Original Title: Notice on the Issuance of the "Several Measures of Songjiang District, Shanghai, Regarding the Integrated Development of the Biopharmaceutical and Life Sciences Industries"
To All Relevant Departments:
To further promote the high-quality development of the biopharmaceutical industry in Songjiang, the Shanghai Songjiang District Market Supervision Administration and seven other departments have formulated the "Several Measures of Songjiang District, Shanghai, on Serving the Integrated Development of the Biopharmaceutical and Life Sciences Industries." These measures are hereby issued for your implementation.
Attachment: Several Measures of Songjiang District, Shanghai, Regarding the Integrated Development of the Biopharmaceutical and Life Sciences Industries
Shanghai Songjiang District Market Supervision Administration
Shanghai Songjiang District Economic Commission
Shanghai Songjiang District Science and Technology Commission
Shanghai Songjiang District Health Commission
Shanghai Songjiang District Human Resources and Social Security Bureau
Shanghai Songjiang District Medical Security Bureau
Shanghai Songjiang District Civil Affairs Bureau
Shanghai Songjiang District Federation of Persons with Disabilities
May 12, 2023
Several Measures of Songjiang District, Shanghai, Regarding the Integrated Development of the Biomedical and Life Sciences Industries
To further promote the high-quality development of the biopharmaceutical industry in Songjiang, the District Market Supervision Bureau, in collaboration with relevant departments, has optimized institutional frameworks, deepened resource sharing, and accelerated the creation of a hub for biopharmaceutical innovation, high-end manufacturing, talent aggregation, and policy support. The following measures have been formulated.
I. Deepen Interdepartmental Coordination to Build a Sound Service Ecosystem for Industrial Development
(1) Establishing External Linkages: Departments Collaborate to Create a “Comprehensive Package” of Optimized Services
The District Market Supervision Bureau, in collaboration with key government departments involved in the development of the biopharmaceutical industry, will formulate and implement targeted measures to serve the district’s biopharmaceutical sector based on the industrial areas corresponding to each department’s functions. A comprehensive service platform for pharmaceutical products will be established in conjunction with municipal medical insurance authorities. This platform will provide policy interpretation and operational consultation services to local biopharmaceutical enterprises regarding matters such as drug and medical device registration, online procurement, and inclusion in medical insurance coverage, thereby facilitating the rapid clinical application of innovative pharmaceutical products;To advance the clinical application of innovative products, medical institutions are encouraged to prioritize the procurement and use of high-quality innovative products from local enterprises, provided such actions are lawful and compliant. In line with the requirements for high-quality development of public hospitals, pilot units for high-quality development in public hospitals are encouraged to collaborate with enterprises on clinical research and the commercialization of medical and scientific achievements;Integrate upstream and downstream resources across the regional biopharmaceutical industry chain to build a resilient biopharmaceutical industrial and supply chain system, and foster innovation entities such as enterprise technology centers and specialized, refined, distinctive, and innovative enterprises in the biopharmaceutical sector; actively cultivate “high-tech” enterprises, “science and technology small giants,” and industrial innovation clusters in the biopharmaceutical sector; actively implement and enforce municipal and district-level policies and services regarding talent recruitment and subsidies to assist biopharmaceutical enterprises in attracting urgently needed talent and college graduates;Collaborate with relevant competent authorities to foster social organizations in the biopharmaceutical sector, promoting the application of high-quality regional products in the elderly care industry; guided by the needs of persons with disabilities, strengthen R&D cooperation and product application with local manufacturers of rehabilitation assistive devices. (District Medical Insurance Bureau, District Health Commission, District Economic Commission, District Science and Technology Commission, District Human Resources and Social Security Bureau, District Civil Affairs Bureau, District Disabled Persons’ Federation)
(2) Strengthen Internal Coordination to Ensure All Departments Are in Sync and Deliver the “Strongest Voice” in Market Regulation Services
Leverage the protective and supportive role of intellectual property rights to provide a “green channel” for patent fast-track examination, rapid rights confirmation, and expedited rights protection for enterprises in the biopharmaceutical industry;Implement standard-led development by guiding and assisting qualified biomedical entities in participating in the formulation of international, national, and industry standards, and encouraging enterprises to actively undertake national and municipal standardization pilot projects; integrate metrology and testing into product R&D and manufacturing to enhance development efficiency, facilitate mass production, and boost core competitiveness; refine quality and brand incentive policies to encourage leading pharmaceutical enterprises and industry benchmark companies to compete for government quality awards, and cultivate quality demonstration enterprises. (District Market Regulation Bureau)
II. Expanding Service Areas and Extending Our Reach to Subdistricts, Towns, and Industrial Parks
(3) Expand the Service Coverage of Biopharmaceutical Registration Guidance Service Stations
Leverage life and health industry projects to expand service coverage to pharmaceuticals, medical devices, and cosmetics; guide the parallel development of cross-sectoral products or related industries within the same enterprise. Integrate related entities—such as medical institutions, key raw material suppliers, production equipment providers, facility construction firms, and medium-to-large-scale operating enterprises—into the biopharmaceutical industry ecosystem, and organize activities including technological innovation collaboration, clinical research services, and policy and regulatory training. (District Market Supervision Bureau, District Economic Commission)
(4) Establishing Sub-district and Town-Level Biopharmaceutical Product Registration Service Guidance Points
Building upon the existing medical device industrial park, establish biomedical product registration service guidance stations upon request, and cultivate a team of on-site registration and filing service specialists to provide regular consultation services to enterprises; guide each sub-district and town to establish “face-to-face” liaison service mechanisms, conduct follow-up services for key enterprises and projects, and resolve bottlenecks and challenges encountered during enterprise project development;Through surveys conducted by service stations and self-reports from enterprises and parks, establish and regularly update a list of shareable resources within the regional biopharmaceutical industry. Mobilize local biopharmaceutical R&D and production resources—including cleanrooms, idle equipment, and surplus production and testing capacity—to facilitate effective supply-demand matching. (District Market Supervision Bureau, District Economic Commission, relevant sub-districts, towns, and parks)
(5) Cultivating Biopharmaceutical Industry Demonstration Parks and Leading Enterprises
Establish a cross-town cooperation mechanism for biopharmaceutical industrial parks, strengthen coordination between towns and districts, guide the spatial planning and layout of the biopharmaceutical industry, rationally locate specialized industrial parks and production bases, fill gaps in the biopharmaceutical industrial chain, and form a demonstration zone for shared development in the biopharmaceutical industry; high-quality advancement of the municipal-level specialized park G60 Biopharmaceutical Industry Base; cultivate technology-driven and market-led leading enterprises. (District Market Supervision Bureau, District Economic Commission, District Science and Technology Commission, relevant towns, sub-districts, and industrial parks)
III. Establish Diverse Platforms and Provide Targeted Services Focused on Market Needs
(6) Deepen Cooperation with Authoritative Testing and Inspection Institutions
Centered on the District Food and Drug Inspection Institute and the Municipal Medical Device Institute, and supplemented by commercial testing and inspection agencies, we will establish a regional testing and inspection service platform for the biopharmaceutical industry. We will enhance the District Food and Drug Inspection Institute’s CMA accreditation capabilities for cosmetics testing, expand the scope of registered testing services, and collaborate with the Municipal Medical Device Institute to provide pre-testing guidance—such as technical parameter specifications for design finalization—for medical devices within the district, thereby shortening product testing cycles;Using the District Food and Drug Inspection Institute as a technical platform, establish an evaluation system for the testing, validation, and application of domestically produced laboratory analytical instruments within the jurisdiction. This will drive technological innovation and quality improvement in domestic laboratory analytical instruments and help them enter the fast-growing market for domestic substitution. (District Market Supervision Bureau, relevant sub-districts, towns, and industrial parks)
(7) Establish a Platform for the Training and Exchange of High-Level Talent in Biomedicine
Explore a “Songjiang-style” model for the training and exchange of biomedical talent. In collaboration with the Yangtze River Delta Medical Device Industry Promotion Association and its branches, strengthen vocational education and skills training based on the professional title evaluation system for biomedical technical personnel. Increase efforts to cultivate highly skilled talent for key manufacturing positions such as pharmaceutical testing, inspection, and quality control, and establish a regional database of high-level talent; guide enterprises, universities, research institutes, and medical institutions to cooperate in building educational and practical training bases for biomedical applied technologies.(District Market Supervision Bureau, District Human Resources and Social Security Bureau)
IV. Innovating Systems and Mechanisms to Drive Continuous Improvement in Service Efficiency
(8) Standardizing the Mechanism for Biopharmaceutical Product Registration Services
Develop local standards for the service specifications of biopharmaceutical registration guidance service stations, clearly defining requirements for service personnel, service items, service processes, and performance evaluation. By refining work standards, standardizing management practices, and emphasizing continuous improvement, the goal is to enhance service quality and efficiency. (District Market Regulation Bureau)
(9) Improve the Information Release Mechanism for the Biopharmaceutical Industry
Launch the “Songjiang District Biomedical Industry” journal and the “Songjiang Biomedical Product Registration Services” WeChat official account to regularly compile and disseminate updates on regional industrial development and support policies; address registration-related issues through Q&A sessions. Expand service access points by integrating service content dissemination into the “One-Stop Online Government Services” platform.(District Market Supervision Bureau, District Medical Insurance Bureau, District Health Commission, District Economic Commission, District Science and Technology Commission, District Human Resources and Social Security Bureau, District Government Services Office, District Civil Affairs Bureau, District Disabled Persons’ Federation)
(10) Innovating a Prudent and Inclusive Regulatory Mechanism Through the “Comprehensive Health Check” Special Campaign
Launch an annual “Comprehensive Health Check” special campaign in the market supervision sector. Moving from hazard elimination to quality improvement and credit restoration, the campaign will focus on resolving prominent issues where enterprises are prone to legal violations and safety hazards, as well as addressing urgent development bottlenecks. Improve the error-tolerance and correction mechanism for minor violations; within the bounds of the law, identify areas where enterprises can be granted leeway to correct errors, thereby safeguarding their steady and sustainable development and promoting higher-quality growth. (District Market Supervision Bureau)
Attachment: Implementation Plan for the Establishment of Guidance Service Points for Biopharmaceutical Product Registration in Songjiang District (Trial)
Attachment
Implementation Plan for the Establishment of Songjiang District Biomedical Product Registration Guidance Service Stations (Trial)
To improve the service system of the Songjiang Biomedical Product Registration Guidance Service Stations and enhance the capacity of sub-districts, towns, and industrial parks to serve the development of the biomedical industry, in accordance with the spirit of the notice issued by the Shanghai Municipal Drug Administration and the Shanghai Municipal Commission of Economy and Information Technology regarding the issuance of the “Implementation Plan (Trial) for the Construction of Shanghai Biomedical Product Registration Guidance Service Stations (Points),” and in light of Songjiang’s actual conditions, the functions of the Songjiang Biomedical Product Registration Guidance Service Stations (hereinafter referred to as “Service Stations”) will be extended to bridge the “last mile” of service delivery.and pilot the establishment of several Biopharmaceutical Registration Guidance Service Points (hereinafter referred to as “Service Points”) in sub-districts, towns, and industrial parks. The specific details are as follows:
I. Objectives
Leveraging the Workstation, we will pilot the establishment of 4–5 Service Points across the district that are professionally staffed, operate effectively, and offer replicable best practices. By clarifying the construction standards for “Service Points” and strengthening training and mentorship for their personnel, we aim to effectively support the development of the biopharmaceutical industry within the district.
II. Responsibilities
(1) Regularly survey the product registration needs of biopharmaceutical R&D and manufacturing enterprises within the district, as well as information on vacant industrial facilities, collect relevant data, and report it to the District Service Station;
(2) Proactively engage with enterprises planning to apply for registration and, under the guidance of the District Workstation, provide preliminary guidance and policy consultation;
(3) Proactively track the industrialization progress of projects that have already obtained certification, identify the enterprises’ practical issues and development challenges, and submit written reports to the local government and the District Workstation;
(4) Assist the District Workstation in conducting specialized training for local enterprises on policies, regulations, and quality management systems;
(5) Establish a database of key enterprises and conduct field visits and surveys in collaboration with the District Workstation;
(6) Complete other ad hoc or urgent tasks assigned by the District Workstation.
III. Establishment Requirements
(1) Industrial Planning. The region must possess sufficient spatial capacity to support the biopharmaceutical industry, have a certain concentration of biopharmaceutical-related industries, and the local government must explicitly designate biopharmaceuticals as a leading industry in its development plan.
(2) Personnel Requirements. At least two staff members must be assigned. Staff members must hold a college degree or higher and possess relevant experience in park management, investment promotion services, and license/permit processing.
(3) Office Facilities. The site must have office space capable of accommodating enterprise consultations and be equipped with necessary office facilities and equipment.
(4) Operating Funds. Sufficient funds must be available to cover the daily operations of the service point and staff training.
(5) Operational Mechanisms. Basic systems must be established covering personnel management, office facilities, service records, information security, and service supervision; periodic work plans must be formulated and reviewed; and efficient communication mechanisms must be established with local governments and district workstations.
IV. Certification Procedure
(1) Submission of Application. Each sub-district or town shall, based on industrial layout needs, submit a written application to the Songjiang District Market Supervision Administration or the District Workstation, attaching the “Songjiang District Biomedical Product Registration Guidance Service Workstation Accreditation Approval Form” (Appendix 1).
(2) Accreditation and Approval. The District Market Supervision Administration/District Workstation shall review the materials submitted by each applicant and conduct on-site inspections, accrediting those that meet the requirements.
(3) Official Inauguration. Units that pass the accreditation will be officially inaugurated with a plaque presented by the District Market Supervision Administration or the District Workstation.
V. Operational Support
(1) Operational Support. The local government and host industrial park applying to establish a service point shall provide support in terms of personnel, funding, and policies.
(2) Operational Support. After a service point is certified, the District Service Station is responsible for organizing policy and regulatory training for relevant staff; it shall also coordinate with relevant municipal and district departments to provide business guidance based on daily service needs and enterprise requirements.
(3) Operational Oversight. Service points shall establish supervision mechanisms such as suggestion boxes and complaint hotlines to proactively accept public oversight, and shall promptly implement improvements and adjustments based on reasonable feedback and suggestions.
(4) Performance Evaluation and Management. The District Service Station shall organize annual evaluations of the service points’ operations. Based on the evaluation results, service levels shall be classified into two categories: Excellent and Qualified, and the results shall be publicly announced.
Attachment: Songjiang District Biopharmaceutical Product Registration Guidance Service Site Certification and Approval Form
Contact Person: Liu Run Phone: 37615504
Address: Room 311, No. 69 Wencheng Road
Shanghai Songjiang District Market Supervision Administration
Songjiang Biomedical Product Registration Guidance Service Workstation
May 12, 2023
