Brief

On 30/04/2025, the Therapeutic Goods Administration (TGA) issued an update regarding "Nitrosamine impurities in medicines". The TGA has published updated information on nitrosamine impurities consistent with recent EMA updates. This includes minor editorial amendments and internationally determined acceptable intake limits for various nitrosamine impurities in medicines. Sponsors and manufacturers are expected to be familiar with the current accepted intake limits for these impurities.

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Therapeutic Goods Administration (TGA)

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