Building Shanghai-HK Fast Track for Drugs, Medical Devices: Political Advisor

A political advisor has called for a pilot program at Shanghai's Eastern Hub International Business Cooperation Zone to speed up access to drugs and medical devices already approved in Hong Kong but not yet available on the Chinese mainland.

Carl Wu, chief executive officer of United Family Healthcare and a Shanghai political advisor, made the proposal during this year's Two Sessions.

"As a medical professional who has long worked in both Shanghai and Hong Kong, I often face a real problem," Wu told a panel discussion at the session.

Many innovative drugs and medical devices that are routinely used in Hong Kong and overseas have not yet been launched on the mainland, he said.

Wu noted that the delay pushes some patients to seek treatment overseas or in other regions. It also limits some early clinical use that could support research and development in Shanghai.

He said the Eastern Hub zone offers suitable conditions to test new medical access policies.

Approved by the State Council, China's Cabinet, in February 2024, the Eastern Hub is between Pudong International Airport and the planned Shanghai East Railway Station. It covers 0.88 square kilometers, equivalent to about 120 standard football pitches.

The eastern half, about 0.44 square kilometers, is now operating as a pilot area. The zone follows a special regulatory model that allows easier cross-border movement while maintaining oversight.

Eligible overseas business visitors may enter without a Chinese visa through an invitation-based system.

Wu said the zone's design gives it a natural "offshore" function, making it suitable for piloting policies that align more closely with international practice.

He proposed building on experience from the Guangdong-Hong Kong-Macau Greater Bay Area, where a program was launched in August 2021.

The program allows designated mainland hospitals to use urgently needed drugs and medical devices approved in Hong Kong or Macau but not yet accessible on the Chinese mainland.

Wu said the model has proven manageable. He revealed that medical institutions under his group in the Greater Bay Area have introduced more than 100 urgently needed drugs and devices not yet available on the mainland.

The political advisor suggested allowing qualified medical institutions in the Eastern Hub zone to import and use Hong Kong-approved drugs and devices for urgent clinical needs, with broader use of catalog-based approvals for certain products.

The "white list" may include specific vaccines, biological agents, medicines for rare diseases, implants and interventional devices, and emergency blood products.

"This would allow patients to use the world's latest life-saving drugs in Shanghai," Wu remarked. "It would attract patients to Shanghai and keep medical spending inside the country."

He said faster access to advanced drugs and devices at the Eastern Hub could support patient care, research cooperation and the growth of international medical services in Shanghai.

Zhao Yugang, deputy director of the zone's management authority, said the hub is moving ahead with dedicated medical platforms.

"We are actively promoting a global medical device innovation, exhibition, training and trading center," Zhao told Shanghai Daily in a previous interview.

He added that construction of facilities related to biomedical research, medical services and health care will begin this year.