Measures to Support the Implementation of High-Caliber Projects by Foreign-Invested Biomedical Enterprises (Concise Version)

Purpose

With a view to effectively facilitating the implementation of high-caliber projects by foreign-invested biomedical enterprises with large investment, high innovation intensity, strong driving effects, and broad industry influence, the following measures are hereby proposed.

Supported Entities & Distribution Optimization

01 Supporting the Launch of Diverse High-Caliber Projects

· Foreign-invested biomedical enterprises are supported in establishing various functional operations in Shanghai, and international organizations are encouraged to set up operations in the city. Policy incentives, factor guarantees, and full-cycle services are strengthened to help such enterprises consolidate their status as core hubs for global resource allocation.

02 Optimizing the Distribution of High-Caliber Projects

· Pudong New Area continues to strengthen the “Zhangjiang Pharma Valley” brand, aiming to build a global strategic cluster of multinational pharmaceutical and medical device companies, fully leveraging its strategic advantages as a National Leading Area, a Pilot Free Trade Zone and a Comprehensive Reform Pilot Area.

· Minhang District focuses on developing a high-end manufacturing cluster for foreign-invested enterprises (FIEs) based on the Hongqiao International Open Hub.

· Jing’an District converges the high-level headquarters of FIEs, leveraging its advantages as a highly internationalized district in central Shanghai.

· Coordination between municipal and district levels is strengthened and key areas are paired up to strengthen the sharing and complementarity of resources. Targeted services are provided to ensure the rational cross-district distribution of R&D, manufacturing, headquarters, and other functions.

Full-Chain Support for the Implementation of High-Caliber Projects

03 Facilitating the Implementation of High-End Industrial Projects

· Industrial projects characterized by cutting-edge technologies and strong driving effects are included in the Municipal List of Major Foreign-Invested Projects, and their inclusion in the National List of Major and Key Foreign-Invested Projects is actively recommended.

· One-stop services are provided to coordinate procedures regarding market access, planning, environmental protection, land use, premises, energy consumption, construction, foreign exchange, and import and export.

· Projects that qualify as major municipal engineering projects are incorporated into the municipal coordinated implementation mechanism to facilitate their execution.

04 Facilitating the Upgrading of Manufacturing Projects

· FIEs are encouraged to accelerate the transformation and upgrading of their production lines and equipment. Support is provided for the development or iterative upgrading of smart, green, integrated, and high-end manufacturing projects. Such support is granted to eligible projects in accordance with applicable regulations.

05 Supporting the Localization of Licensed-In Projects

· Full-chain services are provided to reduce the comprehensive costs of project implementation. These services include streamlined environmental impact assessments, proactive regulatory review and approval, clinical resource alignment, shared incubator platforms, communication with contract development and manufacturing organization (CDMO), tailored industrial park services, and investment and financing matchmaking.

· Contract manufacturing organizations (CMOs) and manufacturers are encouraged to undertake commissioned production, and eligible entities will receive support in accordance with applicable regulations.

06 Supporting the Localization of Imported Drugs and Medical Devices

· Comprehensive support is provided throughout the entire lifecycle, from land acquisition and construction commencement to applications for manufacturing changes, marketing authorization, distribution, and sales, aiming to enhance the efficiency of project implementation.

· Medical device products that have obtained a domestic registration certificate (approval number) from the medical products regulatory authority are permitted to participate in procurement activities as domestically manufactured products.

07 Strengthening the Capacity of Foreign-Invested R&D Centers

· Support is provided for the establishment of global R&D centers, open innovation platforms, proof-of-concept centers, and generic technology platforms. High-tech achievements by these entities are eligible for recognition as projects for the commercialization of high-tech achievement in accordance with applicable regulations

· FIEs are encouraged to collaborate with local universities, research institutes, medical institutions, and innovative enterprises on R&D and industrial application of frontier technologies and future industries. Foreign-funded R&D institutions are supported in applying for collaborative innovation projects.

· The establishment of postdoctoral research workstations is encouraged.

08 Supporting the Upgrading and Functional Improvement of Headquarters

· Enterprise headquarters are encouraged to consolidate functions—including R&D innovation, treasury management, investment decision-making, procurement and distribution, supply chain management, and shared services—and to upgrade into higher-tier headquarters such as Asia-Pacific headquarters or global business unit headquarters. Rewards are granted to eligible initiatives.

Optimizing Resource Allocation for High-Caliber Projects

09 Strengthening Capabilities of Multi-Regional Clinical Trials (MRCTs)

· More principal investigators (PIs) with international influence are nurtured to support the conduct of MRCTs.

· Support is prioritized for projects that take the lead in the completion of MRCTs.

10 Optimizing the Utilization of Clinical Resources

· The alignment of clinical resources—including Shanghai’s hospital-based clinical research support platforms, clinical cohort databases, and research wards/beds—with high-caliber projects is advanced, and clinical research contributions to the biomedical industry are integrated into the routine performance monitoring of municipal hospitals.

· Parallel review processes for project initiation, ethics approval, and contract execution are implemented to shorten clinical trial lead times.

11 Providing Regulatory Services and Guidance for Drugs and Medical Devices

· Clinical trials, manufacturing licensing, marketing authorization, and inspections for products of high-caliber projects are accelerated through early intervention, proactive engagement, and dedicated task force support.

· Eligible overseas marketing authorization holders (MAHs) are supported in conducting cross-border, multi-jurisdiction manufacturing of biological products.

· Multinational enterprises in Shanghai are supported in becoming MAHs and obtaining drug manufacturing licenses via contract manufacturing.

· Communication with National Medical Products Administration (NMPA) is strengthened by leveraging the role of the Yangtze River Delta Center for Drug Evaluation and Inspection and the Yangtze River Delta Center for Medical Device Evaluation and Inspection of NMPA, and comprehensive guidance services are provided for enterprises.

12 Streamlining Review and Inspection Workflows

· Priority is given to registration sampling and Good Manufacturing Practice (GMP) compliance inspections for imported products already on the market that are transitioning to local production. Registration verification and GMP compliance inspections are coordinated to be conducted concurrently.

· Measures such as “pre-review and pre-inspection,” “fully online processing,” and “immediate review upon submission” are promoted. The transition is made from sequential processing to parallel processing for evaluation, review, and inspection procedures, and for interrelated matters, joint review and processing are implemented.

13 Optimizing Medical Device Registration and Inspection Procedures

· Registration documentation requirements and production site inspection procedures are optimized for Class II medical devices transferred to manufacturing in Shanghai. For product varieties applying for batch transfers, centralized reviews are implemented, and on-site inspections are consolidated or waived. Where all requirements are met, technical review is completed within 5 working days.

· Pre-submission review services are provided for Class II and Class III innovative medical device applications, covering both initial submissions and responses to deficiency letters. The average timeframe for first-time registration of Class II medical devices is reduced to within 6 months.

14 Accelerating the Sales and Distribution of Imported Drugs

· For overseas-approved drugs that have obtained a domestic drug approval certificate, market sale is permitted for batches manufactured prior to approval, provided they meet the required standards for drug release.

· Integrated customs clearance and sampling procedures, along with 24-hour clearance operations, are implemented.

· Lot release testing for biological products and customs clearance testing for imported drugs are expedited. Sampling shall be completed within 3 working days of port arrival, and the sample volume per batch shall be reduced from triple to double the amount required for full testing.

15 Supporting the Inclusion of High-Value Drugs and Medical Devices in the Multi-Payer Payment System

· The inclusion of relevant products in the coverage of commercial health insurance schemes, such as Shanghai’s “Hu Hui Bao,” is supported.

· Applications for demonstration projects involving innovative drugs and devices are supported, as are real-world studies. The findings of such studies may be considered for informing the pricing of medical insurance and commercial health plans.

16 Facilitating the Adoption of High-Value Drugs and Medical Devices in Hospitals

· The inclusion of eligible high-value drugs and medical devices in the “New and Superior Drugs and Medical Devices” catalog is supported.

· For marketed imported products transitioning to domestic manufacturing, their status as Reference Listed Drugs (RLDs) is retained, and neither listing prices nor hospital formulary access is adversely affected.

17 Expanding Application Scenarios for High-Value Innovative Drugs and Medical Devices

· International medical institutions are encouraged to adopt “New and Superior Drugs and Medical Devices” products and advanced treatment technologies, such as cell, gene, and particle therapies.

· Exhibition and training centers for innovative drugs and medical devices are established in the Eastern Hub International Business Cooperation Zone and the Hongqiao International Central Business District.

18 Optimizing Customs Clearance and Regulatory Procedures for Materials

· Facilitated customs clearance for imported items used in R&D is supported in accordance with relevant management procedures.

· The joint cross-border regulatory mechanism for special articles is leveraged to facilitate the import and export of high-risk special items required for the R&D and production of products, such as cell therapy products and in vitro diagnostic (IVD) reagents.

19 Promoting Lawful Cross-Border Data Flows

· Citywide implementation of the negative-list mechanism for outbound data transfers is accelerated.

· Training and guidance on the lawful outbound transfer of data, such as R&D data from FIEs and clinical study data, are strengthened.

20 Supporting the Integration of Foreign-Capital Funds into Local Innovation

· FIEs are encouraged to establish venture capital funds, technology commercialization funds, and private equity funds in Shanghai.

· FIEs are supported in collaborating with state-owned capital funds, such as the Shanghai Biomedical Pioneer Industry Mother Fund and the Shanghai Future Industry Fund, to establish sub-funds.

21 Encouraging Foreign-Invested Enterprises to Expand Investment

· Biomedical projects funded by FIEs or their reinvested enterprises within China may, in accordance with regulations, qualify for the tariff exemption policy for imported self‑use equipment.

· The policies of tax credits and temporary exemption from withholding tax for foreign investors reinvesting distributed profits shall be thoroughly implemented.

22 Further Strengthening the Fast-Track Coordinated Protection of Intellectual Property Rights (IPR)

·The layout of IPR protection centers is optimized, and a one-stop integrated service platform shall be established that integrates accelerated examination, IPR confirmation, and IPR protection.

Promoting High-Standard Institutional Opening-Up

23 Promoting the Development and Application of New Biomedical Technologies

· FIEs are permitted to develop and apply human stem cell technologies and gene diagnosis and therapy technologies in the Pilot Free Trade Zone.

· An innovative, tiered and classified risk management model for new biomedical technologies shall be explored to accelerate their clinical research, translational research, and clinical application.

24 Expanding the Clinical Application of Imported Drugs and Medical Devices

· The lawful temporary import of small quantities of clinically urgent drugs and devices that have obtained overseas registration certificates but not yet domestic ones is supported, as is their use in designated medical institutions.

· Greater institutional openness in market access is promoted in the Eastern Hub International Business Cooperation Zone.

Strengthening Service Guarantees for High-Caliber Projects

25 Enhancing the Service Mechanism for High-Caliber Projects

· A municipal-level service mechanism for high-caliber projects is established and improved, coordination between municipal and district authorities is strengthened and targeted government-enterprise communication and coordination is enhanced to intensify policy support.

· Industrial projects with a total investment of RMB 1 billion or more are included in the “direct access” mechanism for multinational corporations.

Policy Validity Period: This policy takes effect on the date of issuance and remains valid until June 21, 2029.