Original Title: Notice Issued by the General Office of the Provincial Government on Several Policy Measures to Comprehensively Advance Deep-Seated Reforms in the Regulation of Drugs and Medical Devices and Promote High-Quality Development of the Pharmaceutical Industry
To thoroughly implement the "Opinions of the General Office of the State Council on Comprehensively Deepening Reforms in Drug and Medical Device Regulation to Promote High-Quality Development of the Pharmaceutical Industry" (State Council General Office Document [2024] No. 53), comprehensively advance in-depth reforms in drug and medical device regulation, and promote high-quality development of the pharmaceutical industry, the following policy measures are hereby proposed.
I. Promoting Pilot Implementation of Key Reforms
(1) Seek to Launch National Pilot Reforms. Advance pilot reforms to optimize the review and approval procedures for drug supplemental applications, aiming to reduce the review period for supplemental applications requiring verification and testing from 200 working days to 60 working days. Advance pilot reforms for segmented production of biological products and explore regulatory oversight of cross-border segmented production. Seek to launch pilot programs to optimize the review and approval of clinical trials for innovative drugs, aiming to reduce the review and approval period from 60 working days to 30 working days.Seek to establish pilot programs allowing high-level medical institutions to independently develop and use diagnostic reagents for which no equivalent products are currently marketed domestically. Seek to establish pilot programs for file-based review of generic drugs, support the accelerated registration and market launch of first-to-market generic drug varieties, and enhance the quality standards of generic drugs. Explore the launch of pilot programs for cross-border contract manufacturing of medical devices. Seek to establish pilot programs in free trade zones allowing foreign-invested enterprises to engage in the development and application of human stem cell and gene diagnosis and treatment technologies for product registration, market launch, and production.
(2) Actively explore provincial-level reform pilot programs. Support the lawful change of registration entities for active pharmaceutical ingredients (APIs); allow eligible enterprises to conduct pilot programs for segmented API production; and permit provincial pharmaceutical manufacturers to establish off-site production facilities across provincial borders. Explore and guide pilot programs for continuous drug manufacturing. Explore laboratory sharing among eligible medical device enterprises within designated regions. Explore the release of medical devices based on pre-defined parameters, and support eligible products in shortening their release cycles. Implement the “One-Stop Service” reform for relocation and change applications by pharmaceutical and medical device manufacturers.
(3) Deepen the reform of the review and inspection service system. Based on the actual needs of drug and medical device regulatory work, optimize the functions and structure of provincial-level review and inspection agencies. Promote the standardized and regulated development of review and inspection sub-centers; optimize the management of delegated authority; strengthen the independent review capabilities of sub-center staff; and delegate more review and inspection responsibilities to sub-centers based on the pharmaceutical industry conditions of prefecture-level cities.
II. Continuously Optimize Review and Approval Services
(4) Optimize Medical Device Registration and Licensing. For eligible corporate groups submitting applications in Jiangsu for products already registered domestically, technical review shall be completed within 5 working days. Simplify registration application materials for low-risk products. Implement parallel review and approval for Class II medical devices regarding pre-market registration and production licensing applications, and consolidate the processing of registration renewals and amendments.The average testing time for active medical devices will be reduced from 85 working days to 60 working days. For Class II medical devices that are the first of their kind in the country, innovative, emergency, or priority cases, priority will be given to registration testing, supplementary testing, technical review, and system verification. For medical device manufacturers with no critical non-conformities in key items and no major changes to their quality management systems within the past two years, production licenses will be issued immediately following document review.
(5) Optimize post-market change management for drugs. Implement tiered and categorized reviews, simplify procedures for low-risk matters, and reduce the review period for filing-type changes that do not involve technical research data from 30 working days to 5 working days.Strengthen the coordination between the processes for changes to drug manufacturing sites and other registration management matters. Optimize the licensing change procedures for the construction, renovation, and expansion of manufacturing sites within the same production address; for site changes that meet the requirements, licensing inspections, registration verifications, and GMP compliance inspections will be conducted concurrently.
(6) Advance the reform of integrated pharmaceutical distribution. Support marketing authorization holders and pharmaceutical wholesalers in comprehensively utilizing warehouse resources through methods such as outsourced storage and transportation, multi-warehouse coordination, and establishing warehouses in different locations to develop modern pharmaceutical logistics. Support pilot programs in free trade zones for the sharing of warehouse resources among group-based pharmaceutical enterprises integrating industry, commerce, and trade, and allow eligible subsidiaries within the group responsible for production, R&D, and operations to comprehensively utilize warehouse resources.Streamline the licensing process for retail pharmacy chains to absorb and merge independent pharmacies, enhance the convenience of modifying drug operation licenses and qualifications for designated medical insurance retail pharmacies, and increase the penetration rate of retail chains.
(7) Strengthen guidance on pre-application services and communication. Establish a communication mechanism with the Yangtze River Delta branch centers of the National Medical Products Administration (NMPA) responsible for drug evaluation and inspection, as well as medical device technical evaluation and inspection, to jointly conduct policy and technical training and guidance on innovative product submissions. In accordance with the requirements of “early intervention, tailored approaches for each enterprise, full-process guidance, and coordination between research and review,” establish a joint service mechanism among provincial-level departments and implement a list-based management system for key projects.Regularly convene “face-to-face” communication sessions between government and enterprises, and establish a “direct channel” mechanism for specialized services in key pharmaceutical parks. Develop the “Jiangsu Drug Regulatory Cloud Classroom” to provide enterprises with convenient and efficient comprehensive guidance.
III. Promoting Pharmaceutical R&D Innovation
(8) Support the R&D of innovative products. Focusing on innovation, clinically urgent needs, and treatments for rare diseases, deploy and implement a batch of provincial science and technology plan projects to support the R&D of cutting-edge pharmaceutical products—such as cell and gene therapy drugs, drugs already marketed overseas, radiopharmaceuticals, medical robots, and brain-computer interface devices—as well as breakthroughs in key raw materials and core components. Implement support policies such as “exemption from application and direct access” incentives for innovative drugs and medical devices, and capacity-building initiatives for clinical trial institutions.Establish a center for cultivating high-value patents, support the development of intellectual property operation centers for the biopharmaceutical industry, and conduct patent navigation and analysis in the pharmaceutical and medical device sectors.
(9) Promote the commercialization of scientific research achievements. Strengthen the development of regional technology transfer and commercialization centers for biomedicine at universities nationwide to facilitate the implementation of research projects. Conduct specialized research on regulatory science for pharmaceuticals and medical devices. Establish incentive mechanisms for commercialization and for researchers, accelerate reforms such as the separate management of assets derived from scientific and technological achievements generated during employment, the professional title evaluation for technology transfer personnel, and the exemption from liability for due diligence in commercialization. Encourage universities and research institutes to license scientific and technological achievements to small, medium, and micro enterprises on a “use-first, pay-later” basis.
(10) Strengthen clinical research capacity building. Work to reduce the total time required to initiate clinical trials to within 18 weeks.Encourage participating institutions in multicenter clinical research (trials) to proactively recognize the ethical review results of the lead institution, and continue to promote mutual recognition of medical ethics review results. Encourage medical institutions to improve the remuneration distribution mechanisms for clinical trial teams, and allow eligible clinical trial principal investigator projects to be treated as provincial-level research projects. Promote the sharing and application of health and medical big data resources, such as biological sample resources, to support corporate innovation research.
(11) Support the promotion and use of innovative products. Establish a green channel for the online listing of innovative drugs and medical devices, which will remain open year-round, with applications accepted and listings processed on a first-come, first-served basis, ensuring all eligible products are listed.Applications for online listing by enterprises will be processed within 15 working days of acceptance. Improve the dispute resolution mechanism for intellectual property issues during the online listing of innovative drugs and medical devices to facilitate early resolution of such disputes. Encourage the first-time procurement of self-developed innovative products. After submitting a marketing application for an innovative drug, enterprises may communicate with medical insurance and health authorities to prepare in advance for medical insurance coverage and hospital adoption.
(12) Strengthen support for medical insurance reimbursement. Based on the fund’s capacity, incorporate drugs negotiated under the National Medical Insurance Drug List into “dual-channel” management in accordance with established procedures. Support the inclusion of eligible cases involving the use of innovative drugs and medical devices in special case negotiations. Promote the application of medical insurance data to facilitate rapid claims settlement for inclusive commercial health insurance. Funds from employees’ medical insurance personal accounts may be used to purchase eligible inclusive commercial health insurance products for close relatives.
IV. Supporting the Inheritance and Innovative Development of Traditional Chinese Medicine
(13) Strengthen the development of standards and regulations for traditional Chinese medicine. Optimize the process for formulating and revising provincial-level standards for traditional Chinese medicine. Advance the implementation of the “Good Agricultural and Collection Practices for Chinese Medicinal Materials.” Establish procedures for the filing of custom processing of traditional Chinese medicine decoction pieces in Jiangsu Province, and promote the filing of processing techniques for decoction pieces with special clinical needs, as well as their inclusion in processing standards. Support the inclusion of eligible traditional Chinese medicine decoction pieces and granulated herbal formulas in the scope of medical insurance fund coverage.
(14) Support the Inheritance and Development of Traditional Chinese Medicine Schools of Thought. Support the exploration, protection, and inheritance of traditional Chinese medicine schools of thought such as the Wumen School, Menghe School, Longsha School, and Chengjiang Acupuncture School. Establish a database of formulas and medicines from these schools, and promote the transformation of academic achievements—such as distinctive processing techniques and agreed-upon prescriptions—into clinical prescription processing filings, processing standards, medical institution preparations, and classic formulas.Revise the implementation rules for the registration and filing of medical institution preparations; optimize the mechanism for the standardized collection of empirical data on human use by medical institutions; and explore the use of empirical data on human use and academic achievements of schools to conduct technical reviews and evaluations of TCM preparations produced by medical institutions.
(15) Promote the application and commercialization of new TCM drugs.Support the establishment of regional TCM preparation centers and facilitate the intra-provincial distribution of TCM preparations for medical institutions that are urgently needed for clinical use or for new drug R&D. Advance the construction of the Provincial Center for TCM Integration and Innovation, conduct the selection of “Famous Jiangsu Formulas” among TCM preparations for medical institutions, and support the transformation of formulas from renowned senior TCM practitioners and TCM preparations for medical institutions into new TCM drugs. Support the secondary development of proprietary Chinese medicine products, and exempt those that meet the conditions for protection from on-site inspections.
V. Expanding High-Level Opening-Up
(16) Strengthen support for product exports. Cooperate with the National Medical Products Administration to accelerate the process of joining the International Pharmaceutical Inspection Cooperation Scheme (PIIC) and promote mutual recognition of regulatory standards and results among member states. Encourage medical institutions within the province to conduct international multi-center clinical trials and support enterprises in carrying out high-level clinical trial projects overseas. Streamline the processing of export service procedures for pharmaceuticals and medical devices and expand the scope of issuance for export sales certificates.
(17) Optimize the import of goods in the pharmaceutical sector. Seek to expand the scope of functions at drug import ports.The Suzhou Industrial Park will adopt the national integrated customs clearance model for drug imports, allowing enterprises to obtain drug clearance documents locally and complete import customs clearance and release procedures at the Shanghai Customs. We will optimize the “whitelist” system for the import of items used in biopharmaceutical R&D based on enterprise creditworthiness and promote mutual recognition within the province. For commercial-scale batches of imported drugs already marketed overseas that meet national requirements, port drug regulatory authorities will issue import clearance documents in accordance with the law.
(18) Support the domestic registration and production of products already marketed overseas. Support foreign-invested enterprises in introducing original-research pharmaceuticals and high-end medical equipment for production in Jiangsu, and coordinate efforts to advance the review and approval process for the conversion of original-research pharmaceuticals from imported to domestically produced status. Support imported pharmaceuticals and medical consumables converted to domestic production in obtaining equivalence to imported products for clinical use. Optimize import declaration procedures for medical device components and validation samples, simplify procedures for the return of exported medical devices for factory repairs, and allow enterprises to reference the original export clearance procedures.
VI. Enhancing Modern Regulatory Capabilities
(19) Improve the regulatory system. Promote amendments to the “Jiangsu Province Drug Supervision and Administration Regulations.” Improve the drug safety accountability system, strengthen interdepartmental, interregional, and inter-level regulatory coordination, and optimize the evaluation mechanism for standardizing drug regulatory capabilities at the municipal and county levels. Strengthen efforts to promote enterprises’ implementation of their primary responsibility for quality and safety through legal education, and establish a tiered evaluation system for enterprises’ fulfillment of this responsibility. Actively participate in the National Standard Improvement Action Plan, and encourage enterprises to adopt technical standards and engage in international cooperation.
(20) Enhance Smart Regulatory Capabilities. Improve the comprehensive smart drug regulatory platform; explore the establishment of a trusted data space for drug regulation; and strengthen the interoperability, sharing, and scenario-based application of regulatory data. Accelerate the construction of a full-process traceability system for drugs and medical devices. Support drug and medical device enterprises in accelerating the implementation of “intelligent transformation, digital transition, and network connectivity,” and cultivate a batch of advanced, excellent, and leading-edge smart factories through categorized development. Promote pilot projects for the integrated development of smart manufacturing and smart regulation in the medical device sector.
(21) Enhance review and inspection capabilities. Strengthen the development of provincial-level review teams, accelerate the training of expert-level reviewers, establish a database of technical review experts, and enhance the review service capabilities of the National Medical Products Administration’s Medical Device Innovation Service Stations. Strengthen the development of a professional and specialized inspectorate, optimize the team structure, and increase efforts to cultivate high-quality talent, including inspection team leaders, national-level inspectors, and overseas inspectors.
(22) Enhance testing and monitoring capabilities. Implement projects to enhance batch release capabilities for biological products such as vaccines, and strive to expand the scope of authorization for vaccine batch release.Advance the construction of testing platforms in emerging fields such as brain-computer interfaces and artificial organs, and develop leading testing programs in the field of medical electroacoustics. Based on industry needs, continue to promote the establishment of provincial-level drug and medical device testing and inspection facilities, and encourage regions with the necessary conditions to integrate existing resources to establish municipal-level drug and medical device testing and inspection institutions. Improve the monitoring networks for adverse drug reactions and adverse medical device events, strengthen the construction and management of sentinel hospitals, and reinforce the role of medical institutions as the primary reporting channel.
(23) Strengthen the talent pool for the industry. Expand the ranks of highly qualified and specialized technical personnel in the pharmaceutical and medical device sectors; intensify efforts to recruit and cultivate high-level professionals; improve talent incentive mechanisms; and provide personalized training and development opportunities for technical personnel at all levels. Set a higher proportion of senior professional technical positions in technical institutions responsible for review, inspection, testing, and monitoring.
This document shall take effect on August 12, 2025, and remain valid until August 11, 2030.
