Saudi NIH issues draft grant regulations

On 3 January, the Saudi National Institute for Health Research (‘SNIH’) posted for public comment a draft regulation concerning the issuing of grants by the SNIH (‘Draft Regulation’). Public comments remain open until 18 January 2024 here.

The overall aim of the Draft Regulation is to organise the funding for translational research and clinical trials in the areas and programs supported by SNIH. Specifically, the scope of the Draft Regulation includes:

1. Organising support for translational research and clinical trials and translating them into quality and efficient products and solutions to develop the health sector, including investing in them in coordination with relevant authorities;
2. Enabling individuals and entities to obtain research grants in the field of translational research and clinical trials with full transparency; and
3. Organising and managing the technical, financial, and administrative aspects of various grant programs.

Articles of the Draft Regulation cover

1. Applying for and accepting grants;
2. Budgeting and financing;
3. Contracting and implementation;
4. Grants management;
5. Follow-up and reports; and
6. General provisions.

SNIH Background

Compared to the almost 36 million population, there are not enough clinical trials conducted in KSA, particularly as they relate to the specific genome of the Saudi population. In August 2023, the Saudi Cabinet announced the approval of the Saudi National Institute for Health Research. 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 Arabia’s national development and diversification plan, Vision 2030, and national health priorities concerning the research, development, and innovation (RDI) sector.

When looking at the wider regulatory landscape, currently, the Saudi Food and Drug Authority (“SFDA”), through its clinical trials administration and the 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.

As Vision 2030 and national health priorities concerning RDI remain strong, we expect further announcements concerning the development of the SNIH and its role to unfold during 2024.

How can we help?

Al Tamimi & Company’s Healthcare & Life Sciences practice in Saudi Arabia spans all three of our KSA offices (Riyadh, Jeddah, & Al Khobar) and is well placed to advice on regulatory matter impacting the healthcare life sciences industries, such as the subject matter of this client alert.