Promoting High-Quality Innovative Development of Drugs and Medical Devices with High-Level Safety - Regulations of Shanghai Municipality on Drug and Medical Device Administration Effective on March 1 This Year
As the first local regulation in China to comprehensively standardize the R&D, production, operation, and use of drugs and medical devices, the Regulations of Shanghai Municipality on Drug and Medical Device Administration (hereinafter referred to as the “Regulations”) adopted by vote at the 18th meeting of the Standing Committee of the 16th Shanghai Municipal People’s Congress on December 31, 2024 will come into effect on March 1, 2025.
(I) Defining clinical value orientation and enhancing R&D innovation quality and efficiency
To promote R&D innovation and accelerate the marketing of innovative drugs and medical devices, the Regulations stipulate as follows: firstly, Shanghai encourages innovative R&D oriented toward clinical value and the integration and sharing of resources to drive the transformation, promotion, and application of new technologies; secondly, Shanghai clarifies clinical trial requirements and encourages multi-center clinical trials across different countries or regions to support faster marketing and “going global” of products; thirdly, the municipal medical products administration shall strengthen pre-registration guidance for drugs and medical devices with significant clinical value and strong innovativeness; and fourthly, Shanghai supports relevant entities in cooperating in clinical trials of cell and gene therapy drugs and encourages the development and purchase of insurance products covering such clinical trials.
(II) Addressing development difficulties and bottlenecks and improving relevant management systems
In response to difficulties and bottlenecks in practice, the Regulations have improved management systems and service models and formed corresponding measures: firstly, the Regulations define management requirements for entrusted production of drugs and medical devices, transfer of medical devices into local production, and shared use of medical device production facilities and equipment; secondly, the Regulations state that Shanghai explores the staged entrusted production of drugs and the commercial-scale batch marketing of drugs according to national provisions, and the municipal medical products administration shall strengthen regulation; thirdly, the Regulations specify management measures for affixing Chinese labels to imported medical devices in the China (Shanghai) Pilot Free Trade Zone and Lin-gang Special Area; fourthly, the Regulations stipulate that manufacturers of Chinese medicinal materials shall extend their quality management systems to planting, harvesting, processing, and other links to ensure the quality of traditional Chinese medicine decoction pieces at source; and fifthly, the Regulations specify special requirements for cell and gene therapy drugs in production, operation, and use to support enterprises in gaining advantages in global sci-tech and industrial competition.
(III) Guarding the safety bottom line and building a collaborative governance system
To ensure the quality and safety of drugs and medical devices and to create a synergy in governance, the Regulations stipulate that a “three-in-one” safety responsibility system involving the territorial responsibilities of the locality, the regulatory responsibilities of competent authorities, and the primary responsibilities of enterprises shall be established; secondly, categorized, joint, and smart regulation shall be implemented to enhance professional regulatory capabilities; thirdly, oversight of online transactions shall be strengthened and regulation of online platform operators and related online sales enterprises for drugs and medical devices shall be enhanced; fourthly, drug regulators shall conduct sampling evaluations of quality status and assessments of production quality management systems for specific categories of drugs and medical devices and for innovative drugs and medical devices; and fifthly, the municipal medical products administration shall establish a monitoring network for adverse drug reactions and adverse events associated with medical devices and strengthen the construction of monitoring sites to promptly identify and control safety risks.
Source: Shanghai Municipal People’s Congress
As the first local regulation in China to comprehensively standardize the R&D, production, operation, and use of drugs and medical devices, the Regulations of Shanghai Municipality on Drug and Medical Device Administration (hereinafter referred to as the “Regulations”) adopted by vote at the 18th meeting of the Standing Committee of the 16th Shanghai Municipal People’s Congress on December 31, 2024 will come into effect on March 1, 2025.
Legislative Background
Drugs and medical devices are directly related to people’s lives and health. The Report to the 20th National Congress of the Communist Party of China (CPC) stated tightening supervision over drug safety and advancing the Healthy China Initiative. The Third Plenary Session of the 20th CPC Central Committee emphasized refining the drug safety responsibility system and improving the mechanisms for supporting the development of innovative drugs and medical equipment. In recent years, Shanghai has introduced a series of policy documents and initiatives aimed at building a highland and innovation engine with international influence for the biomedical industry. To further implement the decisions and arrangements of the CPC Central Committee, Shanghai deemed it necessary to formulate local regulations for drug and medical device administration, thereby meeting people’s demand for high-quality drugs and medical devices and boosting the building of a Healthy China.
Main Content
The Regulations coordinate development and safety, ensure the primary responsibilities of relevant parties throughout the lifecycle management of drugs and medical devices, and promote the high-quality innovative development thereof with high-level safety. The Regulations emphasize both regulation and service, advance the transformation of regulatory concepts and methods, strengthen targeted and coordinated services, and guard the bottom line of drug and medical device safety. The Regulations consist of 54 articles in seven chapters, with the main provisions as follows:(I) Defining clinical value orientation and enhancing R&D innovation quality and efficiency
To promote R&D innovation and accelerate the marketing of innovative drugs and medical devices, the Regulations stipulate as follows: firstly, Shanghai encourages innovative R&D oriented toward clinical value and the integration and sharing of resources to drive the transformation, promotion, and application of new technologies; secondly, Shanghai clarifies clinical trial requirements and encourages multi-center clinical trials across different countries or regions to support faster marketing and “going global” of products; thirdly, the municipal medical products administration shall strengthen pre-registration guidance for drugs and medical devices with significant clinical value and strong innovativeness; and fourthly, Shanghai supports relevant entities in cooperating in clinical trials of cell and gene therapy drugs and encourages the development and purchase of insurance products covering such clinical trials.
(II) Addressing development difficulties and bottlenecks and improving relevant management systems
In response to difficulties and bottlenecks in practice, the Regulations have improved management systems and service models and formed corresponding measures: firstly, the Regulations define management requirements for entrusted production of drugs and medical devices, transfer of medical devices into local production, and shared use of medical device production facilities and equipment; secondly, the Regulations state that Shanghai explores the staged entrusted production of drugs and the commercial-scale batch marketing of drugs according to national provisions, and the municipal medical products administration shall strengthen regulation; thirdly, the Regulations specify management measures for affixing Chinese labels to imported medical devices in the China (Shanghai) Pilot Free Trade Zone and Lin-gang Special Area; fourthly, the Regulations stipulate that manufacturers of Chinese medicinal materials shall extend their quality management systems to planting, harvesting, processing, and other links to ensure the quality of traditional Chinese medicine decoction pieces at source; and fifthly, the Regulations specify special requirements for cell and gene therapy drugs in production, operation, and use to support enterprises in gaining advantages in global sci-tech and industrial competition.
(III) Guarding the safety bottom line and building a collaborative governance system
To ensure the quality and safety of drugs and medical devices and to create a synergy in governance, the Regulations stipulate that a “three-in-one” safety responsibility system involving the territorial responsibilities of the locality, the regulatory responsibilities of competent authorities, and the primary responsibilities of enterprises shall be established; secondly, categorized, joint, and smart regulation shall be implemented to enhance professional regulatory capabilities; thirdly, oversight of online transactions shall be strengthened and regulation of online platform operators and related online sales enterprises for drugs and medical devices shall be enhanced; fourthly, drug regulators shall conduct sampling evaluations of quality status and assessments of production quality management systems for specific categories of drugs and medical devices and for innovative drugs and medical devices; and fifthly, the municipal medical products administration shall establish a monitoring network for adverse drug reactions and adverse events associated with medical devices and strengthen the construction of monitoring sites to promptly identify and control safety risks.
Source: Shanghai Municipal People’s Congress