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HSA Extends Partnerships to Speed Access to Health Innovations Across Key Markets in Africa, Malaysia and Saudi Arabia

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17 September 2026

The Health Sciences Authority (HSA) is expanding regulatory reliance and cooperation across Africa, Malaysia and Saudi Arabia to reduce duplicated reviews, support faster access to safe and quality-assured health products, and strengthen Singapore’s role as a trusted regulatory gateway for biomedical innovation.

2 HSA announced these new and expanded collaborations between 14 and 16 September 2026 alongside the 30^th International Medical Device Regulators Forum (IMDRF) and the Drug Information Association Singapore Annual Meeting 2026. They comprise new agreements with the African Medicines Agency and the Saudi Food and Drug Authority, Malaysia National Pharmaceutical Regulatory Agency’s pilot use of HSA’s medicine assessments, and deeper work with the United Kingdom’s Medicines and Healthcare products Regulatory Agency. Together, these initiatives aim to reduce duplicated regulatory work, improve the efficiency of health product evaluations across jurisdictions, and widen the opportunities for regulators in African countries, Malaysia and Saudi Arabia to reference HSA’s regulatory work. This will in turn support more timely access to safe and innovative products, and strengthen Singapore’s biomedical ecosystem and international regulatory leadership.

Furthering Regulatory Reliance on HSA approvals to Support Patient Access to Health Products

3 Memorandum of Understanding (MOU) with Saudi Food and Drug Authority (SFDA) - HSA signed an MOU with SFDA on 14 September 2026, Monday. The MOU aims to foster cooperation and facilitate the exchange of expertise, information and best practices on pre-market and post-market matters, technical sharing, and explore facilitative regulatory pathways for both conventional and novel products, including those involving biotechnology and artificial intelligence.

4 Memorandum of Understanding (MOU) with African Medicines Agency (AMA) - HSA signed an MOU with AMA on 16 September 2026, Wednesday. The MOU establishes a framework for cooperation covering the exchange of regulatory information, collaboration on regulatory science and practices, capacity building, technical review and exploring the appropriate use of HSA’s approvals and assessments as references.

5 Regulatory Reliance in ASEAN: Malaysia - Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) began a pilot on 1 September 2026 to reference HSA’s assessments in its review of medicines. The pilot will test how regulatory reliance can reduce duplicated assessment work and support more timely access to medicines, while maintaining each authority’s standards for safety, quality and efficacy. Successful implementation could establish HSA as a reference agency for NPRA.

Deepening Collaboration with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Medicines and Artificial Intelligence

6 HSA also welcomed officials from the UK’s MHRA to Singapore. The agencies reaffirmed their commitment to the Regulatory Innovation Corridor, launched in December 2025, which gives developers of first-in-class medicines and frontier technologies early, iterative access to both regulators. This helps companies align earlier on evidence expectations, clinical trial design and regulatory pathways. On 15 September 2026, a Regulatory Innovation Forum brought together close to 100 participants (in-person and virtual) to examine uses of artificial intelligence in drug development and the related regulatory considerations.

Building Strong Foundation and Sustainable Frameworks for Science-Based Regulation Through 30th International Medical Device Regulators Forum (IMDRF)

7 During its 2026 chairmanship of the IMDRF, HSA advanced four practical deliverables: (i) a Reliance Playbook to help regulators build sustainable reliance frameworks; (ii) an Artificial Intelligence and Machine Learning Technical Framework to support harmonised oversight of AI-enabled medical devices; (iii) a new Cybersecurity Working Group to develop guidance on cybersecurity-by-design and testing; and (iv) further stakeholder training on Unique Device Identification, conformity assessment and reliance. Together, these initiatives strengthen regulatory consistency, help industry navigate multiple markets more efficiently and support safer medical devices worldwide.

8 At the IMDRF Stakeholder Forum, HSA also unveiled an LLM-enabled adverse event coding tool developed with GovTech Singapore. Using guard-railed large language model technology, the tool maps medical device adverse event information to established IMDRF coding frameworks, helping regulators compare data consistently across jurisdictions and identify safety signals more effectively. It is expected to save about 300 officer-hours each year in coding review and validation, freeing specialists to focus on higher-value safety analysis. The tool also provides a foundation for wider use of AI-assisted regulatory intelligence in health product oversight.

9 HSA Chief Executive Officer Adjunct Professor (Dr) Raymond Chua said: “A medicine or medical device should not have to wait because trusted regulators are repeating the same high-quality work. By enabling partners to draw on HSA’s assessments, we can reduce duplication, support more timely access to safe and effective health products, and help innovators reach patients across more markets. This week’s agreements turn regulatory trust into practical action — from Malaysia’s pilot use of HSA’s medicine assessments, to new cooperation with Saudi Arabia and Africa, and joint work with the United Kingdom on new frontier technologies. Our focus is clear: maintain rigorous standards while making the overall regulatory pathway more connected, efficient and responsive.”

10 At the close of the meeting, Singapore marked the transition of the IMDRF chairmanship to the Brazilian Health Regulatory Agency (ANVISA), which will assume the role from 2027. Adjunct Professor (Dr) Chua said: “Brazil brings deep regulatory experience, a strong commitment to public health and perspectives that will enrich IMDRF’s work. Singapore will remain an active partner as the Forum carries forward practical work on reliance, artificial intelligence, cybersecurity and regulatory convergence.”

11 About 400 regulatory and industry representatives from around the world attended the 30^th IMDRF meeting in Singapore, that provides a global platform to advance regulatory reliance, artificial intelligence, cybersecurity and convergence in medical device regulation.

(Refer to Annex A for Summary of Events and Annex B for photos.)

HEALTH SCIENCES AUTHORITY
SINGAPORE
17 SEPTEMBER 2026

ANNEX A

Summary of Events

Date	Key Highlights
14 – 18 September 2026	30^th International Medical Device Regulators Forum
14 September 2026	Signing of MOU between HSA and Saudi Food and Drug Administration
15 September 2026	Opening of 30^th International Medical Device Regulators Forum Regulatory Innovation Corridor Forum
16 September 2026	Drug Information Association Singapore Annual Meeting 2026 Signing of MOU between HSA and African Medicines Agency

ANNEX B

Memorandum of Understanding (MOU) with Saudi Food and Drug Authority (SFDA)

His Excellency Dr Hisham S. Aljadhey, Chief Executive Officer, SFDA (third from left), and Adjunct Professor (Dr) Raymond Chua, Chief Executive Officer, HSA (fourth from left), with delegates from SFDA and HSA.