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
Posted in Life Sciences Industry, Regulatory Services, TGA
Tagged Biosimilars, eCTD, Prescription Medicines, Regulatory Services
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7 ways to give your Prescription Medicine Registration submission the best chance of success
Posted in Life Sciences Industry, Regulatory Services
Tagged 2014 ARCS Scientific Congress, Prescription Medicines
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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
Posted in Regulatory Services, TGA
Tagged Evaluation Process, Prescription Medicines
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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
Posted in Regulatory Services, TGA
Tagged Evaluation Process, Prescription Medicines, Top 5
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