A Comprehensive Report on the National Standard System of the Chinese Pharmaceutical Industry

December 15, 2025 - By 

Abstract

This report provides a comprehensive and in-depth analysis of the national standard system for the Chinese pharmaceutical industry as of December 2024. The standard system for the pharmaceutical industry in China is a complex and multi-layered structure, with the core objective of ensuring the safety, efficacy, and quality control of pharmaceutical products. It serves as the foundation for pharmaceutical regulation and the healthy development of the industry. This report systematically explores the legal and regulatory framework, core standards, and specific standards in major areas such as pharmaceutical production and equipment, quality control and testing methods, packaging and logistics, continuous manufacturing, biopharmaceuticals, and cell and gene therapy.

The study reveals several key characteristics of the Chinese pharmaceutical standard system: First, the standards are diverse, encompassing mandatory national standards (GB), recommended national standards (GB/T), national standardization guidance documents (GB/Z), industry standards (e.g., JB/T), and group standards (T/), as well as legally binding pharmaceutical standards such as the Chinese Pharmacopoeia and YBB series packaging material standards. Second, the management of standards involves multi-departmental collaboration, with the National Medical Products Administration (NMPA) leading pharmaceutical-related standards and the State Administration for Market Regulation (SAMR) managing general national standards. Third, the standard system is in a state of rapid development and continuous improvement, particularly in aligning with international standards (e.g., ICH, ISO), supporting emerging technologies, and promoting life-cycle quality management.

The conclusion of this report indicates that with the advancement of the “Healthy China 2030” strategy and the globalization of the Chinese pharmaceutical industry, the national standard system will continue to evolve toward greater scientific, systematic, and international standards, providing robust technical support for China’s transition from a pharmaceutical manufacturing giant to a pharmaceutical powerhouse.

Introduction

1. Background and Purpose

Pharmaceuticals are essential goods that directly impact public health and safety. Establishing and improving a scientific, rigorous, and comprehensive standard system is fundamental to ensuring pharmaceutical quality, regulating the market, and promoting industrial innovation. In recent years, with the rapid development of the Chinese pharmaceutical industry and profound changes in the global pharmaceutical landscape, the demand for pharmaceutical standards has increased significantly. From traditional chemical drugs, traditional Chinese medicines (TCMs) to cutting-edge biologics and cell therapies, and from traditional batch manufacturing to advanced continuous manufacturing, the scope, technical level, and update speed of standards have faced new challenges.

This report aims to systematically analyze and analyze the current national standards for the Chinese pharmaceutical industry as of December 2025. The report seeks to provide a comprehensive and authoritative reference for industry practitioners, regulatory personnel, researchers, and other stakeholders by presenting a panoramic view of the Chinese pharmaceutical standard system, its structure, core content, and management mechanisms, and to offer insights into its future development trends.

2. Scope and Methodology

The scope of this report covers all applicable standards for the Chinese pharmaceutical industry, focusing on national-level standards, including:

  • National Standards: Mandatory national standards (GB), recommended national standards (GB/T), and national standardization guidance documents (GB/Z).
  • Core Pharmaceutical Standards: The Chinese Pharmacopoeia, pharmaceutical registration standards, and technical guidelines issued by the National Medical Products Administration (NMPA).
  • Key Related Standards: Direct-contact pharmaceutical packaging and container standards (YBB series), pharmaceutical machinery industry standards (JB/T series), and emerging group standards (T/).

The research methodology involves the systematic integration and in-depth analysis of the provided search results. The scattered information is synthesized, refined, and connected through cross-validation and logical reasoning to construct a coherent and comprehensive knowledge framework. The report also incorporates an understanding of the development trends in the pharmaceutical industry to interpret the implications and future prospects of the standards.

3. Overview of the Chinese Pharmaceutical Standard System

The Chinese pharmaceutical standard system is a pyramid-like multi-layered structure. The apex is the highest legal authority, the Pharmaceutical Administration Law of the People’s Republic of China, which provides the legal basis for the entire system. Below it is the Good Manufacturing Practice (GMP), which serves as the fundamental guideline for pharmaceutical production.

The core of the system is the national pharmaceutical standards, with the Chinese Pharmacopoeia holding the highest legal authority. It is the fundamental law for pharmaceutical research, production, operation, use, and regulation. Surrounding the pharmaceutical lifecycle, there are numerous supporting standards. In the production phase, there are standards for pharmaceutical machinery and equipment (GB/T and JB/T). In the packaging phase, there are specific YBB series standards and related GB/T standards. In quality control, besides the methods specified in the Pharmacopoeia, there are numerous general testing method standards. In recent years, group standards (T/) have played an increasingly important role in emerging fields such as continuous manufacturing.

This complex and intricate standard network forms a solid barrier to ensure the quality of Chinese pharmaceuticals and promote industrial upgrading.

Chapter 1: Legal and Regulatory Framework of Pharmaceutical Standards

The operation of the pharmaceutical standard system in China relies on a robust legal and regulatory framework. This chapter examines the core legal and regulatory frameworks that support the national standard system of the pharmaceutical industry.

1.1 Core Legal Frameworks

1.1.1 The Pharmaceutical Administration Law of the People’s Republic of China

The latest revised Pharmaceutical Administration Law of the People’s Republic of China (2019 edition) is the fundamental law for pharmaceutical regulation in China. It provides the highest legal basis for the establishment, implementation, and supervision of pharmaceutical standards. The law explicitly states that the Chinese Pharmacopoeia and the standards issued by the National Medical Products Administration (NMPA) are the national pharmaceutical standards. The production, inspection, operation, and use of pharmaceuticals must comply with national pharmaceutical standards. The law also requires pharmaceutical manufacturers to conduct quality inspections of their products before release, and products that do not meet national standards shall not be released. The law also specifies detailed requirements for pharmaceutical packaging, labeling, and instructions, including the necessity of ensuring the packaging is suitable for pharmaceutical quality, storage, transportation, and medical use, and that the labeling and instructions are accurate, truthful, and legal, without false or misleading content.

1.1.2 Good Manufacturing Practice (GMP)

The Good Manufacturing Practice (GMP) is the fundamental guideline for pharmaceutical production. It is a comprehensive and systematic set of regulations that governs all aspects of pharmaceutical production to ensure product quality. Since its first issuance in 1988, GMP has undergone multiple revisions to adapt to industry development and international regulatory trends. The 2010 revision (effective from March 1, 2011) is a milestone in the development of GMP in China, with 14 chapters and 313 articles, significantly expanding and deepening the content compared to the 1998 version. It introduced advanced international concepts such as quality risk management, change control, deviation handling, and continuous improvement. The 2010 GMP not only imposes stricter requirements on hardware (facilities, equipment, materials) but also emphasizes software management, such as the quality management system. The GMP appendices also provide specific and stricter requirements for sterile products, bulk drugs, biologics, and TCM preparations.

1.2 Core Pharmaceutical Standards

1.2.1 The Chinese Pharmacopoeia

The Chinese Pharmacopoeia is the embodiment of national pharmaceutical standards in China, compiled and revised by the National Pharmacopoeia Commission, and holds the highest legal authority. It is the fundamental law for pharmaceutical research, production, operation, use, and regulation. The Pharmacopoeia is revised every five years to incorporate the latest scientific and technological advancements, reflect regulatory requirements, and align with international standards. The 2025 edition of the Pharmacopoeia is expected to be published in March 2025, with significant breakthroughs in variety inclusion, standard system improvement, quality control technology enhancement, and international standard alignment.

The Pharmacopoeia is divided into four parts:

  • Part 1: TCMs, TCM preparations, plant oils and extracts, and TCM preparations.
  • Part 2: Chemical drugs.
  • Part 3: Biologics.
  • Part 4: General rules and excipients.

The “General Rules” section specifies unified general rules, testing methods, and guidelines, while the “Monographs” section details the quality standards for specific pharmaceuticals, including characteristics, identification, tests (e.g., impurities, dissolution), and content determination. China currently has over 15,000 national pharmaceutical standards, most of which are included in the Pharmacopoeia.

1.3 Standard Formulation and Issuing Authorities

The management of the pharmaceutical standard system in China involves multi-departmental collaboration and coordination. Key authorities include:

  • National Medical Products Administration (NMPA): As the highest regulatory authority for pharmaceuticals, the NMPA is the “overall manager” of pharmaceutical standards. Its core responsibilities include organizing the formulation and revision of the Pharmacopoeia, approving pharmaceutical registration standards, and issuing key technical guidelines for GMP and other regulatory requirements. The National Pharmacopoeia Commission and the Center for Drug Evaluation (CDE) play core roles in the research, drafting, and technical review of standards.
  • State Administration for Market Regulation (SAMR) / National Standardization Administration (SAC): SAMR is the administrative authority for standardization under the State Council, with the SAC responsible for approving, numbering, and publishing national standards (GB, GB/T, GB/Z). While the NMPA manages pharmaceutical-specific standards, general technical, equipment, material, and method standards are managed by the SAC. The national standard information public service platform (std.samr.gov.cn) is the official channel for querying these standards.
  • Ministry of Industry and Information Technology (MIIT): In addition to national standards, industry standards are important supplements. The MIIT is responsible for formulating and issuing industry standards in fields such as machinery and chemicals. A large number of pharmaceutical equipment standards exist as industry standards (e.g., JB/T), providing guidelines for design, manufacturing, and selection.
  • Industry Associations: Industry associations, such as the China Chemical Pharmaceutical Industry Association and the China Pharmaceutical Packaging Association, play increasingly important roles in standardization. They can formulate and issue group standards (T/) to address emerging technologies and fill gaps in standardization, especially in areas like continuous manufacturing where standards are still evolving.

Chapter 2: Pharmaceutical Production and Equipment Standards

The quality of pharmaceuticals originates from design and is realized through production. Standardization of production processes and equipment is crucial for ensuring the stability and uniformity of pharmaceutical quality. This chapter details the national standards related to pharmaceutical production processes, key equipment, and production environments.

2.1 General Production Processes

2.1.1 Deep Dive into GMP

The Good Manufacturing Practice (GMP) is the fundamental guideline for pharmaceutical production. It is not just a set of standards but a comprehensive quality management philosophy and action guide. The core idea of GMP is that quality is not inspected into products but produced into them. GMP controls the five key factors—people, machines, materials, methods, and environment—that influence quality through strict control. Key requirements include:

  • Quality Management: Establish an independent quality management department responsible for quality assurance (QA) and quality control (QC), with veto power over product release and all quality-related matters.
  • Personnel: Specify qualifications, training, and health requirements for personnel involved in pharmaceutical production and quality management. Key personnel (e.g., enterprise leaders, production managers, quality managers) must have relevant expertise and experience.
  • Facilities and Equipment: Specify requirements for facility design, layout, construction, maintenance, and cleaning to prevent contamination, cross-contamination, and mix-ups. Strict requirements are imposed on cleanroom air purity, pressure differentials, and temperature/humidity.
  • Materials and Products: Specify procedures for procurement, acceptance, storage, release, and release of raw materials, packaging materials, intermediates, and finished products.
  • Validation and Verification: GMP introduces the concept of validation, requiring that facilities, equipment, processes, and testing methods be validated to ensure they consistently meet predetermined standards.
  • Documentation: Establish a comprehensive document system, including quality standards, process procedures, operating procedures, records, and reports. All operations must be documented to ensure traceability.

2.1.2 Process Validation Standards

Process validation is a key requirement of GMP, proving that a production process can consistently produce products meeting predetermined quality standards. While there is no independent GB/Z standard specifically titled “Pharmaceutical Process Validation,” the principles and requirements of process validation are deeply integrated into the GMP text and appendices, as well as technical guidelines. For example, the Guidance on Confirmation and Validation in the GMP appendices provides specific requirements for types of validation (pre-validation, concurrent validation, re-validation), study design, data analysis, and reporting. Additionally, standards like GB/T 28671-2012 Pharmaceutical Machinery (Equipment) Validation Guidelines provide valuable reference for understanding and implementing process validation, despite being primarily focused on pharmaceutical machinery.

2.2 Pharmaceutical Equipment and Machinery Standards

Pharmaceutical equipment is the foundation of pharmaceutical production, and its standardization directly affects the stability and reliability of pharmaceutical quality. The standard system for pharmaceutical equipment is composed of national standards (GB/T) and industry standards (JB/T), managed by the National Technical Committee for Standardization of Pharmaceutical Machinery and Equipment (SAC/TC 146).

2.2.1 Core National Standards

  • GB/T 15692-2024 Pharmaceutical Machinery Terminology: This is the most fundamental and important standard in the pharmaceutical machinery field. It unifies terminology and definitions for pharmaceutical machinery, providing a common language for standardization, technical documentation, academic exchange, and trade. It was revised in 2024 to reflect the latest industry developments.
  • GB/T 28258-2012 Classification and Coding of Pharmaceutical Machinery: This standard systematically classifies and codes various types of pharmaceutical machinery used in China, facilitating industry management, statistical analysis, information exchange, and e-commerce.
  • GB/Z 42540-2023 Pharmaceutical Equipment Containment Technology Guidelines: As the demand for high-activity and high-toxicity drugs (e.g., anti-cancer drugs) increases, the need for containment in production processes is growing. This guidance document, published in 2023, provides technical guidance for pharmaceutical and equipment manufacturers on the design, selection, verification, and use of containment equipment, protecting operator health and preventing environmental pollution.

2.2.2 Industry Standards (JB/T) Examples

Industry standards (JB/T) are more specific and cover various types of pharmaceutical equipment. These standards are numerous and cover various unit operations in pharmaceutical production. Examples include:

  • JB/T 20005-2017 Cohobation Machine: Specifies technical requirements, test methods, and inspection rules for cohabation machines used in TCM processing.
  • JB/T 20170-2019 Blow-Fill-Seal (BFS) Machine for Intravenous Bags/Bottles: Specifies performance indicators, safety requirements, and verification guidelines for advanced BFS technology equipment.
  • JB/T 20171-2019 Weighing and Blending Equipment: Specifies technical requirements for critical weighing and blending equipment in pharmaceutical production.
  • JB/T 20177-2019 Purified Water Preparation Equipment: Specifies design, material, performance, and verification requirements for core purified water preparation equipment in pharmaceutical water systems.

These specific industry standards, along with general national standards, form a comprehensive technical support system for pharmaceutical equipment standardization.

2.3 Production Environment Monitoring Standards

The production environment, especially cleanroom environments, is critical to preventing pharmaceutical contamination. GMP imposes mandatory requirements for monitoring the production environment, including suspended particle, floating microbial, settled microbial, and surface microbial monitoring.

While the search results did not provide a complete list of specific GB/T standards for pharmaceutical production environment monitoring, the relevant standards and requirements are primarily based on:

  • GMP Requirements: The GMP and its appendices (e.g., for sterile products) are the primary regulatory basis for environment monitoring, detailing static and dynamic standards for different cleanliness levels (A, B, C, D), monitoring frequency, and action limits.
  • Testing Method Standards: Actual monitoring operations often reference methods in the Pharmacopoeia General Rules, such as “Microbial Limits Test,” “Sterility Test,” and “Control of Biological Contamination in Controlled Environments.”
  • General Environmental Standards: In some cases, general environmental standards may be referenced, such as GB 37823-2019 Emission Standards for Atmospheric Pollutants from the Pharmaceutical Industry, which specifies emission limits for volatile organic compounds (VOCs) and specific harmful substances, orGB/T 16292-2010 Testing Methods for Suspended Particles in Pharmaceutical Cleanrooms (Areas) for cleanroom design and testing.

In summary, the pharmaceutical production environment monitoring standard system is a composite system based on GMP as the framework, with Pharmacopoeia methods as the core, and supplemented by relevant general national and industry standards.

Chapter 3: Pharmaceutical Quality Control and Testing Method Standards

Quality control (QC) is a key component of the pharmaceutical quality management system, responsible for inspecting and verifying that materials and products meet established quality standards. This chapter focuses on the core of pharmaceutical quality control— the Chinese Pharmacopoeia and standards related to excipients and emerging quality concepts.

3.1 The Chinese Pharmacopoeia and Quality Control System

The Chinese Pharmacopoeia is the “bible” of pharmaceutical quality control, providing the most authoritative technical and legal basis for pharmaceutical quality control.

3.1.1 General Requirements and Testing Methods

The General Rules section of the Pharmacopoeia (Part 4) is the technical foundation of the quality control system. It includes hundreds of general testing methods and guidelines, such as:

  • Chemical Analysis Methods: High-performance liquid chromatography (HPLC), gas chromatography (GC), ultraviolet-visible spectroscopy (UV-Vis), mass spectrometry (MS), etc., detailing principles, instrument requirements, system suitability, and operational procedures.
  • Formulation Rules: Rules for various dosage forms (e.g., tablets, capsules, injections), specifying general quality requirements such as weight variation, dissolution/release, disintegration time limits.
  • Microbiological Testing Methods: Microbial limits test, sterility test, endotoxin test, etc., critical for controlling microbial contamination and pyrogen risk.
  • Biological Assay Methods: Assay methods for antibiotics, hormones, etc.
  • Guidelines: Guidelines such as Guidelines for the Study of Impurities in Chemical Drugs, Guidelines for the Study of Genotoxic Impurities in Chemical Drugs, etc., provide scientific approaches for complex issues in drug development and quality research.

3.1.2 Monographs (Monographs)

The Monographs (Part 1, 2, 3) of the Pharmacopoeia detail the specific quality standards for individual pharmaceuticals. Each monograph is the “ID card” and “quality certificate” for a specific pharmaceutical, detailing its name, molecular formula, molecular weight, source (for TCM and biologics), characteristics, identification tests, tests (e.g., acidity, related substances, residual solvents, water loss), content determination methods, specifications, storage conditions, etc. Enterprises must conduct full-item inspections of each batch of product according to the monograph before release.

3.1.3 2025 Edition of the Chinese Pharmacopoeia

The upcoming 2025 edition of the Pharmacopoeia reflects current trends in pharmaceutical quality control. Based on published information, its main changes and developments include:

  • Standard System Improvement: Further improvement of general technical requirements, particularly for emerging therapeutic areas (e.g., cell therapy) and new technologies (e.g., continuous manufacturing).
  • Enhanced Safety Control: Stricter control of impurities, especially genotoxic impurities and elemental impurities, aligning with ICH Q3A/B/C/D guidelines.
  • Enhanced Efficacy Control: Encouraging the use of dissolution curve testing methods that better reflect in vivo processes and more scientific requirements for bioequivalence studies to ensure clinical efficacy consistency.
  • New Technology Application: Actively adopting advanced analytical and process analytical technology (PAT) to encourage more sensitive, accurate, and efficient testing methods.
  • Green Chemistry: Encouraging the use of environmentally friendly reagents and methods to reduce environmental pollution in testing, such as using less toxic solvents in residual solvent checks.

3.2 Excipient Standards

Excipients are essential components of pharmaceutical formulations, and their quality directly affects pharmaceutical safety, efficacy, and stability. The quality of excipients has historically been a weak link in Chinese pharmaceutical quality.

  • Standard Basis: The Pharmacopoeia (Part 4) is the main source of excipient standards. The 2025 edition significantly expands and refines excipient standards, increasing the number of included species and improving standard levels.
  • Standard Requirements: New standards emphasize “critical quality attributes” (CQAs) of excipients, focusing on physical properties (e.g., particle size, crystal form, flowability) and functional-related properties, not just chemical purity. Stricter control of safety-related indicators such as residual solvents, elemental impurities, and microbial limits is also strengthened.
  • General Testing Methods: While few GB/T standards are dedicated to excipient testing methods, the testing methods in the Pharmacopoeia General Rules are primarily used. Some general chemical reagent standards, such as GB/T 601 Chemical Reagents: Titration (Volumetric) Solutions for Standardization, provide foundational methodological support.

3.3 Quality by Design (QbD) and Risk Assessment

Quality by Design (QbD) is a revolutionary methodology in 21st-century pharmaceutical development. Its core idea is to apply systematic scientific research during drug development to deeply understand the product and process, identify critical quality attributes (CQAs) and critical process parameters (CPPs), and establish a design space (Design Space) to ensure product quality through effective process control.

  • Introduction of the Concept: QbD is widely accepted and actively practiced by leading pharmaceutical companies and regulatory authorities in China. It elevates quality management from post-production inspection to proactive and process control.
  • Related Guidelines: The National Medical Products Administration (NMPA) has fully adopted and implemented a series of ICH guidelines closely related to QbD:
    • ICH Q8 Drug Development: Outlines the basic concepts and implementation of QbD.
    • ICH Q9 Quality Risk Management: Provides tools and methods for quality risk assessment.
    • ICH Q10 Quality Management System: Integrates GMP, QbD, and quality risk management into a modern pharmaceutical quality management framework.
    • ICH Q11-Q14 and others: Further deepen QbD in areas such as bulk drug development, analytical method development, and continuous manufacturing.
  • Standard Status: As of 2024-2025, no specific GB/T or GB/Z standards for QbD have been published. This is because QbD is a scientific concept and methodology, not a quantifiable “standard.” It is more reflected in NMPA’s technical guidelines for drug development, production, and changes, and is encouraged to be applied in GMP implementation, particularly in process validation and continuous process confirmation.

Chapter 4: Pharmaceutical Packaging, Labeling, and Logistics Standards

Pharmaceuticals from production to patient use involve packaging, storage, and transportation. Standardization of these processes is crucial for protecting pharmaceutical quality, ensuring accurate information, and ensuring patient safety.

4.1 Pharmaceutical Packaging Materials and Containers

Direct-contact pharmaceutical packaging materials and containers (pharmaceutical packaging materials) are the “first line of defense” for pharmaceutical quality, directly affecting pharmaceutical stability and safety. The Pharmaceutical Administration Law explicitly requires that pharmaceutical packaging materials must be non-toxic, clean, and not react with pharmaceuticals to affect their quality.

4.1.1 Core Standards (YBB Series)

The YBB series standards are the core mandatory standards for direct-contact pharmaceutical packaging materials and containers, issued by the National Medical Products Administration (NMPA). These standards cover most commonly used pharmaceutical packaging materials, such as:

  • Glass: Sodium calcium glass infusion bottles, low-borosilicate glass ampoules, neutral borosilicate glass injection vials, etc., with specifications for water resistance, stress, heavy metal solubility, etc.
  • Plastics: Pharmaceutical-grade polyethylene (PE), polypropylene (PP), polyester (PET), polyvinyl chloride (PVC) hard films, etc., with specifications for physical properties, chemical compatibility, solubility, etc.
  • Rubber and Metal: Butyl rubber infusion bottle stoppers, antibiotic bottle stoppers, aluminum foil, aluminum-plastic composite caps, etc., with specifications for sealing, puncture resistance, chemical compatibility, etc.

4.1.2 Related National Standards (GB/T)

In addition to the YBB series, a series of GB/T standards support the YBB system, providing general technical and testing methods. Examples include:

  • GB/T 35594-2023 Packaging for Medicines: Paper and Paperboard: A new standard specifying quality requirements for paper and paperboard used in pharmaceutical outer packaging.
  • GB/T 45453-2025 Packaging: Tamper-Evident Characteristics of Pharmaceutical Packaging: A standard to be implemented in 2025, aiming to prevent pharmaceutical tampering through standardized design.
  • GB 12255-1990 Aluminum Foil for Pharmaceutical Use: Specifies material, thickness, and pinhole density for pharmaceutical aluminum foil.
  • **GB 2637-1990 Ampoules and GB 2639-1990 Glass Infusion Bottles: Older standards that may have been superseded by newer YBB or GB standards but form the foundation of the Chinese pharmaceutical glass container standard system.
  • **GB/T 12415-1990 Internal Stress Test Method for Pharmaceutical Glass Containers and GB/T 12416.1-1990 Water Resistance Test Method and Grading for Pharmaceutical Glass Containers: Provide standardized testing methods for pharmaceutical glass quality.

4.2 Pharmaceutical Labeling and Instructions

Pharmaceutical labels and instructions are the primary means of conveying pharmaceutical information and guiding safe and rational use. The accuracy, completeness, and readability of label and instruction content directly impact patient safety.

  • Legal and Regulatory Frameworks: The Pharmaceutical Administration Law is the highest legal basis for labeling and instruction management. Under this law, the NMPA has issued regulations such as the Regulations on the Management of Pharmaceutical Labels and Instructions (original National Food and Drug Administration Order No. 24, though the principles are still applied) and the Provisional Measures for the Management of Pharmaceutical Packaging, Labels, and Instructions to specify detailed requirements for format, content, changes, and approval processes.
  • Legal Content Requirements: The law and regulations mandate that labels and instructions must include: generic name, brand name, ingredients, specifications, manufacturer information, approval number, batch number, production date, expiration date, indications, dosage and administration, adverse reactions, contraindications, precautions, etc. Prescription and non-prescription drugs are distinguished by color, identification, and warning statements.
  • Latest Guidelines: Regulatory authorities may issue specific guidelines, such as the Guidelines for the Presentation of Chemistry, Manufacturing, and Control (CMC) Information in Drug Registration Applications and Final Instructions (2023), which provide specific guidance for enterprises on how to present CMC information in registration applications and final instructions.

4.3 Pharmaceutical Logistics Standards

Pharmaceutical quality assurance should not end at the point of production. During storage and transportation, environmental conditions such as temperature and humidity can affect pharmaceutical stability. Therefore, establishing a quality assurance system throughout the supply chain is crucial. This field is often referred to as Good Supply Practice (GSP). With the rise of e-commerce and third-party logistics, the demand for standardized pharmaceutical logistics is increasing.

  • Related National Standards: The National Standardization Administration (SAC) has issued a series of national standards related to pharmaceutical logistics, with core standards including:
    • GB/T 30335-2023 Pharmaceutical Logistics Service Specifications: This standard, revised in 2023, specifies basic requirements, operational processes, facility and equipment, information management, and quality control for pharmaceutical logistics services.
    • GB/T 42502-2023 Pharmaceutical Logistics Quality Management Audit Specifications: Also published in 2023, this standard provides standardized criteria and methods for auditing and evaluating the quality management systems of pharmaceutical logistics suppliers.

The publication and implementation of these standards mark a significant step forward in the standardization of pharmaceutical logistics in China, contributing to the quality and safety of pharmaceuticals during transportation.

Chapter 5: Emerging Technology Fields and Standard Development

Technological innovation is the core driver of the pharmaceutical industry. To adapt to and guide emerging technologies such as continuous manufacturing, biopharmaceuticals, and cell and gene therapy, China’s standard system is undergoing a profound transformation, moving from “following” to “catching up” and even “leading.”

5.1 Continuous Manufacturing (Continuous Manufacturing)

Continuous manufacturing is a revolution in the pharmaceutical industry, transforming traditional batch production into an integrated, continuous flow process, offering benefits such as improved efficiency, stable quality, reduced footprint, and lower costs.

  • Policy and Regulatory Orientation: The Chinese regulatory authorities highly value this technology. The “China Pharmaceutical Regulatory Science Action Plan” launched in 2019 has included continuous manufacturing as a key research area, aiming to explore regulatory frameworks and evaluation systems suitable for China’s context. Multiple ministries have issued joint documents encouraging and supporting the application of advanced technologies like continuous manufacturing in pharmaceutical enterprises.
  • Existing Standards and Guidelines: Due to the evolving nature of the technology, current standards are often in the form of guidelines and group standards, serving as exploratory and guiding tools.
    • Technical Guidelines: The Center for Drug Evaluation (CDE) has issued the Guidelines for the Application of Continuous Manufacturing Technology in Oral Solid Dosage Forms (Trial) (2019), providing preliminary regulatory and technical guidance for the application of continuous manufacturing technology in drug development, application, and production.
    • Group Standards (T/ Standards): Industry associations play a key role in this field.
      • T/PIAC00001—2023 Guidelines for Continuous Manufacturing of Raw Materials and Intermediates: The first group standard for raw material continuous manufacturing, issued by the China Chemical Pharmaceutical Industry Association, provides systematic guidance on process development, equipment, and control strategies.
      • T/SHQAP 001.2—2024 Guidelines for Continuous Manufacturing of Biological Products (Part 2: Therapeutic Proteins): Issued by the Shanghai Pharmaceutical Quality Association, this guideline extends the concept of continuous manufacturing to more complex biological products, effective from May 7, 2024, demonstrating forward-thinking.
  • Future Outlook: As the technology matures and application cases increase, successful experiences from these guidelines and standards are expected to be summarized and refined into recommended national standards (GB/T) and potentially mandatory standards, paving the way for the widespread application of continuous manufacturing in China.

5.2 Biopharmaceuticals (Biopharmaceuticals)

Biopharmaceuticals, particularly antibodies, recombinant proteins, and other advanced therapies, are major drivers of growth in the global pharmaceutical market. Their production processes are complex and require high-quality control.

  • Regulatory Framework: The GMP for Biologics is the fundamental regulatory framework. The NMPA continuously updates this framework to adapt to technological advancements. The 2025 edition of the Pharmacopoeia systematically improves the biologics standard system.
  • Standard Development: China is actively converting international standards into domestic standards. For example, the National Technical Committee for Standardization of Biological Processes is leading the development of National Standards for Biological Processes, adopting international standards such as ISO/TS 23565:2021 General Requirements and Considerations for Systems for the Manufacture of Therapeutic Cell Products. Additionally, key material standards are being developed, such as T/CBPIA 0011—2025 Quality Standard for Serum-Free Cell Culture Media for Biopharmaceuticals, issued by the China Biochemical Pharmaceutical Industry Association, to regulate core raw materials in upstream processes.

5.3 Cell and Gene Therapy (Cell and Gene Therapy – CGT)

CGT is the most cutting-edge and transformative technology in biomedicine, offering hope for diseases previously untreatable. However, its high individualization, complex production processes, and “living” nature pose significant challenges to traditional standardization.

  • Regulatory and Standard Status: This is a rapidly evolving field where standards are still being developed. The NMPA has issued guidelines such as the Guidelines for Research and Evaluation of Cell Therapy Products (Trial) and the Guidelines for Clinical Trial of Immune Cell Therapy Products (Trial), establishing a regulatory framework.
  • Existing National Standards: A significant milestone is the publication of GB/T 42466-2023 Management Technical Specifications for Human Pluripotent Stem Cell Banks, the first national standard in the stem cell field, providing standardized management for stem cell banks, including collection, storage, quality control, and information management, laying the foundation for the upstream resources of cell therapy.
  • International Standard Integration: Due to the global nature of CGT, China is extensively referencing and adopting international standards. The ISO Technical Committee 276 (Biotechnology) has published a series of relevant standards, such as ISO 20399:2022 Requirements for Ancillary Materials in the Manufacture of Cell Therapy Products,ISO 21973:2020 General Requirements for the Transport of Therapeutic Cells,ISO 23033:2021 General Requirements for the Testing and Characterization of Cell Therapy Products, andISO 20391 series General Guidelines and Method Validation for Cell Counting. These international standards are being introduced into China through various channels, serving as important benchmarks for the global CGT industry.
  • Future Challenges and Outlook: The standardization of CGT faces significant challenges. The future focus will be on establishing a comprehensive standard system covering the entire lifecycle, from donor screening, cell collection, genetic modification, expansion culture, formulation, cryopreservation, transportation, to clinical administration. Balancing the need for standardization with the individualization of therapy will be a core challenge for standard setters.

Chapter 6: Conclusion and Outlook

6.1 Summary of Key Conclusions

After a comprehensive analysis of the national standard system for the Chinese pharmaceutical industry, the following key conclusions are drawn:

  1. Complex and Multi-layered System: The Chinese pharmaceutical standard system is a complex and multi-layered structure, with the Pharmaceutical Administration Law, GMP, and the Pharmacopoeia forming the core “iron triangle” of the system.
  2. Multi-departmental Coordination: The NMPA and SAMR/SAC are the core managing authorities, with other departments and industry associations playing important roles in collaborative standardization efforts.
  3. Wide Coverage and Dynamic Development: The standard system covers the entire lifecycle of pharmaceutical development, production, packaging, logistics, and use. The system is dynamic, continuously updated and improved, with the Pharmacopoeia undergoing regular revisions.
  4. Focus on Emerging Technologies: The system is actively adapting to emerging technologies such as continuous manufacturing, biopharmaceuticals, and cell and gene therapy, with standards evolving to support innovation.
  5. Challenges in Standardization: Balancing standardization with the need for individualization in advanced therapies like cell and gene therapy remains a key challenge.

6.2 Future Outlook

The future of the Chinese pharmaceutical standard system will likely involve:

  1. International Alignment: Greater alignment with international standards (e.g., ICH, ISO) to facilitate global pharmaceutical development and trade.
  2. Scientific-Driven Regulation: Increased emphasis on science-based regulatory approaches, such as Quality by Design (QbD) and risk-based approaches.
  3. Focus on Emerging Technologies: Continued development of standards for cutting-edge technologies like continuous manufacturing, biologics, and advanced therapies.
  4. Lifecycling Standardization: Expansion of standards to cover the full lifecycle of pharmaceuticals, from research and development to post-market surveillance.
  5. Digitalization and Automation: Integration of digital tools and automation in standardization and regulatory processes.

In conclusion, the Chinese pharmaceutical standard system is evolving to meet the demands of a rapidly advancing industry, with a focus on safety, quality, and innovation. The continued development of robust and adaptable standards will be crucial for the growth and global competitiveness of China’s pharmaceutical industry.

Leave a Reply

Your email address will not be published. Required fields are marked *