27 February 2024

Swissmedic: Updated requirements for dealing with potential nitrosamine impurities in medicinal products

At the end of January 2024 Swissmedic updated its Q&A document Update of the requirements for dealing with nitrosamine impurities in medicinal products. The document, now available on the Swissmedic website, features changes to the text indicated in red.

The updates include revised risk assessment guidelines for MAHs/Applicants, emphasizing the need to control nitrosamine presence in medicinal products, especially those containing chemically synthesized APIs, and confirming that acceptable nitrosamine levels in generic products align with those of the originator.

MAHs/Applicants must submit risk assessments for those medicinal products containing chemically synthesized APIs, including the assessment of NDSRIs (Nitrosamine Drug Substance-Related Impurities). Confirmatory testing is expected for marketed products with potential N-Nitroso derivatives of the API of CPCA Cat.1 or 2. If experimental evidence suggests the unlikelihood of N-Nitroso derivatives formation, contacting Swissmedic for clarification on the necessity of analytical data may be required.

Additionally, general information regarding the risk assessment for NDSRIs is provided on the Swissmedic website. Substances with the potential to form NDSRIs of CPCA categories 1 and 2 must be identified by the end of January 2024, and authorization holders are mandated to analyze these substances and report the results to Swissmedic by September 2024.