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Nitrosamine Impurities: Deadlines & Updates In EU, US, Canada, Malaysia & Australia

 
• By Neena Brizmohun

Deadlines are nearing for drug companies to meet regulatory requirements relating to any nitrosamine impurities found in their products. Meanwhile guidelines are being revised or newly published.

policy tightening
Drug companies are required to check their products for nitrosamine impurities • Source: Shutterstock

Regulators in the EU, the US, Canada, Malaysia and Australia have each issued new or updated guidelines and statements over the past weeks on how companies can identify and, if necessary, mitigate the risk of the presence of nitrosamine impurities in drug products on the market.

Key Takeaways

  • The European Medicines Agency has published two methods for establishing acceptable intakes (AIs) for nitrosamines.
  • The US Food and Drug Administration is exploring how to identify, assess and control nitrosamine drug substance-related impurities (NDSRIs), which are a class of nitrosamines sharing structural similarity to the active pharmaceutical ingredient

The EU, US and Canadian guidelines come as deadlines near in these regions for companies to make regulatory

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