THE Therapeutic Goods Administration has posted a presentation on a local perspective around early access to medicines by its Prescription Medicines Authorisation Branch assistant secretary Adrian Bootes to the International Society of Pharmacovigilance Training Course mid-Mar this year.
The presentation gave an overview of Australian expedited pathways, some considerations for implementation and other options for early access in Australia.
The drug eligibility criteria were presented with a flow chart on the pre-submission, submission and priority review processes, as well as the provisional approval pathway.
International harmonisation principles were also developed.
Visit tga.gov.au for access.
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