Guiding Opinions of Shanghai Municipality on Modern Logistics for Pharmaceuticals

Chapter I  General Provisions

Article 1 (Purposes and Basis)

With a view to accelerating the development of modern logistics for pharmaceuticals in Shanghai, improving resource allocation, promoting the large-scale and standardized development of pharmaceutical trading enterprises, establishing an efficient and specialized modern pharmaceutical logistics system, and ensuring the supply of pharmaceuticals and their quality in circulation, these Opinions are formulated in accordance with the pharmaceuticals Administration Law of the People's Republic of China, the Vaccine Administration Law of the People's Republic of China, the Regulations of Shanghai Municipality on the Administration of pharmaceuticals and Medical Devices, the Measures for the Quality Supervision and Administration of the Trading and Use of Medicinal Products, the Good Supply Practice for Pharmaceuticals (GSP), and other relevant laws, regulations and rules, and in the light of the actual circumstances of this Municipality.

Article 2 (Scope of Application)

These Opinions apply to newly established wholesale pharmaceutical enterprises in this Municipality and wholesale pharmaceutical enterprises providing services of entrusted storage and delivery of pharmaceuticals.

Wholesale pharmaceutical enterprises already incorporated in this Municipality shall progressively upgrade their modern pharmaceutical logistics operations. Wholesale pharmaceutical enterprises which provide entrusted storage and delivery services shall comply with these Opinions regarding entrusted storage and delivery of pharmaceuticals.

Article 3 (Encouraging the Development of Modern Pharmaceutical Logistics)

Wholesale pharmaceutical enterprises are encouraged to equip themselves with facilities and equipment suitable for storage and warehousing, acceptance, transfer, shelving, sorting, outbound dispatch of pharmaceuticals as well as independent computerized logistics management systems. Such systems shall ensure whole-process quality control and information traceability, covering the entire process of business operations, including pharmaceuticals purchase, storage and delivery, and sales, thereby promoting the scaling-up, intensive, standardized, information-based, and intelligent management and operations of pharmaceutical logistics by reducing logistics operating costs and improving service capacity and standards.

Article 4 (Responsibilities for Pharmaceuticals Traceability)

Wholesale pharmaceutical enterprises and wholesale pharmaceuticals enterprises providing entrusted storage and delivery of pharmaceuticals services shall, in accordance with the general pharmaceuticals traceability standards and specifications formulated by the National Medical Products Administration, establish and implement a pharmaceuticals traceability system, see that marketing license holders fulfill their primary responsibilities for pharmaceuticals traceability, so as to ensure that the pharmaceuticals they store and deliver have verifiable sources and traceable destinations and that those responsible are held accountable.

Chapter II  Organizational Structure and Personnel

Article 5 (General Standards for Organizational Structure and Personnel)

Newly established wholesale pharmaceutical enterprises (hereinafter referred to as enterprises) shall establish a complete management system in compliance with the GSP and set up organizational divisions or employ personnel responsible for quality management, acceptance and inspection, maintenance, logistics management, and information management as well as other functions required for their business operations. The personnel in charge of quality control shall fully perform quality management responsibilities, have the power to make decision on quality of pharmaceuticals in the enterprise, and ensure that the entire process of pharmaceuticals trading always complies with statutory standards.

Article 6 (Provisions on Occupation for Key Management Personnel)

The legal representative and the principal person responsible for an enterprise shall assume overall responsibilities for its pharmaceuticals trading activities. The legal representative, the principal person responsible for the enterprise, and the personnel engaged in pharmaceuticals trading and quality management shall meet the qualification criteria set by the GSP. They shall not engage in any activity in pharmaceuticals production or trading prohibited by the Pharmaceuticals Administration Law of the People's Republic of China or the Vaccine Administration Law of the People's Republic of China.

Article 7 (Staff Criteria)

The legal representative, the principal person responsible for the enterprise, the personnel in charge of pharmaceuticals quality control, the head of the quality control department, and other personnel in the enterprise engaged in pharmaceuticals trading business management shall comply with the GSP and meet the following criteria:

1. The principal person responsible for the enterprise shall hold an associate degree or higher degree, or an intermediate level or higher professional technical title, have received basic pharmaceutical training, and have a good understanding of the relevant laws and regulations on pharmaceuticals administration as well as these Opinions.

2. The personnel in charge of pharmaceuticals quality control shall hold a bachelor's degree or higher degree, a pharmacist license, and at least three years of work experience in pharmaceuticals trading quality management, and can make sound judgment and conduct quality management.

3. The head of the quality control department shall have a pharmacist license and have at least three years of work experience in pharmaceuticals trading quality management, and shall independently resolve quality issues arising during business operations.

4. Enterprises shall provide pre-job and on-the-job training to staff in all positions concerning their duties and work. The enterprises concerned shall ensure that their staff have a good understanding of the provisions of laws, regulations and rules including the Pharmaceuticals Administration Law, and the Regulations for the Implementation of the Pharmaceuticals Administration Law, have adequate understanding of pharmaceuticals and adequate professional skills, and meet position-specific competency criteria.

5. Enterprises shall conduct pre-employment and annual health examinations for personnel in positions with direct contact with pharmaceuticals, including those engaged in quality management, pharmaceuticals acceptance and inspection, maintenance, and storage, and keep health records for such personnel.

Chapter III  Facilities and Equipment

Article 8 (General Standards for Facilities and Equipment)

Enterprises shall have business premises, storage warehouses, facilities and equipment and delivery vehicles that meet GSP standards, cover their business scope and handle the volume of their pharmaceutical logistics operations. Such enterprises shall perform validation and calibration as required, and shall have storage and delivery capabilities necessary for conducting modern pharmaceutical logistics operations.

Article 9 (Functional Warehousing Area)

The warehousing facilities of such enterprises shall handle the volume of their logistics operations and manage operational processes. Functional areas that meet pharmaceuticals quality management and logistics operation standards shall be established. The specific standards are as follows:

1. Enterprises shall have bulk storage areas and separate storage areas for small items in keeping with the volume of their pharmaceutical logistics operations. The gross floor area of a warehouse storage area shall be no less than 10,000 square meters, or its total storage volume shall be no less than 50,000 cubic meters, of which the volume of automated warehouse space shall be no less than 25,000 cubic meters. For an enterprise specializing in the delivery of biological products, the total floor area of its warehouse shall be no less than 3,000 square meters, or its total storage volume shall be no less than 10,000 cubic meters. For an enterprise specializing in delivery of vitro diagnostic reagents classified as pharmaceuticals, the floor area of its warehouse shall be no less than 60 square meters.

2. Warehouses may consist of ambient-temperature warehouses, cool warehouses, cold-storage warehouses, and warehouses with other special temperature standards based on pharmaceuticals storage needs. An enterprise engaged in cold-chain pharmaceutical logistics shall be equipped with at least two independent cold-storage units (freezers) with a total storage volume of no less than 500 cubic meters. For an enterprise specializing in the delivery of biological products, the total storage volume of its cold-storage facilities (freezers) shall be no less than 1,000 cubic meters. For an enterprise specializing in the delivery of vitro diagnostic reagents classified as pharmaceuticals which conducts cold-chain pharmaceutical operations, the volume of its cold-storage facility shall be of no less than 20 cubic meters.

3. There shall be a computer control room (area) in the enterprise, with remote control over warehouse temperature and humidity monitoring, warehouse area video surveillance, refrigerated vehicle temperature monitoring, and abnormal conditions alarm.

Article 10 (Warehousing Facilities and Equipment)

Enterprises shall be equipped with facilities and equipment that meet the operational needs of modern pharmaceutical logistics, including pharmaceuticals acceptance, inspection, conveying, shelving, sorting, outbound dispatch, checking, and order consolidation, so as to ensure smooth and continuous pharmaceutical logistics workflow and prevent risks of mix-ups and errors.

1. Acceptance and in-warehouse management equipment. Under the coordinated control of the warehouse management system (WMS), suitable equipment shall be used to conduct automatic space allocation, identification and routing as well as handling in accordance with factors such as floor area, storage modes, and distance.

2. Storage equipment. Pallets, racks, automated warehouses, or similar equipment may be installed as needed. Adequate distance shall be maintained between storage spaces and between pharmaceuticals and floors or walls. Pallets and racks shall be labeled with barcodes for space management purposes, with one code per space; they shall be controlled, managed, and dispatched by the same warehouse management system.

3. In-warehouse items handling equipment. Facilities and equipment that can handle logistics volume shall be installed for areas such as the storage area, picking area, outbound checking area, order consolidation and delivery area so as to ensure accurate and continuous logistics operations and prevent risks of mix-ups and errors.

4. Information identification and management equipment. Equipment such as barcode printing and scanning devices, radio frequency technology (RF), and electronic pick-to-light order-picking systems shall be installed.

5. Temperature and humidity monitoring equipment. Equipment for regulating warehouse temperature and humidity and facilitating indoor-outdoor air exchange, including central air-conditioning system that meets relevant environmental parameters, shall be installed.

6. Power supply equipment. Dual-circuit power supply system, backup power generator, or similar equipment shall be installed. The power rating of backup power generators shall at least be sufficient to ensure lighting in pharmaceuticals storage areas and normal operation of cold-storage equipment, temperature and humidity monitoring equipment, the computer control room (area), and server data center.

Article 11 (Delivery Vehicles)

Enterprises shall use enclosed pharmaceuticals delivery vehicles that are suitable for pharmaceuticals storage conditions and meet the needs of delivery. Cold-chain pharmaceuticals delivering enterprises shall have their own refrigerated vehicles, and such vehicles shall meet the following standards:

1. The refrigerated vehicles and onboard refrigeration equipment (including refrigerated containers and insulated containers) of these enterprises shall meet quality management standards for pharmaceuticals delivery and can handle the volume of such deliveries.

2. The technical performance of refrigerated vehicles and onboard refrigeration equipment shall meet GSP standards.

3. The refrigerated vehicles shall be equipped with independent refrigeration (heating) power supplies; they shall be connected to a satellite positioning system; they shall have onboard automatic temperature and humidity monitoring devices and remote data transmission systems to ensure real-time monitoring of movement of delivering vehicles.

Chapter IV  Information Management System

Article 12 (General Standards for Information Management)

Enterprises shall have independent information management systems. The database software, cybersecurity and application security management software, operating system software, and other related systems shall be able to handle the volume of the enterprise's pharmaceutical logistics operations, meet the relevant GSP standards, and satisfy the needs of modern pharmaceutical logistics operations, pharmaceuticals quality management, and information security.

Article 13 (Specific Standards for Information Management System)

The information management systems of enterprises shall include an enterprise resource planning system (ERP), a warehouse management system (WMS), an equipment Control System (ECS), a delivery management system (TMS), an automatic temperature and humidity monitoring system, and a pharmaceuticals traceability system. The enterprise shall maintain real-time data connectivity, exchange, and traceability among these systems with information technologies. The following standards shall be met:

1. The ERP system shall cover the entire process of pharmaceuticals trading and logistics quality management.

2. The WMS system shall maintain real-time and accurate data interfacing with the ERP, ECS, TMS, and other relevant systems, so as to ensure quality management and control throughout the entire warehousing and logistics process, including pharmaceuticals acceptance and warehouse storage, maintenance, inventory counting, outbound dispatch, returns and delivery, as well as full-process cargo inquiry and tracking.

3. The ECS system shall maintain automated and continuous logistics handling at each stage of warehouse operations, and the facilities and equipment under its control shall maintain real-time data connectivity with the WMS system.

4. The TMS system shall track, record, and control the entire process of pharmaceuticals delivery.

5. The automatic temperature and humidity monitoring system shall perform real-time monitoring and recording of warehouse temperature and humidity as well as the temperatures of refrigerated and frozen pharmaceuticals under delivery.

6. The pharmaceuticals traceability system shall trace and verify pharmaceuticals packaging units at all levels.

7. Authenticity, accuracy, completeness, security, and traceability in data entry, collection, exchange, modification and storage shall be ensured for information management systems of all types.

Article 14 (Computer Hardware and Network Environment)

Enterprises shall have a computer hardware system and network environment that can handle the volume of their pharmaceutical logistics operations; they shall meet the following standards:

1. The computer information system of such enterprises shall ensure continuous system operation and data integrity and effectively avoid service interruptions and data incompleteness caused by a single-server system anomaly, thus maintaining continued services.

2. The computer management system of these enterprises shall have fixed Internet access arrangements and reliable information security platforms; the enterprises' network gateway bandwidth shall handle their business volume.

3. Data shall be backed up on a daily basis, and stored, traced, and managed in a secure and reliable way (including off-site server, multi-machine hot backup, or cloud storage). Data records shall be kept for at least five years and for no less than one year after the expiry date of the relevant pharmaceuticals.

Chapter V  Systems and Management

Article 15 (Management Systems)

Enterprises shall establish and maintain documented management systems that meet business management standards and ensure quality of pharmaceuticals. Such systems shall include the management systems set by the GSP system as well as the following:

1. post responsibilities for pharmaceutical quality of logistics and information management departments or related personnel;

2. a pharmaceutical logistics and delivery management system; and

3. standard operating procedures and a maintenance management system for facilities and equipment.

Article 16 (Quality Management Records)

Enterprises shall keep pharmaceuticals quality management records as required, including records on pharmaceuticals acceptance and inspection, returned pharmaceuticals, warehouse temperature and humidity, pharmaceuticals maintenance and inspection, delivery check and delivery, inspection of pharmaceuticals returned from sales, control and destruction of substandard pharmaceuticals, and handling of pharmaceuticals with potential quality and safety risks. Quality management records shall be kept for no less than five years and for no less than one year after the expiry date of pharmaceuticals concerned.

Article 17 (Destruction of Pharmaceuticals)

Destruction of pharmaceuticals shall be carried out by enterprises themselves under their own supervision or under the supervision of competent regulatory authorities in accordance with applicable laws and regulations. Pharmaceuticals shall be destroyed in a harmless way that meets the environmental protection standard; the entire destruction process and each key step shall be documented.

Chapter VI  Standards for Entrusted Pharmaceuticals Storage and Delivery

Article 18 (General Standards for Entrusted Storage and Delivery of Pharmaceuticals)

Wholesale pharmaceutical enterprises engaged in entrusted storage and delivery of pharmaceuticals shall provide such service in accordance with the GSP standards, cooperate with entrusting parties in conducting quality assessment, perform their obligations under the entrustment agreement, and bear corresponding legal and contractual responsibilities. In addition to the above provisions of these Opinions, wholesale pharmaceuticals enterprises engaged in the entrusted storage and delivery of pharmaceuticals shall also comply with the standards specified in Chapter VI of these Opinions.

Article 19 (Warehousing Facilities)

Wholesale pharmaceutical enterprises engaged in entrusted storage and delivery of pharmaceuticals shall have a storage area of no less than 15,000 square meters or a storage volume of no less than 75,000 cubic meters.

Article 20 (Delivery Vehicles)

Wholesale pharmaceutical enterprises engaged in entrusted storage and delivery of pharmaceuticals shall have no fewer than eight self-owned enclosed delivery vehicles that can handle the volume of their pharmaceuticals delivery. Enterprises engaged in cold-chain pharmaceutical logistics services shall also have no fewer than three refrigerated vehicles that comply with the standards set under Article 11 of these Opinions.

Article 21 (Information Exchange for Entrusted Storage and Delivery)

Wholesale pharmaceutical enterprises engaged in entrusted storage and delivery of pharmaceuticals shall establish an electronic data interchange platform to support information exchange relating to logistics operational data and entrusted storage and delivery activities. The platform shall be capable of implementing instructions from the entrusting party relating to pharmaceuticals acceptance, inspection, warehousing, storage, maintenance, outbound dispatch, delivery, and returns; it shall conduct quality management and control throughout the entire entrusted storage and delivery process and conduct full-process tracking and tracing to ensure effective traceability of information on pharmaceuticals.

When wholesale pharmaceutical enterprises engaged in entrusted storage and delivery of pharmaceuticals have new entrusted business, conduct annual internal quality audit, or have major changes in their platform functions, they shall conduct functional operation test, validation, and verification of the information interchange platform to ensure that the platform can continuously enable exchange of relevant information between the entrusting and entrusted parties.

Article 22 (Quality Management Systems and Records)

Wholesale pharmaceutical wholesale enterprises engaged in entrusted storage and delivery of pharmaceuticals shall establish a management system for entrusted pharmaceuticals storage and delivery as well as a management system for instructions and information exchange with the entrusting party and for auditing of the entrusting party. The quality management records shall include records of pharmaceuticals acceptance instructions and dispatch instructions issued by the entrusting party.

Article 23 (Entrustment Agreement)

Wholesale pharmaceutical enterprises engaged in entrusted storage and delivery of pharmaceuticals shall enter into an entrustment agreement with the entrusting parties with express terms on matters including the scope of entrusted services, records and data management, document management, quality responsibilities, liability for breach of contract, reporting of significant issues, and assessment standards.

Chapter VII  Multi-Warehouse Coordination

Article 24 (General Standards for Multi-Warehouse Coordination)

Where several wholesale enterprises operate under a unified quality management system, they may, in accordance with relevant provisions, designate a principal party and use information technologies to share personnel, information, warehousing, delivery, and other resources with other wholesale enterprises (hereinafter referred to as the "coordinating parties") and carry out cross-regional multi-warehouse pharmaceutical logistics (hereinafter referred to as the "multi-warehouse coordination").

Article 25 (Entrusted Storage and Delivery and Multi-Warehouse Coordination)

Where a pharmaceutical marketing license holder or a pharmaceutical trading enterprise entrusts storage and delivery of pharmaceuticals to another party, it may use the multi-warehouse coordination logistics resources of the entrusted party (the principal party) to conduct cross-regional storage of pharmaceuticals.

Article 26 (Standards for the Multi-Warehouse Coordination System)

The principal party and the coordinating parties shall establish and implement a unified documented quality management system for multi-warehouse coordination and apply a unified risk control mechanism and review standards.

Article 27 (Computer System Standards for Multi-Warehouse Coordination)

The principal party and the coordinating parties shall conduct standardized management of logistics operations with information technologies and maintain real-time interfacing, exchange, and storage of pharmaceuticals delivery data, logistics information, and quality management information, so as to ensure that multi-warehouse coordination logistics operations meet the standards of pharmaceuticals trading quality management.

Article 28 (Quality Agreement for Multi-Warehouse Coordination)

The principal party shall enter into a quality agreement with its coordinating parties, specifying

issues including division of quality control responsibilities, operational standards, mechanism for handling quality issues, and emergency response plans for multi-warehouse collaboration.

Chapter VIII  Integrated Wholesale and Retail Pharmaceutical Operations

Article 29 (General Standards)

Pharmaceutical enterprises in this Municipality with the same legal person are encouraged to integrate their internal resources and carry out integrated pharmaceutical wholesale and retail chain operations (hereinafter referred to as the "integrated wholesale-retail operations"). Enterprises engaged in integrated wholesale-retail operations shall maintain modern pharmaceutical logistics and warehouses that meet the standards of these Opinions; they shall also meet the standards for the headquarters of a pharmaceutical retail chain.

Article 30 (System Standards)

Enterprise engaged in integrated wholesale-retail operations shall establish separate quality management systems that meet the standards for wholesale pharmaceutical operations and retail chain operations. Such quality management systems and related documentation shall effectively cover quality management standards for wholesale pharmaceutical operations and the retail chain headquarters. Effective measures shall be taken to prevent pharmaceuticals mix-ups and errors and ensure quality and safety of pharmaceuticals.

Article 31 (Standards for Organizational Structure and Personnel)

Enterprises engaged in integrated wholesale-retail operations shall establish divisions or designate personnel that can meet the needs of their business activities and quality management. Pharmaceuticals shall be purchased by the department responsible for wholesale operations. The same qualified person in charge of quality may assume overall responsibility for pharmaceuticals quality control; the heads of the quality control departments respectively for wholesale operations and retail chain operations shall be responsible for quality control within their respective business areas.

Article 32 (Standards for Computer System)

Enterprises engaged in integrated wholesale-retail operations shall use a unified computer system that can meet the needs of their business operations. Based on the principle that wholesale and retail chain processes are identifiable and distinguishable, such system shall maintain synchronized sharing of master data on pharmaceuticals quality and integrated management of information on pharmaceuticals quality.

Chapter IX  Supplementary Provisions

Article 33 (Definitions)

An automated warehouse means a system that uses automated and intelligent mechanical facilities (such as high-bay racks, aisle stacker cranes, unloading robots, automatic sorting systems, intelligent robotic arms for single-item picking, automated warehousing-in and outbound conveying, and other ancillary facilities and equipment) as well as a computer management and control system to accept and dispatch items.

Wholesale-retail integrated pharmaceutical operations means business activities of a single legal person who has obtained the pharmaceutical business license for both wholesale operations and retail chain headquarters to carry out wholesale and retail chain pharmaceutical operations in accordance with applicable laws and regulations.

Article 34 (Storage and Delivery of Vaccines and Special Pharmaceuticals)

The standards for storage, delivery, and data recording of vaccines and pharmaceuticals under special regulation shall be implemented in accordance with relevant national government provisions.

Article 35 (Period of Implementation)

These Opinions shall be effective as of November 7, 2025 and remain in effect for five years until November 6, 2030. The previous Guiding Opinions on Modern Pharmaceutical Logistics in Shanghai (SMMPA [2023]No.1) shall be simultaneously repealed.