Saudi Food and Drug Authority (SFDA) CEO Dr. Hisham Aljadhey held a roundtable meeting with executives and representatives of leading South Korean private-sector companies in Seoul on November 4, 2026, to explore cooperation in biotechnology and advanced therapies. The meeting took place on the sidelines of his participation in the International Coalition of Medicines Regulatory Authorities (ICMRA) Summit, in the presence of Saudi Arabia’s Commercial Attaché Saeed Almadani, according to the Saudi Press Agency (SPA). The discussions focused on exchanging scientific and regulatory expertise and leveraging the research and technical capabilities of both sides. The engagement reflects the Kingdom’s commitment to strengthening its position as a global hub for biotechnology, in line with the objectives of Saudi Vision 2030.
The roundtable brought together Korean companies active in the biotechnology and advanced therapies sector, including those developing cutting-edge treatments such as CAR T-cell therapies. Dr. Aljadhey highlighted the SFDA’s efforts to advance its regulatory framework in line with scientific and technological developments, expedite the registration of treatments, and facilitate their availability to patients while ensuring compliance with quality, efficacy, and safety standards. The meeting also aimed to strengthen communication between the SFDA and Korean companies regarding regulatory requirements and pathways for registering advanced therapies. This collaboration is expected to accelerate the introduction of innovative treatments in the Kingdom and enhance patient access to life-saving therapies.
Context and Background
Why is the SFDA’s engagement with South Korean biotechnology firms significant for global health innovation? The meeting in Seoul is part of a broader strategy by Saudi Arabia to position itself as a leader in biotechnology and advanced therapies. The SFDA has been actively modernizing its regulatory framework to keep pace with rapid scientific advancements. In recent years, the authority has introduced several initiatives, including the “NADR” pathway, designed to accelerate the introduction of medicines for rare diseases, and new regulatory pathways for advanced therapies. These efforts are aligned with the National Biotechnology Strategy, which aims to make Saudi Arabia a leading global hub in this field. The strategy supports the objectives of Saudi Vision 2030, which seeks to diversify the economy and enhance the quality of life for citizens and residents.
The Riyadh Biocentral Foundation plays a crucial role in enabling research and innovation, fostering integration between research entities and the public and private sectors, and building partnerships with specialized international centers and companies. By collaborating with Korean companies, the SFDA aims to leverage their expertise in advanced therapies, particularly in areas such as CAR T-cell therapy, which has shown promise in treating certain types of cancer. The exchange of scientific and regulatory expertise is expected to benefit both sides, facilitating the development and registration of innovative treatments. This cooperation also underscores the Kingdom’s commitment to international collaboration in health care and life sciences.
Key Details of the Meeting
What specific opportunities were discussed during the roundtable? Dr. Aljadhey showcased the SFDA’s notable initiatives, including the “NADR” pathway and newly introduced regulatory pathways for advanced therapies. These pathways are designed to support the introduction of innovative treatments in the Kingdom by streamlining regulatory processes while maintaining rigorous standards for quality, efficacy, and safety. The discussions explored opportunities to exchange scientific and regulatory expertise and leverage the research and technical capabilities of both sides. Korean companies expressed interest in understanding the SFDA’s regulatory requirements and pathways for registering advanced therapies, which could pave the way for their products to enter the Saudi market.
Separately, Dr. Aljadhey toured a Korean research institution specializing in CAR T-cell therapy. He reviewed its key research projects and the technologies used in developing these advanced therapies, while exploring potential avenues for exchanging expertise in scientific and regulatory areas of mutual interest. CAR T-cell therapy is a type of immunotherapy that genetically modifies a patient’s T cells to target cancer cells. This visit highlights the SFDA’s proactive approach to learning from global leaders in biotechnology and applying best practices to the Saudi regulatory environment. The knowledge gained could inform the SFDA’s oversight of similar therapies and support the development of local capabilities.
International and Regional Impact
How does this cooperation affect the broader Middle East and North Africa region? Saudi Arabia’s efforts to advance biotechnology and advanced therapies have significant implications for the region. As the largest economy in the Middle East, the Kingdom’s regulatory advancements can serve as a model for other countries seeking to enhance their own health care systems. By partnering with international leaders like South Korea, Saudi Arabia is not only improving its own health care landscape but also contributing to global health security. The exchange of expertise can lead to faster development and distribution of innovative treatments, benefiting patients worldwide. Moreover, this collaboration strengthens diplomatic and economic ties between Saudi Arabia and South Korea, two nations with complementary strengths in technology and health care.
Regionally, the SFDA’s initiatives align with the goals of the Gulf Cooperation Council (GCC) to enhance health care cooperation among member states. The Kingdom’s leadership in regulatory innovation can drive regional harmonization of standards, facilitating the faster approval of medicines across the GCC. This, in turn, can improve patient access to cutting-edge therapies and bolster the region’s resilience against health crises. The partnership with Korean companies also opens doors for joint ventures and knowledge transfer, which can spur local manufacturing and research and development, creating high-skilled jobs and fostering economic diversification.
Economic and Strategic Significance
What economic benefits can Saudi Arabia expect from this collaboration? The biotechnology and advanced therapies sector is a key pillar of Saudi Arabia’s economic diversification strategy under Vision 2030. By attracting foreign investment and fostering partnerships with global leaders, the Kingdom aims to build a robust local biotech industry. The transfer of knowledge and technology from Korean companies can enhance the capabilities of Saudi researchers and institutions, leading to the development of homegrown innovations. This, in turn, can reduce reliance on imported treatments and create export opportunities for Saudi-made biopharmaceuticals. The SFDA’s streamlined regulatory pathways make the Kingdom an attractive destination for companies seeking to introduce advanced therapies, potentially generating significant revenue and reinforcing Saudi Arabia’s position as a regional hub for life sciences.
Strategically, the cooperation with South Korea is part of Saudi Arabia’s broader efforts to strengthen ties with Asian economies. South Korea is a global leader in biotechnology and has a strong track record in research and development. By partnering with Korean firms, the Kingdom can accelerate its own technological advancement and gain access to cutting-edge therapies. This collaboration also supports the objectives of the National Biotechnology Strategy, which aims to localize the biotech industry and create a knowledge-based economy. Furthermore, it enhances Saudi Arabia’s soft power by demonstrating its commitment to global health and innovation, aligning with its role as a responsible international stakeholder.
Vision 2030 Alignment
How does this meeting contribute to Saudi Vision 2030? The SFDA’s engagement with Korean companies directly supports Vision 2030’s goals of diversifying the economy, improving health care, and fostering innovation. The National Biotechnology Strategy is a key initiative under Vision 2030, designed to position Saudi Arabia as a global hub for biotechnology. By collaborating with international partners, the Kingdom can accelerate the development of its biotech sector, create high-value jobs, and enhance its competitiveness. The SFDA’s efforts to modernize regulatory pathways, such as the “NADR” pathway and advanced therapies pathways, demonstrate the Kingdom’s commitment to ensuring timely access to innovative treatments while upholding safety and efficacy standards. This aligns with Vision 2030’s aim to provide world-class health care to citizens and residents.
Looking ahead, the partnership with South Korea is expected to yield tangible outcomes, including joint research projects, regulatory exchanges, and potential investments in Saudi Arabia’s biotech infrastructure. The Riyadh Biocentral Foundation will play a pivotal role in facilitating these collaborations, serving as a bridge between research entities, the public sector, and private companies. As Saudi Arabia continues to advance its regulatory framework and build international partnerships, it reinforces its position as a leader in global health innovation. This meeting marks another step toward realizing the Kingdom’s ambitious vision for a diversified, knowledge-driven economy and a healthier future for all.
20 Questions
Q1. What was the purpose of the SFDA CEO’s meeting with Korean companies?
A1. The meeting aimed to discuss opportunities for cooperation in biotechnology and advanced therapies, exchange scientific and regulatory expertise, and strengthen communication regarding regulatory requirements for registering advanced therapies in Saudi Arabia.
Q2. Where did the roundtable meeting take place?
A2. The roundtable meeting took place in Seoul, South Korea, on the sidelines of the International Coalition of Medicines Regulatory Authorities (ICMRA) Summit.
Q3. Who represented Saudi Arabia at the meeting?
A3. The meeting was led by Dr. Hisham Aljadhey, CEO of the Saudi Food and Drug Authority (SFDA), in the presence of Saudi Arabia’s Commercial Attaché Saeed Almadani.
Q4. What is the “NADR” pathway?
A4. The “NADR” pathway is an SFDA initiative designed to accelerate the introduction of medicines for rare diseases, ensuring faster access to treatments for patients with unmet medical needs.
Q5. What are advanced therapies?
A5. Advanced therapies are innovative treatments such as gene therapy, cell therapy, and tissue engineering that aim to treat diseases at the genetic or cellular level, often for serious conditions.
Q6. How does the National Biotechnology Strategy align with Vision 2030?
A6. The National Biotechnology Strategy supports Vision 2030 by aiming to make Saudi Arabia a global hub for biotechnology, fostering economic diversification, innovation, and high-skilled job creation.
Q7. What is the role of the Riyadh Biocentral Foundation?
A7. The Riyadh Biocentral Foundation enables research and innovation, fosters integration between research entities and the public and private sectors, and builds partnerships with international centers and companies.
Q8. What type of research institution did Dr. Aljadhey visit?
A8. Dr. Aljadhey toured a Korean research institution specializing in CAR T-cell therapy, a type of immunotherapy used to treat certain cancers.
Q9. What is CAR T-cell therapy?
A9. CAR T-cell therapy is a treatment that genetically modifies a patient’s T cells to target and destroy cancer cells, representing a promising advance in immunotherapy.
Q10. How does this cooperation benefit Saudi patients?
A10. It can accelerate the availability of innovative treatments in Saudi Arabia, improve access to advanced therapies, and ensure they meet quality, efficacy, and safety standards.
Q11. What are the economic benefits for Saudi Arabia?
A11. The cooperation can attract foreign investment, foster local biotech industry growth, create high-skilled jobs, and support economic diversification under Vision 2030.
Q12. How does this collaboration impact the region?
A12. It can enhance regional health care cooperation, harmonize regulatory standards, and improve patient access to cutting-edge therapies across the Middle East and North Africa.
Q13. What is the ICMRA Summit?
A13. The ICMRA Summit is a global forum where medicines regulatory authorities convene to discuss strategic priorities, regulatory science, and international collaboration.
Q14. How does the SFDA ensure the safety of advanced therapies?
A14. The SFDA evaluates advanced therapies through rigorous regulatory pathways that assess quality, efficacy, and safety before approval, ensuring patient protection.
Q15. What opportunities exist for Korean companies in Saudi Arabia?
A15. Korean companies can access the Saudi market by registering their advanced therapies through SFDA pathways, collaborate on research, and potentially establish local manufacturing.
Q16. How does this meeting strengthen Saudi-Korean relations?
A16. It deepens bilateral ties by fostering collaboration in health care and biotechnology, promoting knowledge exchange, and creating economic opportunities for both nations.
Q17. What are the next steps following this meeting?
A17. Next steps include continued dialogue, potential joint research projects, regulatory exchanges, and exploring avenues for Korean companies to introduce advanced therapies in Saudi Arabia.
Q18. How does the SFDA support innovation in biotechnology?
A18. The SFDA supports innovation by modernizing regulatory frameworks, introducing expedited pathways like NADR, and engaging with international experts to stay abreast of scientific developments.
Q19. What is the significance of the Riyadh Biocentral Foundation for Vision 2030?
A19. It is a key enabler of the biotechnology ecosystem, driving research, innovation, and partnerships that align with Vision 2030’s goals of economic diversification and global leadership.
Q20. How does this collaboration reflect Saudi Arabia’s global role?
A20. It demonstrates Saudi Arabia’s commitment to international cooperation in health innovation, positioning the Kingdom as a responsible global leader in regulatory science and biotechnology.
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