Understanding AU and US Regulatory Frameworks for Drug Development.
Understanding AU and US Regulatory Frameworks for Drug Development
Require a detailed, referenced paper defining:
1/. The pharmaceutical registration system via the Therapeutic Goods Administration (TGA)
2/. An in depth look at the Australian medicine co-payment system via the Pharmaceutical Benefits Advisory Scheme (PBAC) as it applied to listing new medicines for co-payment. Include financial transparency and modelling.
3/. The pharmaceutical registration system via the Food and Drug Administration (FDA) in the USA
4/. An in depth look at any pharmaceutical subsidised payment scheme via the US Federal Government
5/. A comparison of the AU and US system noting similarities and differences.
Key areas include:
2/. Time lines
3/. New pharmaceutical registrations in both systems charted over the past decade. Same with cost and time charting, to determine if their are less pharmaceuticals entering the market, costing suppliers money in both dollars and time.
4/. Failure rates of registrations over the past decades
5/. Proposed changes to the registration schemes over the past decade (if discoverable) and acceptance or refitting remarks.