Huaren Pharmaceutical Clinvantage participated in the formulation and drafting of the "Specifications for the Supply and Management of Drugs Used in Clinical Trials of Biological Products," jointly released by the China Vaccine Industry Association and the China Standardization Association. This is a normative standard document in China for the supply and management of drugs used in clinical trials of biological products.

1. Scope

This document specifies the responsibilities of relevant parties, facility and personnel management, quality management, supply process management, blinding management, and sample retention management for the supply and management of drugs used in clinical trials of biological products.

This document is applicable to the supply and management of drugs used in clinical trials of biological products for registration purposes. It can also be referenced for the supply and management of drugs used in other clinical trials and clinical research.

2. Normative References

The following documents are indispensable to the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition (including any amendments) applies.

T/CAV 032—2025 T/CAS 1061—2025 Terminology for Clinical Research of Biological Products

3. Terms and Definitions

The terms and definitions defined in T/CAV 032—2025 T/CAS 1061—2025 and the following terms and definitions apply to this document.

3.1 Biological Products

Biological products are preparations made using biological techniques from starting materials such as microorganisms, cells, animal or human tissues and fluids, and used for the prevention, treatment, and diagnosis of human diseases. This excludes microbial metabolites (such as antibiotics, amino acids, carbohydrates, and other low-molecular-weight substances). According to their purpose of use, biological products are divided into preventive biological products, therapeutic biological products, and biological diagnostic reagents.

[Source: T/CAV 032—2025 T/CAS 1061—2025, 3.1]

3.2 Clinical Trial

Scientific research using humans (patients or healthy participants) where participants or participant populations are randomly or non-randomly assigned to one or more intervention groups to evaluate the safety, efficacy, and other health-related outcomes of interventions related to the prevention, diagnosis, treatment of disease, or improvement of health status. Clinical trials are usually divided into Phase I, II, III, and IV.

[Source: T/CAV 032—2025 T/CAS 1061—2025, 3.2]

3.3 Investigational Product

Test drugs and control drugs used in clinical trials (3.2).

Note: Control drugs refer to other research drugs, marketed drugs, or placebos used in clinical trials (3.2) for comparison with test drugs.

3.4 Adjunctive Medication

In addition to investigational products (3.3), these are medications provided by the sponsor (3.7) or research institution in clinical trials (3.2) to provide sufficient preventive, diagnostic, or therapeutic medical care for subjects. They may also be drugs that elicit a certain physiological effect according to the design of the clinical trial protocol.

3.5 Clinical Trial Supply

The entire process of providing investigational products (3.3) and adjunctive medications (3.4) for clinical trials (3.2), including procurement, receipt, acceptance, storage, packaging, labeling, distribution, retrieval, and destruction, as well as document management, data management, and blinding.

3.6 Packing Material

Materials such as medicine boxes and labels used for packaging and labeling investigational products (3.3) and adjunctive medications (3.4).

3.7 Sponsor

The organization or institution that submits a marketing authorization application to the relevant regulatory authorities.

[Source: T/CAV 032—2025 T/CAS 1061—2025, 5.2.1]

3.8 Qualified Person

Personnel responsible for evaluating whether each batch of drugs meets the requirements for registration, production (packaging and labeling), control, and release; releasing products that meet regulatory requirements and quality standards; and issuing release audit records.

3.9 Service Provider

A company commissioned by the sponsor (3.7) to provide clinical trial supply (3.5) services. These services include (but are not limited to) the import and export, procurement, receipt, acceptance, storage, packaging, labeling, delivery (distribution, retrieval), and destruction of investigational products (3.3), adjunctive medications (3.4), instruments and consumables, reagents, equipment, and other materials related to clinical trials (3.2), as well as document management, data management, blinding services, and coordination and scheduling of the above procedures.

3.10 Blinding

Procedures in clinical trial (3.2) that prevent one or more parties from knowing the treatment assignment of the subjects, including single-blind and double-blind. Single-blind refers to the procedure where the subject is unaware of the treatment assignment; double-blind refers to the procedure where the subject, researcher, monitor, or in some cases, the data analyst, is unaware of the specific treatment assignment. In clinical trial (3.2), blinding is the intentional concealment of product identity according to the requirements of the clinical trial protocol; unblinding is the disclosure of the identity of the blinded product.

3.11 Clinical trial institution

An institution that meets the corresponding conditions and conducts drug clinical trials in accordance with the requirements of the Good Clinical Practice (GCP) and relevant technical guidelines for drug clinical trials.

[Source: "Regulations on the Management of Drug Clinical Trial Institutions" (No. 101, 2019), Chapter 1, Article 2]

4 Abbreviations

GCP: Good Clinical Practice

GMP: Good Manufacturing Practice

GSP: Good Supply Practice

GLP: Good Laboratory Practice

5 Responsibilities of Relevant Parties

5.1 Sponsor

5.1.1 The sponsor is responsible for the quality of all aspects of clinical trial supply. If the sponsor entrusts a service provider to provide services for the clinical trial, it should sign a commission agreement and a quality agreement with the service provider, clearly defining the responsibilities of each party, conducting regular audits of the service provider, and providing guidance, supervision, and management of its services.

5.1.2 The sponsor should establish a risk-based quality management system and bear the primary responsibility for the quality and safety of investigational medicinal products and ancillary medicinal products.

5.1.3 The sponsor should provide the clinical trial supply service provider and the clinical trial institution with a written statement of the requirements for the transportation conditions, storage time limit, operating manual, etc., of the investigational medicinal products, and other relevant documents to ensure the quality and safety of the products.

5.1.4 The sponsor is responsible for evaluating the inter-center transfer of drugs, the reuse of returned investigational medicinal products, and the conditions for disposal.

5.2 Service Provider

5.2.1 The service provider should ensure that the medicinal products comply with relevant regulations during the clinical trial supply process, and should have a quality management system, warehouse and facilities and equipment, personnel, and computerized systems that match the service content and scale, and have cold chain transportation capabilities that can cover clinical trial institutions nationwide, ensuring the quality, safety, and accessibility of the medicinal products.

5.2.2 After receiving the written statement mentioned in 5.1.3, the service provider should confirm its feasibility to the sponsor and record any deviations and handling measures during the execution process that do not conform to the statement.

5.2.3 Regularly conduct internal audits and risk assessments of the quality management system, accept audits from the sponsor and other relevant parties, and continuously improve based on the audit results to ensure the effective operation of the system.

5.3 Clinical Trial Institution

5.3.1 The clinical trial institution should assign a qualified pharmacist, or personnel with a medical, pharmaceutical, nursing, or other professional background who have received pharmaceutical management training and have been confirmed and authorized by the clinical trial institution or the principal investigator of the clinical trial, to manage the investigational medicinal products.

5.3.2 The clinical trial institution should provide a storage location for the investigational medicinal products that meets the corresponding storage conditions.

5.3.3 The clinical trial institution or the drug management personnel of the clinical trial are responsible for the management of the quality of the investigational medicinal products during their stay at the institution, ensuring that they can be received, inspected, stored, distributed, retrieved, counted, returned, and disposed of according to regulations and trial protocol requirements, and that relevant records are kept.

5.3.4 The management records of investigational medicinal products should include the date, quantity, batch number/serial number, expiration date, drug code, signature, etc.

5.3.5 The investigator should keep records of the quantity and dosage of investigational medicinal products used by each subject.

5.3.6 The quantity of investigational medicinal products used and remaining at the clinical trial institution should be consistent with the quantity provided by the sponsor.

5.3.7 The management records of investigational medicinal products should include the handling of abnormal situations in various aspects of the management of investigational medicinal products.

5.3.8 If the investigational medicinal products need to be dissolved, dispersed, diluted, or mixed before administration to the subject, this should be clearly specified in the clinical trial application, the registration materials for the investigational medicinal products, and the clinical trial protocol or relevant documents, and there should be standard operating procedure documents that meet the requirements on site.

6 Facility and Personnel Management

6.1 Warehouse and Facilities and Equipment

6.1.1 Warehouses used for the storage, packaging, and labeling of investigational medicinal products and ancillary medicinal products in various aspects of clinical trial supply should have sufficient space, and their equipment and location should facilitate cleaning, maintenance, and proper operation.

6.1.2 According to the characteristics of the investigational medicinal products and ancillary medicinal products and the services provided, different service areas should be set up in the warehouse, including but not limited to receiving area, pending inspection area, qualified product storage area, packaging material storage area, packaging and labeling area, pending shipment area, shipment area, and non-conforming product area, and an access authorization management mechanism should be established, and unauthorized or unapproved personnel should not enter restricted areas.

6.1.3 Avoid mixing different batches of drugs, containers, labels, or finished products in the warehouse to avoid confusion and contamination; the flow of the above items in the warehouse should also avoid confusion and contamination in the warehouse.

6.1.4 The warehouse should be equipped with facilities and equipment that can effectively adjust and record storage conditions according to drug storage requirements, including but not limited to equipment for controlling temperature and humidity and indoor and outdoor air exchange, equipment for automatically monitoring and recording warehouse temperature and humidity, etc., and should be validated or calibrated as required.

6.2 Personnel Qualifications and Requirements

6.2.1 All relevant parties should have sufficient qualified personnel to perform or supervise the processes of procurement, receipt, acceptance, storage, distribution, packaging and labeling, retrieval, and destruction of investigational medicinal products and ancillary medicinal products; personnel responsible for packaging and labeling should not concurrently serve as quality management personnel.

6.2.2 Staff should receive appropriate training on relevant GXP (GMP, GSP, GLP, etc., hereinafter the same) and requirements related to investigational medicinal products, and training records should be maintained.

6.2.3 The supply of investigational medicinal products may involve multiple steps such as storage, packaging and labeling, and shipment at different locations. Each location should be approved for one or more production operations and have at least one release responsible person.

6.2.4 The release responsible person should have a bachelor's degree in pharmacy or a related major (or an intermediate professional technical title or registered pharmacist qualification), possess the necessary professional theoretical knowledge and practical experience in pharmaceutical production quality management, and have undergone training related to release.

6.2.5 The release responsible person is responsible for the release of investigational medicinal products, ensuring that each batch of released investigational medicinal products complies with relevant regulations and quality standards, and issuing release review records. In special circumstances, release review records shall be issued in accordance with relevant regulations and quality standards to protect the rights and interests of subjects and in compliance with the principles of trial design.

6.2.6 Personnel with infectious diseases, color blindness, skin diseases, skin wounds, or those who may potentially negatively impact product quality and safety are prohibited from entering the storage, packaging, and labeling areas for operation or quality inspection.

6.2.7 Personnel involved in the receipt, acceptance, storage, packaging and labeling, shipment, and counting of investigational medicinal products should wear protective clothing suitable for their operations to prevent contamination of the products or damage to personnel from broken product packaging.

To be continued......