Shanghai has introduced a comprehensive package of policies to accelerate the development, review, and commercialization of innovative drugs and medical devices, strengthening its role as an international hub for life-science innovation and regulatory cooperation.

The new measures promote faster approval pathways for breakthrough therapies, support the generation of real-world evidence, and expand multicenter clinical trials involving domestic and overseas institutions, enabling companies to bring innovative products to market with greater efficiency and predictability.

To enhance global alignment, Shanghai will facilitate World Health Organization prequalification, encourage adoption of international standards, and promote cross-border collaboration on high-quality medical technologies, helping local innovators access overseas markets while attracting foreign enterprises to pilot products in the city.

The policy package also reinforces full-chain services for biopharmaceutical companies by improving intellectual property protection, advancing data-driven supervision, and expanding support for high-value clinical research platforms across hospitals, industrial parks, and research institutes.

Reforms to ethics reviews will streamline multi-site approvals, strengthen oversight of emerging technologies, and promote unified digital systems to increase transparency and reduce delays for clinical trials involving innovative therapies, medical devices, and artificial intelligence applications.

To support commercialization, Shanghai will deepen cooperation with national medical insurance authorities, promote value-based purchasing mechanisms, and encourage commercial insurance participation to improve patient access to advanced medicines and devices.

With these initiatives, Shanghai aims to build a globally competitive regulatory ecosystem that integrates innovation, safety, efficiency, and international openness, further elevating its position as a leading biomedical innovation center.

Source: Shanghai Intellectual Property Administration