The Saudi FDA drug evaluation timeline in comparison with international counterparts: a retrospective observational...

Regulatory agencies ensure the safety, efficacy, and quality of pharmaceuticals, influencing patient access to novel therapies. The Saudi Food and Drug Authority (SFDA) oversees drug evaluation in Saudi Arabia. This study evaluates SFDA's drug review times compared to other international agencies and assesses characteristics and approval timelines of novel drugs approved by the SFDA and the U.S. Food and Drug Administration (FDA) in 2019.

A retrospective observational study analyzed drug evaluation times from the SFDA and six international agencies: FDA, European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA), Health Canada, Pharmaceuticals and Medical Devices Agency (PMDA), and Swissmedic. The primary outcome was drug approval timeline, defined as days from submission to registration. Data on 48 novel drugs approved by the FDA in 2019 were collected and tracked for SFDA approval status through 2024. Descriptive statistics compared drug characteristics and evaluation times. A regulatory comparison used publicly available documents and reported timelines.

SFDA and EMA showed shorter median approval times (∼6.5 months), while Swissmedic (14.5 months) and PMDA (10.6 months) had longer timelines. Among 48 FDA-approved novel drugs in 2019, 21 (43.75%) were approved by the SFDA by mid-2024; 23 (47.92%) were not submitted for SFDA review, impacting coverage. Small molecules dominated approvals for both FDA (58.33%) and SFDA (64%). Advanced therapies such as gene therapies and synthetic peptide analogs were absent from SFDA approvals, mainly due to non-submission. Median approval times were comparable (SFDA: 248 days; FDA: 243 days), with greater variability observed in SFDA timelines.

SFDA's review timelines align with major regulatory agencies, supporting timely drug access. Further investigation into submission patterns and regulatory challenges may improve approval rates, especially for advanced therapies.