OBJECTIVES: Pharmaceuticals’ often lengthy time-to-market is largely determined by the duration of regulatory agency review, where inefficiencies can often lead to backlogs that delay approval. To speed access to innovative medicines, governments have recently developed accelerated approval pathways (AAPs). This study aims to examine the performance of these AAPs in comparison with standard approval pathways (SAPs) in Australia, Canada, and Saudi Arabia.

METHODS: Regulatory agency websites were systematically reviewed for data and guidelines concerning market approvals. Median approval time (MAT) for new chemical entities (NCEs) was estimated by calculating the median difference between date of submission and the date of approval for 42 products approved in 2016–2017.

RESULTS: The MAT for NCEs was 307, 356, and 500 days in Australia, Canada, and Saudi Arabia, respectively. In Australia, 13 applications were accepted to the new priority review pathway since its mid-2017 inception. Among those, 2 have been approved to date, at a MAT of 145 days. In Canada, 4 NCEs were approved through the priority pathway, with a MAT of 246 days. The majority of priority products in these countries were oncology drugs (60%), with genetic and rare diseases accounting for the remainder. The Saudi FDA did not publish details of applications logged through its new abridged/verification approval pathway.

CONCLUSIONS: Drugs that met eligibility criteria, particularly oncology drugs, obtained earlier approval through AAPs. Compared to SAP, AAP-reviewed drugs were approved 40% and 30% faster in Australia and Canada, respectively. In both countries, MAT through the SAP also falls within 5% of regulatory agency targets. Saudi Arabia’s recently introduced AAP offers similar promise but there is reason for skepticism regarding its ability to address approval delays. MAT through SAP is notably longer in Saudi Arabia than the 290-day target as full and lengthy assessments of drugs — including product testing —are conducted by Saudi FDA.