Saudi Approves National Institute for Health Research (SNIH) to Advance the Clinical Trials and Research Environment

In August 2023, the Saudi Cabinet announced the approval of the Saudi National Institute for Health Research (“SNIH”). The institute will focus on supervising and promoting the value of translational research – turning basic research into practical results – and clinical trials. This announcement is in line with the objectives of Saudi’s national development and diversifications plan, Vision 2030, and national health priorities concerning  the research, development, and innovation (RDI) sector.

Currently, the Saudi Food and Drug Authority (“SFDA”), through its clinical trials administration and Saudi Clinical Trials Registry (“SCTR”) – a database of all clinical trials in KSA -, is responsible for approving and overseeing clinical trials in KSA. The SFDA evaluates protocols of clinical trials and amendments, and enforces Good Clinical Practice. Currently, sponsors and researchers must register their clinical trials using SCTR’s electronic portal. Historically, the SFDA focuses predominantly on phase 3 and phase 4 clinical studies.

Compared to the almost 36 million population, there are not enough clinical trials conducted in KSA particularly as relates to the specific genome of the Saudi population. As KSA reorganizes its various healthcare and life sciences regulatory and operational entities, we are staying abreast of the latest developments to see how the new SNIH and the SFDA will collaborate together – or transfer authority from SFDA to SNIH – in relation to the regulation and oversight of clinical trials in KSA.