Nitrosamine impurities acceptable intakes update – October 2024

News Healthcare & Pharma Guidance

Date: 16th Oct, 2024 Source: Therapeutic Goods Administration (TGA) Country: Australia Original Source

Brief

On "16/10/2024", the "Therapeutic Goods Administration (TGA)" issued an update regarding Nitrosamine impurities acceptable intakes update - October 2024. The TGA published updated information consistent with recent EMA updates, clarifying expectations for sponsors and manufacturers. Minor editorial amendments were also made to increase AI limits for some nitrosamines in medicines.

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Therapeutic Goods Administration (TGA)

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Nitrosamine impurities acceptable intakes update – October 2024

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Nitrosamine impurities acceptable intakes update – October 2024

Brief

Therapeutic Goods Administration (TGA)

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