Nicole Tan

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The bio pharmacy: market authorisations for protein-based medicines

As their name suggests, biological medicines contain active substances such as proteins, peptides and polysaccharides made by living cells or organisms. While the market still features biological medicines formulated from...
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Formulated ingredients and premixes: Keeping the IP of a PI

Formulated ingredients or premixes are commonly used in many medicinal products – such as inks, coatings and colourants, fragrances and flavours, dosage form bases, and triturations or extracts of active...
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Your guide to claiming temporary exemption from TGO91/92 compliance

As described in the article, Addendum to TGA Deadlines: Medicine Labelling Compliance and COVID-19, 31 August 2020 marked the end of the medicines packaging reform transition. The intent of the...
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Look out…the new CMI templates are finally here

TGA’s updated CMI templates and guidance is finally live on their website! No new or additional content is required in the new templates. The intent was to revise the format...

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