广西壮族自治区药品检验研究院成立于1953年，是全区唯一自治区级法定药品检验机构，是广西唯一口岸药品检验机构。历经七十一载，现已发展为技术力量雄厚、专业学科较齐全、实验设施完备、业务管理规范，具备承担药品、化妆品、药品包装材料、生物制品、洁净环境、保健食品技术监督、技术仲裁检验的省级综合性检验研究机构。

现机构全称为：中华人民共和国广西口岸药品检验所、广西壮族自治区药品检验研究院、广西壮族自治区药品包装材料容器产品检测中心。

Established in 1953, Guangxi Institute for Drug Control (Alias: Port Institue for Drug Control, Guangxi, PRC; Guangxi Testing Centre for Packaging Materials for Medicinal Products and Containers) is the exclusive statutory provincial and port institution for drug inspection. Over the past 71 years, it has been developing into a technically advanced, comprehensive, well equipped and regularly managed institute of supervisory/arbitrary for drugs, cosmetics, packaging materials for medicinal products, biologics, clean environment and dietary supplements.

主要职责为：承担资质认证范围内检验检测工作。承担药品、化妆品、生物制品、药品包装材料、洁净环境等监管的技术服务工作，开展相关检验检测新技术、新方法、新标准研究、开发和成果转化工作。开展药品化妆品、保健食品质量分析研究及与安全性、有效性相关的研究工作。开展药品检验检测相关领域的交流合作。承担地方药品标准中标准物质的标定、研制工作。

Its main responsibilities include: inspection and testing within the scope of its certified capacity; technical services for regulation of drugs, cosmetics, biological products, drug packaging materials, and clean environments; research, development, and commercialization of new inspection and testing technologies, methods, and standards; research on quality analysis of drugs, cosmetics, and dietary supplements, and studies related to safety and efficacy; exchange and cooperation in relevant fields of drug inspection and testing; and calibration and development of standard substances in local drug standards.

拥有国家局中药材质量监测与评价重点实验室、广西博士后创新实践基地、广西食品药品安全检测工程技术研究中心、广西食品药品安全评价人才小高地、青蒿素及小分子化药创新联合体、中药民族药研究开发及智能制造产业化创新联合体等六大自治区级科研创新平台，以及化妆品注册与备案检验机构、香港中成药注册检验机构、我国向新加坡出口药材和中成药农残和有害金属元素检测机构等资质。辐射东盟，面向世界，检验报告在全球100多个国家、地区得到互认。目前，取得CNAS认可2160项、CMA认证1829项。

It has six autonomous region level scientific research and innovation platforms, including NMPA Key Laboratory for Quality Monitoring and Evaluation of Traditional Chinese Medicine, Chinese Material Medica, Guangxi Postdoctoral Innovation & Practice Base, Guangxi Engineering Technology Research Center for Food and Drug Safety Testing, Guangxi Highland for Food and Drug Safety Evaluation Talent, Innovation Association of Artemisinin and Small Molecule Chemical Drugs, and Innovation Association for Research, Development and Industrialized Intelligent Manufacturing of Traditional Chinese Medicine and Ethnomedicine. It also holds qualifications as an inspection organization for cosmetics registration and filing, an inspection institution for registration of proprietary Chinese medicines in Hong Kong, and a testing institution for pesticide residues and toxic metallic elements in Chinese herbal medicines and Chinese patent medicines exported to Singapore. With its focus on ASEAN and having a global reach, its inspection reports are recognized in more than 100 countries and regions worldwide. At present, the institute has passed CNAS accreditation and CMA certification for 2,160 and 1,829 items, respectively.

现有人员184人，有国家药典委员1人，二级教授2人，国家境外药品GMP检查员1人，国家GMP、GCP、CMA、CNAS专家8人，硕士生导师8人。高级职称54人，中级职称67人。博士2人，硕士87人。50名专家学者被广西人民政府和卫健委、科技厅等地方政府或部门聘为民族药审评专家、标准库专家、生物安全专家等。

Currently it has 184 staff members, including 1 member of the Chinese Pharmacopoeia Commission, 2 professors (T2), 1 GMP inspector for overseas drugs, 8 experts with national GMP, GCP, CMA, and CNAS titles, and 8 master's supervisors. 54 staff members have senior professional titles and 67 intermediate titles. There are also 2 PhD holders and 87 master's degree holders. 50 of its experts and scholars are appointed by local governments or departments as experts in the field of ethnic medicine evaluation, standards library, and biosafety, such as the People's Government of Guangxi, the Health Commission, and the Department of Science and Technology.

总建筑面积约2.7万平方米。设有屏障环境（SPF级）动物室、分子生物学实验室（P2级）、中药数字化标本馆等重要科研场地，拥有仪器设备3000多台套，总价值超2亿。全国第一梯队启用实验室信息管理系统LIMS，让检验全过程无纸化、数字化、智能化。

The institute covers a total building area of approximately 27,000 square meters. It has important research facilities such as animal rooms with barrier environment (SPF level), molecular biology laboratory (P2 level), and digital herbarium of traditional Chinese medicine. It possesses over 3,000 sets of instruments and equipment with a total value exceeding CNY 200 million. It is among the first echelon that applies the Laboratory Information Management System (LIMS) in China, making the entire testing process paperless, digitalized, and intelligent.

在“梅花K” 黄柏胶囊、铬超标胶囊、银杏叶制剂等各类安全事件，以及中国-东盟“两会”、汶川玉树大地震、新冠疫情等每一个重大事件之中，不断以专业严谨的态度，回应着时代健康的标准。

With its professional and rigorous attitude, Guangxi Institute for Drug Control has continuously kept its work in line with the standards of public health in various safety issues such as "Club K" Huangbai Jiaonang Capsules, capsules with excessive chromium, Ginkgo Leaf Preparations, as well as in major events such as CAEXPO & CABIS, the Wenchuan and Yushu earthquakes, and the COVID-19 pandemic.

积极参与国家科技支撑计划项目、国家科技重大专项课题。开展国家药品标准提高工作。荣获广西科技进步二、三等奖，中国药学会科学技术奖等荣誉。在国家药品抽检工作中，数次荣获国家局表彰。获得国家发明专利（软著）授权45项，其中11项成果实现转化。近年来，与企业联合承担省部级以上课题10余项， 与企业联合申报的6个自治区级重大项目都获得了立项，联合申报的2个联合创新体也获准批复，这些项目聚焦医药产业发展难题，助推“产学研”深度融合，成效明显。

The institute has actively participated in the projects of the National Science & Technology Pillar Program and national major science and technology special projects, and contributed its own efforts to improve national drug standards. It has obtained the second and third prizes of Guangxi Science and Technology Progress Award, as well as the Science and Technology Award from the Chinese Pharmaceutical Association, and has been commended in the nationwide unannounced drug inspection by NMPA for multiple times. In addition, it has obtained 45 national invention patents (software copyrights), 11 of which have been successfully commercialized. In recent years, the institute has jointly undertaken more than 10 provincial and ministerial-level projects with enterprises. Among them, with enterprises as joint applicants, its six autonomous region-level major projects have been approved and implemented, and two innovation associations have been approved. These projects focus on the development challenges of the pharmaceutical industry and promote the deep integration of "industry, academia and research," which have delivered significant results.

积极参与广西中药饮片炮制规范、广西壮药瑶药质量标准研究、广西中药配方颗粒质量标准研究，组织编撰了广西特色壮瑶民族药质量标准体系系列书籍12部，成果应用于整个医药产业链的环节，结束了壮瑶药“有医无药”的历史，开创民族药监管新起点。

Furthermore, the institute has actively made efforts in the standardization for the preparation of traditional Chinese medicine decoction pieces, and the research on quality standards for Zhuang & Yao ethnic medicines and TCM formula granules in Guangxi. It has organized the compilation of 12 serial books on quality standards for Guangxi's characteristic Zhuang and Yao ethnic medicines, with the achievements applied to various links in the entire pharmaceutical industry chain, which has put an end to the history of "no drug standards" for Zhuang and Yao medicines, and heralded a new starting point for the regulation over ethnic medicines.

深化中药国际交流与合作，服务东盟及“一带一路”倡议。2023年8月，“深化东南亚大宗药材质量研究合作，打造中国—东盟药品质量交流平台”获东盟常驻代表委员会（CPR）批准执行，主要针东南亚道地药材开展质量研究合作，搭建开放的国内外药材技术交流和人才培养合作平台，与东盟各国及“一带一路”沿线国家的高校或科研机构建立药材相关领域双向合作机制，促进药材质量标准的交流合作，为推动中国一东盟药材质量标准协调统一奠定基础，助力构建更为紧密的国一东盟命运共同体。加快中药高质量“走出去”，进口药材检验时限由法定的20日提升至最短2个工作日，检验效率领跑全国，免收检验费用800多万元，加速资金回笼周转约9亿元，面对疫情带来的冲击，为企业赢得了先机。同时，完成了正骨水、云香精等41个中成药出口的注册检验，为我区名优品种进入国际市场打开了通道。

With the aim of serving ASEAN countries and responding to the Belt and Road Initiative, the institute has deepened international exchange and cooperation in traditional Chinese medicine. In August 2023, the ASEAN-China Cooperation Fund project, "Deepening cooperation on quality research of Southeast Asian raw herbal materials and creating a China-ASEAN exchange platform for quality of herbal based pharmaceuticals," was approved by the Committee of Permanent Representatives (CPR) to ASEAN for implementation. The project focuses on quality research of local medicinal herbs produced in Southeast Asia, builds up an open platform of domestic and international technical exchange and talent training, and establishes a bilateral cooperation mechanism for related areas of medicinal materials with academic institutions or research institutes in ASEAN countries and those countries along the "Belt and Road." This move has promoted exchange and cooperation in quality standards of medicinal materials, laid a foundation for China-ASEAN coordination in uniform quality standards of medicinal materials, and contributed to a closer China-ASEAN community with a shared future. To boost the traditional Chinese medicine of high quality to "go global," through its efforts, the inspection time for imported medicinal materials has been shortened from the statutory 20 days to a minimum of 2 working days. Its inspection efficiency leads the country, saving inspection fees of over CNY 8 million and accelerating the turnover of approximately CNY 900 million in funds. In the face of the impact brought by the COVID-19 pandemic, it has seized opportunities for enterprises. At the same time, it has inspected 41 proprietary Chinese medicines for export, including Zhenggu Shui (bone setting liquid) and Yunxiang Jing (carminative and pain-relieving tincture), opening up channels for high-quality products from Guangxi to enter the international market.

广西药品检验研究院坚持“管理规范、检验及时、报告公正、服务优质”的质量方针，坚持科学检验、为民监管的核心价值理念，与时俱进，成为保障人民群众用药安全的坚强后盾。

By adhering to the philosophy of "standardized management, prompt testing, impartial reporting, and quality service," Guangxi Institute for Drug Control upholds the core values of scientific testing and public supervision, keeps pace with the times, and exerts itself to give strong backing to the public in ensuring the safety of medication.