Singapore expands regulatory reliance pacts to Africa, Malaysia and Saudi Arabia

The city-state aims to cut duplicated reviews and speed up access to health products.

Singapore's Health Sciences Authority (HSA) has expanded regulatory reliance agreements across Africa, Malaysia and Saudi Arabia, aiming to cut duplicated reviews and speed up access to health products.

HSA signed a Memorandum of Understanding (MOU) with the Saudi Food and Drug Authority, covering pre-market and post-market cooperation, technical information sharing, and regulatory pathways for conventional and novel products, including biotechnology and artificial intelligence.

The authority also signed a separate MOU with the African Medicines Agency, establishing a framework for exchanging regulatory information, collaborating on regulatory science, capacity building, and exploring the use of HSA's approvals as references.

Meanwhile, Malaysia's National Pharmaceutical Regulatory Agency (NPRA) began a pilot on 1 September to reference HSA's assessments in its medicine reviews.

If successful, the arrangement could position HSA as a reference agency for NPRA.

HSA’s CEO Adjunct Professor Raymond Chua said the agreements convert regulatory trust into practical action, citing Malaysia's pilot, the new Saudi and African partnerships, and joint work with the UK on frontier technologies.

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