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Tag Archives: Prescription Medicines

Are you ready for the mandatory transition to eCTD for prescription medicines?

In October 2018 the TGA announced the long-awaited timelines for transition to eCTD. A staged implementation has been proposed for prescription medicines to reflect the current industry uptake of the eCTD format. The transition begins with new chemical entity, new … Continue reading

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7 ways to give your Prescription Medicine Registration submission the best chance of success

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TGA Reforms: The Verdict

The Therapeutic Goods Administration (TGA) will on 1 November officially commence operating according to the new Streamlined Submission Process for Prescription Medicines. We assess the likely long-term impact on market access in Australia. Continue reading

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The Top 5 – Tips on the TGA’s Streamlined Evaluation Process

This month’s Top 5 looks at how to help your regulatory affairs team deal with the TGA’s new Streamlined Evaluation Process for Prescription Medicines.  Continue reading

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