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news

News from the world

31

Jul

Australia TGA - GMP surveillance inspections and extended validity of GMP certificates

From 1 July 2024, we are introducing temporary new arrangements for GMP inspections of domestic and overseas manufacturers of medicines, Active Pharmaceutical Ingredients (APIs), biologicals and blood products. These inspections will be called ‘surveillance inspections.’..[TGA]

12

Sep

US FDA Guidance for Industry: ANDA Submissions – Amendments to ANDAs under GDUFA

FDA revised the final guidance for industry entitled, “ANDA Submissions – Amendments to Abbreviated...

11

Sep

Ministero Imprese: firmato il decreto per l’attivazione del Fondo IPCEI “Salute 1”

l ministro delle Imprese e del Made in Italy, Adolfo Urso, con apposito decreto, ha disposto l’attivazione...

11

Sep

US FDA Guidance Calls for Three-Step Mitigation Strategy for Nitrosamines

The FDA urges API and drug manufacturers to adopt a three-step mitigation strategy to prevent high levels...

11

Sep

Persone Qualificate delle officine farmaceutiche farmaci VETERINARI - Nuova disciplina Ministero Salute da Settembre 2024

Con riferimento al Regolamento (UE) 2019/6 e D.Lgs. 218/2023, il Ministero Salute ha ritenuto opportuno...

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