Saudi Arabia Reports Surge in Clinical Trials for Biotech Therapies

Saudi Arabia recorded an 83% increase in clinical trial applications for advanced therapies and biotechnology products in 2025 compared with 2024, according to data released by the Saudi Food and Drug Authority. The authority also reported a 39% rise in early-stage clinical trials over the same period, reflecting broader expansion across the research pipeline.

The authority said approximately 2,700 patients accessed innovative and advanced treatments through participation in clinical trials during the year. These trials provided access to therapies that are still under evaluation, offering patients additional treatment options within regulated research settings.

A key contributor to the increase was the Reliance Pathway for Clinical Trials, an approval mechanism designed to streamline regulatory processes. The authority said the pathway reduced study approval timelines by 74% compared with the standard regulatory track, improving operational efficiency and supporting efforts to attract global clinical research to the Kingdom.

According to the authority, shorter approval timelines help accelerate patient access to medicines that meet quality and safety standards while strengthening Saudi Arabia’s position as a destination for international clinical trials. The framework is intended to balance faster approvals with regulatory oversight.