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Tag Archives: Biosimilars

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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Dr Greg Pearce – Time to support biosimilars

Dr Greg Pearce, from our Regulatory Services team, has written a follow-up article for Pharma in Focus on biosimilars. Dr Pearce’s first article focussed on the challenges biosimilars pose for the Australian medicines industry. This second article looks at the … Continue reading

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Dr Greg Pearce – Australia must agree on biosimilar approach

Our new Director, Regulatory Services, Dr Greg Pearce, has written an article for Pharma in Focus on the challenges biosimilars pose for the Australian medicines industry. The article looks at the uncertainties that are yet to be resolved, as well … Continue reading

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2014 ARCS scientific congress: Naming biosimilar medicines – are we any closer?

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