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Category Archives: Regulatory Services

Relating to Regulatory Services of Life Sciences Industry

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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What is Happening with the Provisional Approval Pathway?

We’ve come a long way When the independent review of medicines and medical devices regulation was announced in October 2014, the pharmaceutical sector immediately saw the opportunity for an expediated approval pathway for certain prescription medicines. A provisional approval pathway would allow … 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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Warning: This medical device literature review may contain traces of LBS

With the release of new clinical evidence guidelines for medical devices, sponsors and manufacturers will be expecting some further guidance on the structure, content and quality of their clinical evaluation reports (CERs). Once final, this guidance will be used in … Continue reading

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Ready? Get Set…Go! Planning the most appropriate strategy for your product to enter the Australian market

As we weave our way through life, we plan…plan our career, plan our finances, plan a holiday and most of us would have at least once in our lifetime planned a party. The key to a successful plan is finding … Continue reading

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Are you eCTD ready?

eCTD in Australia Following the successful eCTD pilot programme in 2014/2015, the TGA has published the final Australian eCTD specification (version 3.0) which is now mandatory for all dossiers submitted in eCTD format after 1 January 2016. This is an … Continue reading

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