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