A Survey of Industry Perceptions of Facilitated Regulatory Pathways in Drug Development in Australia.

ABSTRACT:

Background

In Australia, facilitated regulatory pathways (FRPs) became available with the introduction of priority review (PR) in 2017 and provisional approval (PA) in 2018, which aim to facilitate expedited review and approval for novel medicines. The pathways were developed in consultation with a wide range of stakeholders and have since been utilised by pharmaceutical companies for various therapeutic products. However, the perceptions of the firsthand users of these pathways have not been evaluated in Australia.

Objectives

We have conducted a survey of Australian regulatory professionals aiming to solicit the perceived benefits, barriers to utilisation, shortcomings and proposed modifications to utilising these pathways. We have also solicited the users' perspective on k

SUBMITTER: Yoffe A 

PROVIDER: S-EPMC10460712 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature