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Tag Archives: Regulatory Services

Commercial Eyes appoints Simon Higgins to head up new Commercialisation Services division

Commercial Eyes Pty. Ltd., one of Australia’s most successful health technology commercialisation companies, is pleased to announce the appointment of Simon Higgins to head up it’s new Commercialisation Services division. Simon joins Commercial Eyes with over 20 years’ experience in … Continue reading

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No CE mark? No problem.

Changes to legislation have increased flexibility for Sponsors looking to market medical devices in Australia. Historically the TGA has only recognised EC certificates from European notified bodies or a TGA conformity assessment to support the inclusion of a Medical Device … Continue reading

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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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Making the most of complementary medicines reforms

In March this year the TGA finally started rolling out the long awaited Complementary Medicine Reforms.    One of the most significant changes for sponsors of listed complementary medicines is the abolition of the “free text” box for indications.  All … Continue reading

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New ‘SmPC’ Format for the Australian Product Information

The TGA have published a new form for providing the product information (PI) which means more work for regulatory teams but an enhancement of the quality use of medicines for Australian patients.  The new form will be implemented over a … Continue reading

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Transition to eCTD is gaining momentum in Australia

At the 2017 ARCS Annual Conference, the TGA announced that applications considered under the priority review pathway will be required to be submitted in eCTD format. In making this important announcement, the TGA acknowledged the clear benefits of eCTD for … Continue reading

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Stressed? Well your products should be!

Treating your drug substance or drug product with an acid, a base, an oxidising substance, heat or exposing it to direct light might sound extreme, but that is exactly what the TGA want to see in your registration dossier. Assay … Continue reading

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Medicine labels: TGO 91 and TGO 92. What’s the impact?

Following years of consultation and review the TGA has issued two new labelling orders to replace the current Therapeutic Good Order No. 69 for specific medicine labelling requirements: Therapeutic Goods Order No. 91 – Standard for labels of prescription and … Continue reading

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Commercial Eyes Recruiting: Regulatory Services Manager

Commercial Eyes has a great opportunity for a Regulatory Services ManagerReporting to the Director, Regulatory Services, the Manager is responsible for the day to day operational management of the regulatory team and the assigned project portfolio within the Regulatory Services … Continue reading

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Commercial Eyes recruiting: Regulatory Consultant

Commercial Eyes has a unique opportunity for an experienced professional to join our Regulatory Services team In this role, you will be providing Regulatory Affairs and Quality consulting services to the clients of Commercial Eyes. This position may be based … Continue reading

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