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