The Standing Committee of the Shanghai Municipal People’s Congress has approved and released the “Regulations on the Administration of Drugs and Medical Devices in Shanghai,” which will come into force as of March 1, 2025. These regulations are set to govern the research, production, operation, use, and supervision and management activities of drugs and medical devices within Shanghai’s administrative area.
Promoting Regional and International Cooperation
The document emphasizes Shanghai’s commitment to supporting exchanges, cooperation, and coordinated development in the fields of drugs and medical devices with other regions in China. It also highlights the city’s efforts to strengthen international exchanges and cooperation, with the aim of promoting research and development innovation and the industrial internationalization of drugs and medical devices.
Intellectual Property Protection and Rapid Patent Examination Mechanism
Shanghai is enhancing the intellectual property protection of drugs and medical devices and improving the patent rapid examination service mechanism for innovative drugs and medical devices. This encouragement of innovative research and development is a key aspect of the new regulations. In the event of a public health emergency, the municipal drug regulatory department is directed to include second-class medical devices that are urgently needed and not yet marketed domestically, or that are insufficient to meet the emergency response needs, in the emergency registration procedure.
Segmented Commissioned Production for Innovative Drugs
Shanghai will explore the implementation of segmented commissioned production for innovative drugs with special production process and equipment requirements, drugs urgently needed in clinical practice, or drugs urgently needed for responding to public health emergencies. This approach is designed to ensure the availability of critical medications during times of high demand.
Encouraging Pharmacist Engagement in Community Drug Safety Services
The regulations also encourage licensed pharmacists to join the community drug safety digital service platform and provide public pharmaceutical services to the public. This initiative aims to enhance drug safety and accessibility within communities.-Fineline Info & Tech
