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Singapore's regulatory body Health Sciences Authority (HSA) is expanding 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.
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.
Memorandum of Understanding (MoU) with Saudi Food and Drug Authority (SFDA) - 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.
Memorandum of Understanding (MoU) with African Medicines Agency (AMA) - 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.
Regulatory Reliance in ASEAN- 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.
