Brief

On 09/12/2024, the Therapeutic Goods Administration (TGA) issued an update regarding Automatic extension of Mutual Recognition Agreement (MRA) Good Manufacturing Practice (GMP) clearances. The TGA announced that GMP Clearances issued via the MRA pathway expiring on 31 December 2024 will be automatically extended until 31 December 2025 due to ongoing delays in inspection frequencies. This eliminates the need for sponsors to submit an extension application.

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Therapeutic Goods Administration (TGA)

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