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Category Archives: TGA

Relating to the Australian Therapeutic Goods Administration

TGA Inspections are Coming – Is your Company Ready?

The TGA has recently concluded its pilot program in Pharmacovigilance inspections in Australia.  Numerous companies volunteered to take part in this inspection program, and from those volunteers the TGA selected ten companies.  The selection process by the TGA considered a) … Continue reading

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What is food for special medical purposes (FSMP)?

With a greater recognition of the importance of nutritional support in medical therapy and improved technology, the “food for special medical purposes” (FSMP) market is currently surging. However, many questions arise, what is food for special medical purposes? Where can … 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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Proposed updates to GVP Module VI and what this might mean for our clients

Good pharmacovigilance practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU). GVP apply to marketing-authorisation holders, the European Medicines Agency and medicines regulatory authorities in EU Member States. The … 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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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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Using an overseas reference product in your bioequivalence studies

It is the TGA’s preference that bioequivalence (BE) studies to support generic medicines are performed using the Australian (AU) innovator product as the reference; however, within certain TGA conditions, it is possible to use an overseas reference/innovator product in your … Continue reading

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Supporting prescribers to gain access to unapproved medicines

Pharmaceutical companies are able to support prescribers in their endeavours to deliver positive outcomes to patients who require access to medicines or devices that have not yet been approved in Australia. Although Sponsors are not directly involved in the TGA … Continue reading

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