TGA

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The bio pharmacy: market authorisations for protein-based medicines

As their name suggests, biological medicines contain active substances such as proteins, peptides and polysaccharides made by living cells or organisms. While the market still features biological medicines formulated from...
Checklist

Australia’s TGA releases updated Essential Principles Checklist

In Australia, for any given device, irrespective of risk classification, manufacturers must demonstrate compliance with the Therapeutic Goods Administration (TGA) essential principles. The essential principles define the requirements for the...
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It’s all about Access!

In Australia, there are a number of options where patients can gain access to products that have not been approved for use. Some of these options are described below. Authorised...
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Prescription Medicine Pathways

The standard regulatory evaluation pathway in Australia for new prescription medicines involves a thorough TGA review of data demonstrating safety, efficacy +/- quality. In addition to the standard regulatory pathway...
Electronics

Transition Plan and Regulatory Changes for Software as Medical Devices

In our November 2020 blog post, we communicated the changes regarding the implementation dates and the criteria for Software as a Medical Device regulations as amended in the Therapeutic Goods...
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Transition plan from Custom device to Patient-matched

In our Blog of June 2020, we communicated on the delays relating to the implementation dates of the December 2019 amendment of the Therapeutic Goods (Medical Devices) Regulations 2002. The...
Vaccine and Vial

Provisionally yours

The development of new medicines and expanding the use of existing medicines is a resource-intensive process, where it can take a number of years to complete the clinical trials necessary...
Pile of Documents

DOC’s will need to be submitted for new Class I IVD ARTG registrations

Similarly, to TGA’s recent notification on 1 October 2020, the TGA has issued a notice of upcoming changes for Class IVD registrations via an email to stakeholders on 17 November...
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Formulated ingredients and premixes: Keeping the IP of a PI

Formulated ingredients or premixes are commonly used in many medicinal products – such as inks, coatings and colourants, fragrances and flavours, dosage form bases, and triturations or extracts of active...
Electronic Medical Record

TGA guidance for SaMD Regulatory “Carve Out”

Following a public consultation on the Regulation of software, including Software as a Medical Device (SaMD) in early 2019, the TGA introduced several regulatory changes, including: new classification rules for...

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