At the beginning of the establishment of New China, the domestic experimental conditions were relatively poor, and many fields were still in a blank state. In the field of drug analysis in our country, under the leadership of a group of senior scientists including An Dengkui, Cao Chuning, Zhou Tonghui, Liang Xiaotian, and Sun Zengpei, researchers overcame numerous difficulties and actively carried out research on drug quality analysis, standard setting, structural analysis, as well as the application of some new technologies and methods in the analysis of effective components of synthetic drugs and traditional Chinese medicine, which greatly improved the level of drug analysis and testing in our country.

At that time, the main work and tasks of drug analysis and testing were carried out and completed by institutions such as the Department of Pharmacology at the Central Health Research Institute of the Ministry of Health (founded in 1958, now known as the Institute of Materia Medica, Chinese Academy of Medical Sciences), the Central Drug Inspection Institute and the Drug and Food Inspection Institute (merged into the China Institute for Drug Control in 1950, reorganized into the National Institutes for Food and Drug Control in 1998), the Shanghai Drug Inspection Bureau, and a four-tiered system of drug inspection institutes from the central to provincial, prefectural (municipal), and county levels. The institutions within the drug inspection system undertook tasks including routine drug testing, research on testing technology and methods, standard research and formulation, and inspection of imported drugs. Universities and research institutions mainly focused on drug development, conducting research on new technologies and methods in drug analysis, supporting research work and testing technical services related to drug quality control and structural elucidation^[1-2].

Universities and research institutions mainly establish new drug analysis technologies and methods by introducing foreign instruments and a small amount of self-developed equipment. Some research institutions began to use relatively simple equipment for elemental analysis in the early 1950s, and academicians such as Zhou Tonghui introduced element analysis instruments produced by the Soviet Union in the late 1950s, and then imported Italian element analyzers in the 1980s, which could operate automatically. In terms of optical instruments, a QC-type UV-visible spectrophotometer, an exhibition item from Shimadzu Corporation of Japan, was purchased in 1956, which was already quite advanced at that time in China. Subsequently, more advanced automatic plotting, double-beam spectrophotometers were also introduced. In the field of chromatography, work in the 1950s mainly focused on the application of paper chromatography and column chromatography; in the 1960s, the first 60 M nuclear magnetic resonance (NMR) spectrometer in China was introduced, and under the promotion of Academician Liang Xiaotian, NMR technology was applied to drug research, especially in the structural identification of natural products, providing technical support for domestic drug development. Starting from the 1960s, gas chromatography and thin-layer chromatography were gradually used in drug analysis, with the introduction of gas chromatographs, and in the 1970s, thin-layer chromatography scanners were imported. In the late 1970s, high-performance liquid chromatography received widespread attention internationally, and there was active procurement of instruments and vigorous development of related applied research. In the area of electrochemical analysis, scientists from the Institute of Materia Medica, Chinese Academy of Medical Sciences, imported a polarograph from East Germany in the 1950s, using it to develop analytical methods for Santonin and Securinine. In the 1960s, amperometric titration was applied to the analysis of alkaloids, and self-assembled instruments were used for coulometric titration studies, playing a role in the analysis of components of traditional Chinese medicine. In the early 1980s, ion-selective electrodes for alkaloids were developed and used for content determination in tablets.

In the drug inspection system, volumetric and spectroscopic methods have played a significant role in drug testing. The instrumentation of the drug inspection system is generally lacking, with UV spectrophotometers only available in some provincial drug inspection institutes, and they are regarded as "large precision instruments." Advanced large-scale instruments such as gas chromatographs, thin-layer chromatography scanners, and high-performance liquid chromatographs were only equipped in the central drug inspection institute and some port drug inspection institutes at that time, playing an important role in the research and improvement of drug quality standards.

After the founding of the People's Republic of China, the relevant national authorities organized medical experts to compile the Chinese Pharmacopoeia. In July 1953, the first edition of the pharmacopoeia was published, including 531 varieties, using traditional Chinese characters, and adopting the old market system for units of measurement. In 1963, the second edition of the pharmacopoeia was published, incorporating qualified traditional Chinese medicines and divided into two parts, with a total of 1,310 varieties included. This edition began to use simplified Chinese characters and adopted the metric system, with the content arranged in order of preface, general notices, main text, appendices, etc. The third edition of the pharmacopoeia was published in 1977, including a total of 1,920 varieties, marking that the compilation of the pharmacopoeia began to enter a regular track^[3].

After the reform and opening up in 1978, drug analysis and testing saw significant development, achieving remarkable results and entering a stage of international exchange, cooperation, and development.

Since the reform and opening up, the overall scale of China's pharmaceutical industry has continuously grown and expanded, becoming one of the fastest-developing industries in the national economy. The level and capability of drug research and development in China have continuously improved, evolving from imitation, a combination of imitation and innovation, to innovative R&D. Policies, regulations, and technical guidelines for drug research, production, and market sales are gradually aligning and integrating with international standards. The people's demand for medication has risen from accessibility to high quality, safety, and efficacy, elevating it to the level of a right to survival. Drug scientific regulation is carried out according to the four extremely strict requirements, and drug analysis and testing play a crucial role in this process; therefore, the organizational structure, talent pool, and analytical testing technology levels of drug analysis and testing are continuously improving, aligning with international standards and entering the ranks of advanced international levels^[3].

Since the reform and opening up, the nature of the main bodies of drug analysis and testing institutions has been continuously changing, from central government-affiliated public institutions and drug inspection institutes at all levels, gradually evolving with the demand for drug development, to GLP, GCP institutions, and third-party testing institutions, especially laboratories conducting clinical biological sample analysis, which have rapidly developed. Drug inspection institutions and their work have gradually been restored and developed. After the institutional reform in 1998, drug inspection institutions were placed under the administration of the drug supervision and management department (hereinafter referred to as the drug regulatory department), establishing a three-tier government drug inspection system at the central, provincial, and municipal levels. Drug inspection institutes at all levels are managed locally and receive guidance from higher-level business departments on professional matters. There are approximately 390 drug inspection institutes above the municipal level nationwide, serving as the primary technical support for drug monitoring, inspection, and regulation. Sixty non-clinical drug research institutions have passed GLP certification, and 625 clinical drug research institutions have obtained GCP qualification recognition. Both GLP-certified and GCP-qualified institutions set up corresponding laboratories for drug quality and non-clinical/clinical biological sample analysis, supporting non-clinical (clinical) trial research^[3]. Third-party drug analysis and testing service providers have rapidly grown and expanded, such as Covance, WuXi AppTec, and Pharmaron, whose drug analysis and testing laboratories have actively promoted the progress of drug development, particularly playing a bridging role in internationalization.

The Chinese Pharmacopoeia is the statutory technical specification that ensures public medication safety and guarantees drug quality. It serves as the legal basis followed by all parties involved in drug production, supply, use, inspection, and management. After the reform and opening up, the Pharmaceutical Administration Law clarified the legal status of drug standards. To date, ten editions of the pharmacopoeia have been promulgated and implemented in China. The fourth edition was issued in 1985, and since then, a new version has been updated every five years. The 2005 edition included qualified biological products and was divided into three parts, totaling 3,214 varieties. In the 2015 edition, appendices were listed separately, dividing the content into four parts, with a total of 5,608 varieties, which is ten times the number of the first edition of the Chinese Pharmacopoeia. The current 2020 edition includes a total of 6,400 varieties, covering a more comprehensive range of drugs, including essential medicines, medical insurance catalog varieties, and commonly used clinical drugs, making it better suited to meet the needs of clinical medication.

An analysis of the changes in drug analytical techniques in the United States Pharmacopeia and European Pharmacopoeia from 1960 to the present shows that although volumetric analysis, spectroscopic and spectrometric analysis, and chromatographic analysis have all been adopted by pharmacopeias for drug quality analysis, chromatographic analysis is the primary method for drug quality analysis, with a growing trend in the use of combined technologies such as chromatography and mass spectrometry. For the Chinese Pharmacopoeia, the development trends in the quality analysis technology of chemical drugs are consistent with those abroad. The Chinese Pharmacopoeia closely integrates with the practical needs of drug research and production in China, draws on the experience of the US and European Pharmacopoeias, maintains coordination with the International Council for Harmonisation (ICH), and its consistency with international standards is increasingly high. Methods and technologies for drug quality analysis continue to improve, with chromatographic methods, especially HPLC, being the main analytical tool; meanwhile, new methods including Raman spectroscopy, supercritical fluid chromatography (SFC), critical point chromatography, and determination methods for the forms and valences of mercury and arsenic elements have been included. Given the complexity of traditional Chinese medicine (TCM) components and the demand for efficient, high-throughput, and low-cost TCM identification tests, thin-layer chromatography (TLC) remains the preferred method for TCM identification due to its speed and simplicity. However, for the determination of TCM content, high-performance liquid chromatography (HPLC) is increasingly used, and the number of TCM fingerprint profiles established using chromatographic methods and included in the Chinese Pharmacopoeia is also on the rise.

With the rapid increase in the variety of pharmaceutical excipients and the gradual improvement of testing standards for pharmaceutical excipients and packaging materials in our country, the Chinese Pharmacopoeia has included more than 600 types of excipients, forming an independent volume. As a result, HPLC technology, which is accurate and easy to operate, has been widely applied.

In pursuit of the most stringent standards, over the years, our country has continuously improved the domestic pharmaceutical standards by accelerating the establishment of a scientific, comprehensive, verifiable, and enforceable drug standard system. Currently, the standards for chemical and biological drugs in our country have basically aligned with international standards, while the standards for traditional Chinese medicine are at the forefront globally in the field of herbal medicines.

In 1984, the Asian Olympic Council decided to hold the 11th Asian Games in Beijing, China in 1990. According to regulations, the host country must undertake the task of doping testing for athletes. In 1985, the State General Administration of Sports decided to establish its own doping testing laboratory. The doping testing laboratory in our country had to be established by 1989 and pass the qualification examination of the International Olympic Committee. In the summer of 1986, the State General Administration of Sports approached Mr. Zhou Tonghui for assistance. Professor Zhou Tonghui and all researchers in the analytical laboratory accepted this task without hesitation. An agreement was signed in September 1986, and after more than two years of effort, a systematic analysis and testing method for 100 types of banned drugs in five categories (stimulants, β-blockers, anesthetic analgesics, steroid hormones, and diuretics) as stipulated by the International Olympic Committee was established at the beginning of 1989, using gas chromatography, liquid chromatography, and gas chromatography-mass spectrometry for screening and confirmation. Since March 1989, three pre-examinations with 10 unknown urine samples each; two level tests with 4 unknown urine samples each; and the final official examination, also with 10 unknown urine samples, were conducted; all correct results were provided within 24 h, passing at once, earning praise from the examiners of the International Olympic Committee. At the end of 1989, it received the doping testing qualification certificate issued by Prince de Mérode, Chairman of the IOC Medical Commission, becoming the 20th in the world, the 3rd in Asia, and the 1st in the Third World qualified doping testing laboratory. This research achievement significantly improved our country's international standing in the field of doping testing and was therefore commended by the Ministry of Health, the State General Administration of Sports, and the Beijing Municipal Government, winning the First Prize of National Science and Technology Progress and the Special Prize of Scientific and Technological Progress of the State General Administration of Sports.

Drug analysis and testing run through all stages of drug discovery, preclinical research, clinical research, production, sales, and market application. The development of drug analysis technology has always focused on the two core issues of drug efficacy and safety, continuously innovating in more efficient, higher throughput, more accurate, and more sensitive analytical technologies, which have been fully researched and applied in the field of drug analysis^[4]. At the same time, every event related to drug efficacy and safety during the development process of drugs has promoted the rapid development of analytical testing technologies, thereby making the quality of drugs more stable and ensuring greater efficacy and safety.

The objects of pharmaceutical analysis include: raw materials, formulations, excipients, and packaging material analysis; the main testing items of pharmaceutical analysis mainly include: drug component identification (structural analysis, physicochemical property analysis), drug component analysis (impurity analysis, content determination, in vivo components and metabolite analysis), excipient and packaging material analysis (identification, content determination). From the perspective of analytical technology characteristics, it can be divided into two major categories: process analytical technology and final product analytical technology. Process analytical technology is primarily used for monitoring key process intermediates during the production of active pharmaceutical ingredients and formulations through online non-destructive analytical techniques. Commonly used analytical technologies include attenuated total reflection infrared spectroscopy (ATR-FTIR), diffuse reflectance Fourier transform infrared spectroscopy (DRIFTS), near-infrared spectroscopy (NIRS), Raman spectroscopy, solid-state nuclear magnetic resonance (NMR), terahertz (THz) spectroscopy, and other vibrational spectroscopies, differential scanning calorimetry (DSC), thermogravimetric analysis, etc. Final product analytical technologies include: volumetric analysis, spectral and wave spectral analysis, chromatographic analysis, among which chromatographic analysis methods are currently the primary technical means for drug quality analysis.

Since 2003, with the strong support of the Ministry of Finance and the State Food and Drug Administration, the National Institutes for Food and Drug Control, in conjunction with relevant drug inspection institutes, has developed a vehicle-mounted rapid drug testing system. This system initially established a rapid drug testing system composed of an on-site rapid preliminary screening platform carried by drug testing vehicles, a laboratory rapid confirmation platform based on authorized methods, and a data information management network platform for drug testing vehicles. The drug testing vehicle integrates modern information and classical chemical testing methods, combining China's independently developed near-infrared technology with computer technology. It combines the original innovation of vehicle-mounted near-infrared identification methods with the integrated innovation of other vehicle-mounted identification methods into specialized vehicles in motion, forming a rapid testing method centered on vehicle-mounted near-infrared identification technology. A new operational model was created and implemented: "supervision and inspection, information acquisition, preliminary screening and sampling, rapid identification, targeted sampling, goal-oriented testing, and administrative punishment." In the preliminary screening phase, this model demonstrates numerous technical advantages such as convenient and accurate drug identification and non-destructive to samples. It also initiated a harmonious law enforcement situation where preliminarily qualified drug samples could be returned without damage to the regulatory subjects, enhancing the targeting of drug sampling and testing. Currently, 346 drug testing vehicles have been deployed in 26 provinces (autonomous regions, municipalities), vividly demonstrating the role of drug inspection technology and generating significant social and economic benefits.

Currently, China's pharmaceutical industry is transitioning from a "major pharmaceutical country" to a "pharmaceutical power." Although the gap between China's new drug development level and that of foreign countries is narrowing, issues such as clustering of targets and concentration of indications still exist to varying degrees. Many new drug developments mainly follow the paths of "following," "modifying," and "buying," focusing on discovered, validated, and low-failure-rate areas of innovation. Drug development needs to shift from "follow-up innovation" to "original innovation," with "creating demand" gradually replacing "demand-driven" as the primary driving force for innovative drug research and development.

Innovative drug development is a systematic engineering project that involves interdisciplinary collaboration, including disease market research, molecular mechanism studies, target selection and validation, molecular design, lead compound synthesis and optimization, preliminary screening of efficacy, pharmacokinetics, and toxicity, preclinical studies, clinical trials, new drug evaluation, and marketing. Drug analysis serves as both the driving force for innovative drug development and an important link that connects and closely coordinates each stage.

The interactions between small molecules and proteins in organisms (such as target occupancy, selectivity, etc.) are key information for drug structure improvement and drug development. Currently, chemoproteomics technologies have been widely applied in drug target discovery, including the design and synthesis of bioactive molecular probes, in situ labeling of proteins with probes in complex proteomes, separation of labeled proteins from background proteins, preparation of peptide samples, mass spectrometry detection, and data analysis. Among these, designing and synthesizing corresponding molecular probes based on known molecular information (structure, SAR, phenotype, etc.) is one of the core steps in this process, which involves chemically modifying (bioorthogonalization, photocrosslinking, etc.) small molecules at appropriate sites. Such probes not only retain the ability to bind to potential target proteins but also enable the subsequent separation and enrichment of bound proteins, thereby identifying the target proteins. Activity-based protein profiling (ABPP), developed by Professor Cravatt's team at the Scripps Research Institute, is used for screening covalent small molecule lead compounds targeting "undruggable" protein targets. The application of this method has accelerated the screening of covalent drug lead compounds, enabling large-scale exploration of potential ligand binding pockets at the level of complex proteomes, and providing opportunities for targeting "undruggable" proteins.

Pharmaceutical quality risks objectively exist and cannot be ignored. In the past 20 years, China has experienced multiple drug safety incidents, including the "Qier Medicine-Leukomycin Injection" incident and the "Anhui Huayuan Clindamycin Phosphate Injection (Xinfu)" incident from a while back, and more recent events such as the "problem capsule" incident, the "valsartan" incident, and the "Changchun Changsheng vaccine" incident, all of which have caused nationwide shock. While these drug safety incidents have prompted reflections on reforms to the drug review and approval system, they also call for more technological innovations, using scientific regulation to build a technical defense line for drug safety, especially through the innovation of modern digital and automated technologies.

Pharmaceutical regulatory science is a discipline that focuses on cutting-edge issues. With the rapid development of new technologies, materials, and processes, innovative pharmaceuticals and medical devices such as nanoproducts, immunotherapies, and drug-device combinations are continuously emerging and being put into clinical use. How to regulate these new products is a significant challenge brought about by new technologies. In 2019, the National Medical Products Administration launched the China Pharmaceutical Regulatory Science Action Plan and identified the first batch of nine key research projects, including cell and gene therapy products, drug-device combination products, artificial intelligence medical devices, and safety evaluation studies of traditional Chinese medicine. This plan aims to be based on the actual work of pharmaceutical regulation in our country, focusing on the innovation and reform of the pharmaceutical review and approval system, closely following the forefront of international regulatory developments. It plans to innovate through a series of regulatory tools, standards, and methods. After 3-5 years of effort, it intends to formulate a batch of regulatory policies, review technical guidelines, inspection and evaluation techniques, and technical standards to effectively solve the prominent issues affecting and restricting pharmaceutical innovation, quality, and efficiency, and accelerate the realization of modernization in the pharmaceutical governance system and capabilities.

Pharmaceutical analysis is the primary discipline that directly reflects the quality attributes of drugs and is irreplaceable in risk monitoring and risk identification. Advanced pharmaceutical analysis technologies play a crucial role in preventing drug safety incidents, conducting full lifecycle traceability of drugs, and performing in-depth and rapid investigations into adverse drug events. With the development of biopharmaceutical sciences, especially with the increasing application of innovative algorithms, intelligent robots, high-precision sensors, and other cutting-edge digital and automated technologies in pharmaceutical analysis, representative applications include rapid testing, process analytical technology (PAT), and the accompanying electronic traceability and digital quality assurance (DQA, or "digital QA") information systems, which have also led to the rapid development of scientific drug regulation.

With the continuous development of technology, digital and automated drug analysis technologies (Automated drug analysis technology, ADAT) are playing an increasingly important role in pharmaceutical regulation, especially rapid drug testing (Rapid drug testing, RDT) which has great potential in effectively preventing or investigating drug-related incidents. RDT, with its advantages of simple operation and accurate results, provides a reliable guarantee for quickly and promptly screening out counterfeit and substandard drugs, greatly enhancing the targeted nature of drug sampling inspections. Microbial rapid detection techniques applicable to drug testing include: Gram staining, adenosine triphosphate bioluminescence technology, flow cytometry, isothermal microcalorimetry, solid-phase cell counting, loop-mediated isothermal amplification, and gene probe technology. Liquid chromatography-mass spectrometry can not only rapidly separate complex components but also analyze the structure of specific components, making it increasingly used for detecting illegal additives and adulteration in drugs; compared to traditional high-performance liquid chromatography, ultra-high performance liquid chromatography offers faster separation, higher sensitivity, better resolution, and stronger resistance to interference, and is gradually being applied to qualitative and quantitative product testing. Rapid identification methods such as near-infrared spectroscopy and Raman spectroscopy have also been developed and applied in drug analysis, enabling quick identification.

Biopharmaceuticals and high-performance medical devices are listed as one of the ten key areas of "Made in China 2025", with innovation being the core and intrinsic driving force for their future development. The significant advantages of intelligent manufacturing in biopharmaceuticals are manifested in: first, ensuring the stability of drug quality, reducing the impact of human factors in the production process, guaranteeing the continuity and standardization of production processes for innovative drugs, generic drugs, vaccines, and other varieties, as well as promoting the completeness and traceability of full life cycle records, which is conducive to advancing the supply-side structural reform in the manufacturing industry and facilitating the transformation of production methods towards customization, distribution, and service orientation; second, the assurance of high-quality drugs will inevitably enhance the international competitiveness of China's pharmaceutical exports, allowing for greater participation in the global pharmaceutical economy and striving for more discourse power; third, intelligent manufacturing in pharmaceuticals will greatly reduce the continuously rising labor costs, achieving the substitution of manual labor with intelligent system control; fourth, it significantly alleviates the constraints imposed by pharmaceutical environmental issues, realizing green production and a circular economy, thereby promoting the sustainable development of the pharmaceutical industry.

Combining measurement technology with biopharmaceutical manufacturing is the foundation for achieving digital, networked, and intelligent biopharmaceutical smart manufacturing. The development of smart manufacturing by pharmaceutical enterprises can be advanced in four steps: First, develop intelligent pharmaceutical equipment that can achieve functions such as in-machine testing, compensating for processing errors, and improving processing accuracy; Second, develop intelligent pharmaceutical production lines that have characteristics like data collection, real-time production status, online quality inspection, flexible production, small batch, and multi-variety production modes; Third, develop intelligent workshops that can perform real-time collection and analysis of production conditions, equipment status, energy consumption, production quality, and material consumption, allowing for efficient scheduling and reasonable shift arrangements, which can significantly improve equipment utilization; Fourth, develop intelligent factories where the production process achieves automation, transparency, visualization, and lean product inspection, quality inspection and analysis, and the production logistics and production process are integrated in a closed loop.

Artificial intelligence, blockchain, cloud computing, the Internet of Things, and other new era concepts are rapidly integrating into drug analysis technologies. Process analysis techniques (PAT) and digital QA, among other information-based quality systems, are continuously expanding the connotation of drug analysis in smart manufacturing. PAT designs, analyzes, and controls production processes by using online process analytical instruments to promptly measure key quality parameters and performance characteristics of raw materials, in-process materials, and the process itself. This allows for an accurate assessment of the quality status of intermediate and final products, reduces human intervention, and makes production more fluid and efficient, with higher product quality. Currently, the analytical tools studied in PAT include spectroscopic techniques, optical imaging techniques, dynamic light scattering, gas chromatography, mass spectrometry, nuclear magnetic resonance, infrared spectroscopy, ultraviolet-visible spectroscopy, and X-ray fluorescence, with sensor technology also being continuously innovated and optimized. Among these, the pharmaceutical industry has focused more on spectroscopic techniques, including near-infrared spectroscopy, Raman spectroscopy, fluorescence spectroscopy, and optical imaging techniques.

With the development of information technology, full-chain platforms are gradually demonstrating their advantages in the field of pharmaceutical laboratory risk control, capable of integrating drug analysis instruments from isolated computerized systems into a complete data carrier, achieving full-process audit trails, and traceability at all stages of the lifecycle.

With the globalization and commercialization of sports, many athletes, in order to stand out in fierce sports competitions for economic benefits and personal honors, have resorted to using performance-enhancing drugs. In medicine, performance-enhancing drugs originally referred to substances that could stimulate the human nervous system, causing excitement and thus improving functional states. Later, in the sports community, they came to generally refer to any substance that can act on the human body to help athletes improve their performance; these are also known as banned substances. The use of performance-enhancing drugs not only causes serious harm to athletes' health but also goes against the spirit of fair play and integrity in competitive sports. Therefore, countries around the world have increased their efforts to combat the use of such substances, with China issuing a series of relevant policies prohibiting their use. Doping control has always been a distinctive research area within drug analysis. In response to the need for detecting banned substances at the 11th Asian Games, Academician Zhou Tonghui was entrusted in 1987 with the task of establishing the China Anti-Doping Center, where he developed a comprehensive chromatography and mass spectrometry database, along with a full set of detection and confirmation methods for five categories of 100 types of prohibited performance-enhancing drugs unique to China. "Research and Implementation of Doping Detection Methods" was awarded the First Prize of the National Science and Technology Progress Award in 1992.

In 2007, the China Doping Control Center and other departments were reorganized into an independent government bureau-level institution—the "China Anti-Doping Agency". According to statistics, in 2020, the China Anti-Doping Agency conducted a total of 14,072 inspections, with the Beijing laboratory completing 12,225 tests. Throughout the year, 319 educational access sessions, 154 educational outreach activities, and 477 educational lectures were held. A total of 31 doping violations were investigated. By the end of 2020, 20 national sports management units had established anti-doping departments, and 27 provinces (regions, municipalities) had set up provincial anti-doping institutions. The anti-doping governance system has shown significant effectiveness, with the positive rate decreasing from 0.23% in 2019 to 0.16%.

The struggle between the use of performance-enhancing drugs and anti-doping efforts has always been intense, with drug analysis being a powerful means of detecting doping. With the development of separation techniques in analytical chemistry and the emergence of new analytical instruments, more types of performance-enhancing drugs can be detected. However, the detection of performance-enhancing drugs still faces many challenges. The concentration of banned substances in the body is very low, sometimes requiring the detection of their metabolites, while the metabolism of drugs in the human body is relatively complex and several reactions may occur simultaneously; there are individual differences among different users in the process of drug metabolism; the concentration of drugs in the body varies with the duration of drug use; some performance-enhancing drugs may be converted into other categories of performance-enhancing drugs after metabolism; for different drugs, it is necessary to choose different and appropriate separation and detection methods; at the same time, new drugs are constantly emerging, which poses new challenges to chemical analysis and detection, demanding the pursuit of more accurate, rapid, and convenient analytical methods.

Urine tests remain the primary method for doping detection, while blood tests are used as a supplementary means to deal with prohibited substances that are difficult to detect in urine samples (such as growth hormones, erythropoietin, and other protein/glycoprotein hormones, as well as exogenous red blood cells) and prohibited methods. During the 2022 Beijing Winter Olympics, a new doping test method called "dried blood spot" made its official debut. This new technology involves taking a tiny amount of peripheral blood from athletes and placing it on filter paper to test for the presence of prohibited substances, a process similar to finger-prick blood sampling in hospitals. Compared to traditional blood tests, dried blood spot technology causes minimal harm to athletes, the samples are easier to transport and store, and better maintain sample stability, offering significant advantages in convenience and cost-effectiveness, which has led to high expectations from anti-doping professionals.

Drugs refer to opium, heroin, methamphetamine, morphine, marijuana, cocaine, and other anesthetic and psychotropic substances that can cause addiction as regulated by the state. The global drug problem has posed a significant threat to human survival and development. In 2020, the United Nations Office on Drugs and Crime (UNODC) released the World Drug Report 2020, which pointed out that there are currently more than 35 million people addicted to drugs globally. The report noted that in 2018, about 269 million people worldwide used drugs, an increase of 30% from 2009. According to a report released by the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA), hard drugs have swept across the European continent, and in recent years, new trends have emerged: the purity of drugs is getting higher and higher, and the ways to obtain them are becoming easier and easier. Moreover, Belgium has replaced Spain as the transit country for cocaine entering Europe. Among Europeans aged 15-34, 17.2 million have used marijuana.

Drug abuse brings disaster to the country and its people. Carrying out anti-drug struggles and eliminating the harm of drugs is a historical responsibility of the Chinese government. At the beginning of the founding of New China, the Party and the state once faced a catastrophic situation with 300,000 drug manufacturers and dealers nationwide and nearly 20 million drug users. The Central People's Government immediately took decisive measures, launching an anti-drug movement across the country, confiscating drugs, banning opium poppy cultivation, closing opium dens, and severely punishing drug manufacturing and trafficking activities. More than 80,000 drug criminals were sentenced, and 20 million drug addicts quit their addiction, combining rural land reform to eradicate opium poppy planting. In just three years, it created the "Chinese Anti-Drug Miracle" of completely eradicating the opium that had plagued China for a hundred years. It can be said that the eradication of drugs became an important symbol of the rise of New China and the rejuvenation of the Chinese nation. In 2014, the Opinions of the CPC Central Committee and the State Council on Strengthening Anti-Drug Work clearly incorporated anti-drug work into the national security strategy and made it an important part of building a peaceful and law-based China.

How to monitor illegal drug use also falls within the scope and tasks of pharmaceutical analysis. Drug testing includes urine tests, blood tests, hair tests, sweat tests, and saliva tests. The detection time window for urine and blood tests is very short, about 7 days, which allows drug users to "quit" about 7 days before the test to evade detection, thereby increasing the difficulty of public security management. Hair trace drug testing not only solves the problem of difficult urine collection but also avoids interference from medications. Hair testing has a long validity period and can detect drug use history of up to half a year under compliant conditions, covering 12 common types of drugs (such as methamphetamine, heroin, ecstasy, ketamine, morphine, cannabis, etc.), as well as 32 kinds of toxins and their metabolites. Hair drug testing plays a significant role in monitoring and evaluating community-based drug rehabilitation, screening for hidden drug use among high-risk individuals, and employees in specific industries. In recent years, many countries have adopted wastewater-based epidemiology (WBE) technology to monitor drug issues by analyzing the chemical composition of sewage or the metabolites in human urine to trace the source of drugs. A study conducted in eight major European cities in 2016 showed that there was a strong correlation between the cocaine content detected in wastewater and the data on seized drugs, indicating that WBE can reflect drug use in communities. Additionally, WBE research can more objectively reflect the effectiveness of government anti-drug operations. Relying solely on traditional drug monitoring methods, such as counting the number of arrested drug users or the amount of drugs seized by the police, is not direct enough and can be misleading.