing acceptable intake (AI) limits for nitrosamines arising from excipients (Q&A 10).

## What Does This Mean for You?

This update is particularly relevant for products where a risk has been identified and the use of LTL has been agreed with regulatory authorities. We therefore recommend reviewing all products that have presented a risk and determining whether the new principles for applying LTL are applicable.

You should also review the established limits for cases where the risk stems from an excipient, and verify that the MDD data has been used correctly.

A thorough review is also required for parenteral products packaged in polymer bags, as cases of nitrosamine formation from amines and nitrosating agents present in packaging components, such as monomers, plastic additives and printing inks, have been reported.

## Staying Ahead of the Curve

This update is a clear example of how nitrosamine regulations are constantly evolving in line with the latest reports and the scientific knowledge being gained globally. Staying up to date with all changes is therefore essential to ensuring patient safety across all pharmaceutical products.

## How Can QbD Group Assist You?

Our team of expert toxicologists can support you through regulatory changes and ensure your Nitrosamine Risk Assessments are accurate, compliant, and up to date.
---
Source: https://qbdgroup.com/en/regulatory-updates/ema-nitrosamines-qa-rev24 — © QbD Group. Quote freely with attribution and a link back.