China Shanghai Updates Pharmaceutical and Medical Device Regulations for 2025
The Shanghai Municipal People's Congress has approved comprehensive updates to its Pharmaceutical and Medical Device Supervision and Administration Regulations, marking a significant step in modernizing the city's healthcare regulatory framework. The new regulations, passed on December 31, 2024, will take effect on March 1, 2025.
These updated regulations aim to strengthen the management of pharmaceuticals and medical devices while promoting innovation in the healthcare sector. The regulations emphasize a risk-based, science-driven approach to regulation while encouraging industry development and ensuring public health safety.
A key focus of the new regulations is the support for research and development in the biomedical sector. The regulations establish streamlined procedures for clinical trials, particularly for innovative drugs and medical devices, while maintaining rigorous safety standards. They also introduce new measures to facilitate the registration process for innovative medical products, especially those addressing unmet clinical needs.
The regulations also emphasize digital transformation in regulatory oversight, establishing new platforms for digital supervision and smart regulatory systems. This includes enhanced tracking systems for pharmaceutical products and medical devices throughout their lifecycle, from development to market use.
Quality management receives significant attention, with strengthened oversight of production and distribution processes. Special provisions are included for emerging technologies like cell therapy products and traditional Chinese medicine, reflecting Shanghai's comprehensive approach to healthcare regulation.
The new framework also promotes regional cooperation, particularly within the Yangtze River Delta region, and facilitates international exchanges. This aims to position Shanghai as a leading global biomedical innovation hub while maintaining high standards for product safety and quality.
These regulations represent Shanghai's commitment to modernizing its healthcare regulatory system while balancing innovation support with safety oversight, setting new standards for pharmaceutical and medical device regulation in China.