12 February 2024

josleen deeb

The Saudi National Institute for Health Research (SNIH) has released a draft regulation on January 3, seeking public input until January 18, 2024. The SNIH's role, particularly in the context of Saudi Arabia's regulatory landscape, is expected to unfold further in 2024, contributing to the growth of clinical trials in the Kingdom.

Riyadh: This Draft Regulation aims to streamline funding for translational research and clinical trials in collaboration with relevant authorities, ensuring transparency in obtaining research grants. Covering various aspects like application, budgeting, contracting, and management, the regulation aligns with Vision 2030 and the national health priorities, emphasizing the importance of research, development, and innovation.

This proposed regulation aims to streamline the allocation of funds for translational research and clinical trials within the SNIH-supported areas and programs. The scope of the draft regulation includes:

  1. Organizing support for translational research and clinical trials to develop the health sector efficiently and in coordination with relevant authorities.
  2. Facilitating transparent access to research grants in translational research and clinical trials for individuals and entities.
  3. Managing the technical, financial, and administrative aspects of various grant programs.
The articles of the draft regulation cover applying for and accepting grants, budgeting and financing, contracting and implementation, grants management, follow-up and reports, and general provisions.

  • Background on SNIH:
Despite a population of nearly 36 million, there is a shortage of clinical trials in the Kingdom of Saudi Arabia (KSA), especially related to the specific genome of the Saudi population. In August 2023, the Saudi Cabinet approved the establishment of the Saudi National Institute for Health Research, focusing on overseeing and promoting translational research and clinical trials. This initiative aligns with Saudi Arabia’s Vision 2030 and national health priorities, emphasizing research, development, and innovation (RDI).

Currently, the Saudi Food and Drug Authority (SFDA) oversees clinical trials in KSA through its clinical trials administration and the Saudi Clinical Trials Registry (SCTR). The SNIH is expected to play a crucial role in shaping the regulatory landscape for clinical trials in Saudi Arabia, and further developments and announcements regarding its role are anticipated in 2024.


In the quest for advancing healthcare through groundbreaking research, the SNIH has a clear wish to transform the regulations, aiming to invigorate translational research and clinical trials. As public comments unfold until January 18, 2024, the SNIH emerges as a catalyst for change, aligning with Saudi Arabia's ambitious Vision 2030. The shortage of clinical trials, coupled with the SNIH's focus on the Saudi genome, underscores the institute's pivotal role in reshaping the research landscape. Anticipate a revolutionary era in healthcare research as the SNIH unfolds its initiatives, forging a path towards a healthier and more innovative future. 


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