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Brief
On 29/05/2025, the Therapeutic Goods Administration (TGA) issued an update regarding GMP Clearance: Backlog reduction strategy commencing 1 July 2025. The TGA is introducing temporary risk-based strategies to reduce the backlog of applications, including automatic extension of existing Mutual Recognition Agreement and non-sterile API CV GMP clearances, abbreviated evaluation of lower-risk manufacturers, and ending regulatory flexibilities introduced during COVID-19 pandemic, effective from 1 July 2025.
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