Shanghai launches reforms to accelerate biomedical industry's growth

Shanghai has recently announced reforms to streamline drug and medical device regulations, aiming to accelerate the high-quality development of its biomedical industry, local officials said on Wednesday.

The reforms, aligned with the State Council directives on pharmaceutical industry development, target faster approval processes, innovation promotion, and enhanced regulatory compliance, according to Guo Shuting, deputy director of Shanghai Municipal Drug Administration.

"These initiatives mark an advance in Shanghai's journey toward becoming a world-leading area in the biomedical industry," Guo said. "We're working to create an environment that attracts leading enterprises, investment, and talent from home and abroad through accelerated reviews and enhanced policy frameworks."

Key initiatives include reducing eligible innovative drug clinical trial approvals to 30 working days and streamlining seasonal influenza vaccine lot releases to the same time frame. The initial registrations of Class II medical devices will be completed within six months on average.

The city is launching pilot programs for overseas drug and generic drug reviews to speed up market access. Pilot schemes for the biological product segment production and cross-border manufacturing will be launched for major foreign investments.

To boost innovation, Shanghai will create traditional Chinese medicine transformation platforms connecting medical institutions, research centers, and pharmaceutical companies. Enhanced registration guidance services will provide comprehensive support throughout the product development cycle.

The reforms facilitate international multicenter clinical trials and support domestic pharmaceutical companies' global market entry through internationally recognized inspection services.

The reform package covers six strategic areas, namely R&D innovation support, deepening national reform pilot programs, approval efficiency improvements, international cooperation expansion, life cycle supervision, and regulatory capacity enhancement, Zhao Yanjun, deputy director of Shanghai Municipal Drug Administration, said.

Shanghai is also pioneering healthcare insurance reforms, establishing fast-track procedures for innovative products on medical procurement platforms, and expanding commercial insurance coverage to improve accessibility.

The municipal health commission is enhancing clinical research ethical reviews and facilitating patent commercialization from medical institutions through a streamlined submission process.

The city's intellectual property protection system has processed over 3,700 drug and medical device patent pre-examinations, reducing the average patent authorization period to three months.