The AUSFTA and 'Fast Track' Regulatory Approval of Medicines: Problems and Opportunities for Australian Academic Innovations in Nanotherapeutics

Abstract:     
This paper examines the proposition that the United States Food and Drug Administration (FDA) and Australia’s Therapeutic Goods Administration (TGA) will soon be coming under increasing pressure to prioritise so-called ‘fast-track’ approval pathways for innovative nanotherapeutics. It considers the relative risk this may result in compromised standards of safety and efficacy for such products. It also, however, investigates the opportunities this presents for developing new regulatory approval pathways for Australian academic innovations in nanotherapeutics.

‘Fast-tracking’ may be defined, for the purposes of this paper, as any regulatory pathway or process that a developer/manufacturer may utilise to secure more rapid quality, safety and efficacy regulatory approval prior to marketing of a therapeutic product. Although cost-effectiveness analysis in many jurisdictions (such as Australia) is another recognised regulatory hurdle prior to marketing approval, its role is not generally considered as part of ‘fast-track’ procedures. ‘Fast-tracking,’ however, may also be described, from a patient’s point of view, as any regulatory pathway or process that allows speedier access to new and presumptively ‘innovative’ health technologies.

Number of Pages in PDF File: 17

Keywords: Nanotechnology, nanomedicine, safety regulation, FDA, pharmaceutical regulation, fast-track

JEL Classification: O31, O34, M37, M14, L65, K31, H41, I18, D46

Accepted Paper Series