TGA

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TGA deploys Post Market Review Compliance Dashboard

Under the Therapeutic Goods Act 1989, it is mandatory for sponsors and manufacturers to report adverse events that have, or could have, led to death, serious illness or injury to...
Time Lapse

TGA Issues guidance for sponsors with lapsing Conformity Assessment Certificates

On 13 October 2020, the TGA specified that it will take a broader view in the case that companies suffer a lapse on renewing their Conformity Assessment Documents in response...
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TGA will require DOC’s to be submitted for Class I ARTG registrations

Australia’s, Therapeutic Goods Administration (TGA) issued a notice on 1 October 2020, in addition to an email to stakeholders prior, specifying new policies for the inclusion of non-sterile, non-measuring Class...
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Your guide to claiming temporary exemption from TGO91/92 compliance

As described in the article, Addendum to TGA Deadlines: Medicine Labelling Compliance and COVID-19, 31 August 2020 marked the end of the medicines packaging reform transition. The intent of the...
Pathways

Australian Prescription Medicine Pathways – Project Orbis

Project Orbis is an initiative of the US FDA Oncology Centre of Excellence (OCE). The intent of Project Orbis is to provide a framework for concurrent submission and review of...
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TGA Advertisement Framework Revisions Hard at Work During Pandemic Times

Marking the second year after the issuance of the revised TGA Advertising framework, the TGA has evidenced a strong hard-line position on enforcements against the illegal import, supply, and advertising...
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What you need to know about disinfectants in Australia

In May 2020, we looked at hand sanitisers and TGA’s exemption on certain formations in response to the COVID-19 emergency. As we are seeing an increasing number of corporations receiving...
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That’s ODD: can your medicine benefit from incentives for treating rare disorders?

The time, resources, and costs of developing and marketing medicines are extensive – putting treatments for rare disorders at a distinct disadvantage since the potential return on investment is limited...
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TGA published review of safety and performance issues in Medical Device software

Software as a Medical Device (SaMD) In recent years software usage has become ubiquitous and software resources, particularly mobile apps accessible through smartphones, have increased in complexity and usage. The...
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FAQs Regarding the Australian R&D Tax Incentive and Regulatory Services

The Australian R&D Tax Incentive and Regulatory Services As we navigate through the global pandemic of COVID-19, Australian R&D Tax Incentives continue to be of significant relevance for companies exploring...

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