Singapore and China broaden drug oversight deal to cover gene therapies

It alters regulatory pathway structure for emerging medical technologies.

The Health Sciences Authority (HSA) and China’s National Medical Products Administration expanded their regulatory cooperation to include cell, tissue, and gene products. 

In a press release, the HSA said the memorandum of understanding (MOU) signed on 11 May 2026 in Beijing also includes existing collaboration on drugs, biologics, medical devices, traditional Chinese medicines, and cosmetics.

It also extends joint work into emerging therapeutic areas and sets out collaboration on facilitative regulatory pathways, pilot schemes, capacity building, and staff exchanges.

Both regulators will continue cooperation on regulatory information exchange, standards and best practices, and joint efforts to address counterfeit, falsified, and substandard health products, including manufacturing inspections and testing.

The renewal builds on a 2021 MOU between the two agencies and extends more than 20 years of regulatory engagement between Singapore and China, which began in 2003 with the first agreement between HSA and China’s then State Food and Drug Administration.

HSA said the expanded scope supports faster access to innovative health products whilst maintaining robust standards of safety, quality, and efficacy.

It also said the cooperation strengthens regulatory responsiveness in emerging areas of medical innovation.

The expanded framework may support more efficient development, evaluation, and market access processes for new therapeutics and medical technologies, alongside regulatory capability development.

Adjunct Professor (Dr) Raymond Chua, CEO of HSA, said the agreement reflects continued partnership between both regulators and expands cooperation into new therapeutic areas, including gene and cell therapy products.

HSA stated that around 35 medicines and more than 1,000 medical devices manufactured in China have received approval in Singapore.