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...
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...
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...
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...
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...
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...
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...
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...
