The eight-year agreement: the standards‑setting and product‑analysis symposium has arrived as scheduled.

　　To further implement and carry out the “ Pesticide Regulations on Administration,” and the smooth implementation of “ Pesticide Good Clinical Practice for Registration Trials Pesticide Requirements for Registration Information》《 Pesticide The “Guideline for Validation of Product Quality Analysis Methods” and other supporting regulations were also discussed. The eighth seminar on standard development and product analysis was successfully held from August 16 to 18, 2018, at the Jinshi International Hotel in Cangzhou, Hebei Province. This session of the seminar was organized by China… Pesticide Hosted by the Industrial Association, co-organized by Hebei Zhongtian Bangzheng Biotechnology Co., Ltd., and sponsored by Cangzhou Hongyuan Agrochemical Co., Ltd. and Zhuhai Omec Instrument Co., Ltd. Ministry of Agriculture and Rural Affairs Pesticide Yang Jun, Director of the Drug Efficacy Review Division of the Inspection Institute; Wu Jinlong, Deputy Director of the Quality Review Division; and Dr. Zhou Yanming of the Environmental Review Division, Hebei Province. Pesticide Zhao Yuqiang, Director of the Inspection Institute, Cui Shouxiang, Section Chief, and Chen Yusheng, Director of the Cangzhou Municipal Bureau of Agriculture and Animal Husbandry, among others, attended the meeting. The meeting also invited representatives from the Ministry of Agriculture and Rural Affairs. Pesticide Leaders from metrology institutes, experts from research institutions and universities, and executives from leading enterprises presented 12 engaging keynote reports, drawing more than 300 participants—including corporate intellectual property managers, registration officers, and analytical technicians—from across the country.

　　Hebei Province Pesticide Director Zhao Yuqiang of the Testing Institute delivered a welcoming address, stating: Hebei is a major agricultural province, a leading producer of grain and “vegetable basket” commodities in China, and also… Pesticide Major provinces in production, use, and export; the entire province has a total of Pesticide There are 183 manufacturing enterprises, Pesticide The number of registered products stands at 2,314, both ranking third nationwide. Annually… Pesticide Production volume (expressed as 100% active ingredient) is approximately 40,000 tons, ranking sixth nationwide, annually. Pesticide The volume of goods used is approximately 40,000 tons, ranking 12th nationwide; in the first half of this year… Pesticide Export volume: 44,000 tons.

　　Director Zhao said the new… Pesticide Following the implementation of the Administrative Regulations and their accompanying rules and regulations, Hebei Province has steadily advanced tasks such as preliminary registration review, production licensing, and business licensing, and has already issued… Pesticide 44 production licenses, Pesticide More than 300 operating licenses. Agricultural production cannot do without… Pesticide , the Chinese people must firmly hold their own rice bowls, and this is even more inseparable from Pesticide . Director Zhao stated that Hebei Province Pesticide The administrative authorities will govern in accordance with the law, standardize procedures, and make every effort to boost Hebei. Pesticide The industry is developing in a healthy and orderly manner.

　　Ministry of Agriculture and Rural Affairs Pesticide Deputy Director Wu Jinlong of the Quality Review Division of the Verification Institute shared with everyone… Pesticide An insightful report outlining and interpreting the requirements for registration documentation. Deputy Director Wu will… Pesticide It defines the “Four‑Good Youth” as those who are well‑grounded, make meaningful contributions, take calculated risks, and spark constructive debate, and provides an overview of the new… Pesticide In accordance with the provisions of the “Requirements for Registration Data” and the requirements set forth in the annexes, this document compares the changes between the new and old versions of the “Data Requirements” in terms of structure and content, while also providing an overview of chemical matters. Pesticide , microorganisms Pesticide , plant-derived Pesticide Wait Pesticide Major changes to the requirements for category registration documentation.

　　Deputy Director Wu provided an overview of the certification process for testing institutions, which was officially accepted on March 1, 2018. Pesticide As of the end of July, a total of 76 entities and 124 trial scopes have been accepted for registration and approval. Pesticide A total of 26 entities have applied for recognition as registered testing units. Common issues encountered during the registration process include: ① significant deficiencies in organizational structure and quality assurance systems; ② personnel, facilities, and equipment failing to meet the requirements of the tests; ③ missing or impractical standard operating procedures (SOPs); and ④ non‑compliant typical test reports, raw data, and record‑keeping practices.

　　Ministry of Agriculture and Rural Affairs Pesticide Director Yang Jun of the Drug Efficacy Review Division at the Testing Institute primarily engaged in discussions with everyone. Pesticide Registration requirements, documentation requirements, and review criteria for efficacy testing institutions, as well as Pesticide Common issues in the review of registered efficacy data. Director Yang explained that, Pesticide The assessment requirements for the scope of registered efficacy studies primarily include: ① the testing institution and its organizational structure; ② standard operating procedures (SOPs); ③ testing facilities and laboratory premises; ④ instruments, equipment, test systems, and samples; ⑤ study protocols and implementation; ⑥ records and documentation; and ⑦ quality assurance. Pesticide The main contents of the registration-based efficacy evaluation include: benefit analysis, resistance risk and assessment data, a comprehensive evaluation report, other relevant materials, and efficacy trial data.

　　Director Yang pointed out that common issues in the review of efficacy‑testing data primarily arise in areas such as mixed formulations, laboratory bioassays, and field efficacy trials, and she provided detailed explanations addressing these frequently encountered problems.

　　2017《 Pesticide The second amendment to the Administrative Regulations and the… Pesticide The third revision of the “Requirements for Registration Data” has added chronic and subchronic environmental toxicity tests as well as advanced-stage test methods, and introduced the concepts of risk assessment and tiered management. Ministry of Agriculture and Rural Affairs. Pesticide Dr. Zhou Yanming of the Environmental Review Division at the Testing Institute first reviewed… Pesticide The evolution of environmental risk management, together with an analysis based on the revised approach to environmental data requirements, was examined. Technical grade material Major changes in the requirements for formulation registration dossiers. Dr. Zhou provided a detailed overview of the specific data requirements for environmental fate studies and ecotoxicological tests, and discussed biochemistry. Pesticide Active ingredient, microorganism Pesticide Active ingredient/formulation, plant-derived Pesticide Active ingredient/preparation, for sanitary use Pesticide Formulation, Rodenticide Wait Pesticide Requirements for dosage form documentation.

　　Dr. Zhou also drew on his own experience in reviewing and registering documentation to share with the attendees information on exemptions from environmental reporting requirements, the basic requirements for environmental risk assessment reports, and… Pesticide Precautions during the registration process.

　　Bioassay research is new. Pesticide The development of innovative eye‑tracking technologies and the refinement of biometric measurement techniques have directly accelerated the emergence of new… Pesticide The process of drug discovery not only enables the identification of compounds with novel mechanisms of action but also extends the lifecycle of established drugs. Shenyang Zhonghua Pesticide Professor Lin Changfu of the Bioassay R&D Department at Chemical Research and Development Co., Ltd. provided a detailed overview of the selection and cultivation of indoor bioassay test materials. He pointed out that, Pesticide Bioassays cannot do without test materials; test materials are… Pesticide The foundation of bioassays, and also Pesticide The prerequisite for formulation development and efficacy evaluation. The selection, renewal, and cultivation of experimental materials are… Pesticide The fundamental guarantee for the continued effectiveness of bioassay studies.

　　Professor Lin discussed herbicides, respectively, Pesticide In addition to fungicide test materials, the session covered the selection and standardized cultivation of representative bioassay test materials. Special emphasis was placed on rhizome‑induced culture for hard‑to‑control weeds such as field bindweed in herbicide testing, the screening of novel target pests—including greenhouse whitefly and western flower thrips—in insecticide test materials, and, for fungicide test materials, cucumber downy mildew, among others. Corn Rust disease, Wheat Screening of conventional living targets such as powdery mildew.

　　Good products are made, not inspected; the key to a quality system lies in effective management. Drawing on his own experience, Lu Dongliang, Manager at DuPont Agrochemicals Shanghai Co., Ltd., emphasized the critical importance of a robust quality system in ensuring product quality. He noted that quality is ultimately defined by the customer. Quality management does not add costs—it reduces them by minimizing, and ideally eliminating, variations in product quality.

　　What is the PDCA cycle? Manager Lu explained that the PDCA cycle consists of four stages: P (Plan): from defining the problem to developing an action plan; D (Do): implementing the action plan; C (Check): evaluating the results; and A (Act): standardizing and further promoting the improvements. By analyzing the current situation, identifying existing quality issues, and examining the various causes, influencing factors, and key contributors to these issues, one can formulate solutions targeting the primary causes, develop an action plan, and put it into practice. Finally, by analyzing the data and assessing the outcomes, the organization confirms the standardization of the measures and establishes new operating standards, which are then disseminated and institutionalized. The cycle concludes by identifying any unresolved issues and carrying them forward to the next PDCA phase.

　　Mr. Shang Wei, General Manager of Zhejiang Deheng Testing Technology Co., Ltd., delivered an insightful presentation on common issues and their solutions in laboratory and plant‑based analytical processes. Drawing on his company’s case studies, Mr. Shang outlined the challenges faced in both laboratory and industrial settings… Pesticide Common issues and solutions in the analysis of suspension rate, thermal storage stability, sample storage, azeotropic distillation, baseline, and integration parameters.

　　Manager Shang compared the differences between national standards and international method guidelines for common quality‑control parameters in the determination of moisture by azeotropic distillation, wet sieving, persistent foaming, and pourability. She also explained that discrepancies in analytical results typically arise from factors such as technique, instrumentation, methodology, and reference materials, and proposed corresponding solutions.

　　Safety and environmental protection have always been Pesticide Laboratories, where production‑related sensitive terms are handled, are also high‑risk environments for safety incidents; thus, laboratory safety is of paramount importance to all of us. Associate Professor Yang Ling from the School of Chemistry and Molecular Engineering at Peking University presented an overview of laboratory safety management to the attendees and examined several representative case studies. By citing typical safety accidents from both China and abroad and analyzing their root causes, she sought to heighten a sense of urgency among laboratory personnel, reinforce safety awareness, and prevent future incidents. Professor Yang emphasized that life is precious and that experimental safety demands the utmost personal vigilance; above all, we must maintain a profound respect for safety at all times.

　　Associate Professor Yang disseminated knowledge on the safety of hazardous chemicals, covering their definition, classification, and the regulatory standards used for such categorization. She emphasized that laboratory safety is not only a science but also a matter of personal competence, cultivated character, and, above all, responsibility.

　　《 Pesticide Regulations and Pesticide The “Requirements for Registration Information” stipulate that… Pesticide Researcher Huang Liang of the Institute of Plant Protection, Chinese Academy of Agricultural Sciences, took the testing and verification of product quality standards and method validation as his starting point to analyze the… Pesticide An overview of the origin, objectives and significance, legal basis and principles, as well as the main content of the standard “Guideline for Validation of Product Quality Analysis Methods.”

　　Researcher Huang stated, Pesticide The key elements of analytical method validation for product quality include the active ingredients and impurities in both the technical material and the finished formulation. The justification for method validation, whether by the manufacturing enterprise or the testing laboratory, must be applicable both to the development of entirely new methods and to the implementation of standard methods. Proper application of analytical methods not only reflects the overall quality‑control capabilities of the laboratory but also serves as evidence of the technical competence of the analysts.

　　Fang Lue Tao, Manager at Shanghai Weipu Chemical Technology Service Co., Ltd., presented on the application of analytical techniques in the comprehensive analysis of additives and formulations, as well as in formulation quality control. He primarily compared analytical methods for the surfactants K12 and AES and for functional additives, and shared case studies illustrating full‑profile analytical approaches for WG, EC, and SC formulation types.

　　Director Fang concluded that analytical techniques can address the following issues: ① analysis of active‑ingredient composition in formulations; ② identification of excipients and solvents in domestic and international formulations, along with grade recommendations; ③ compositional analysis and grade selection for compound formulations; ④ structural elucidation of individual excipients; ⑤ formulation development; ⑥ determination of active‑ingredient content, structural characterization, polymorph analysis, impurity profiling, and related assays; ⑦ standalone testing using large‑scale instruments and method development.

　　 Pesticide The industry exists. Pesticide Large production volume, Pesticide Regarding the common issues of high usage volume but low utilization rates, Consultant Xu Yan of Hebei Zhongtian Bangzheng Biotechnology Co., Ltd. stated, Pesticide Formulation optimization and quality enhancement are Pesticide The industry’s way forward lies in formulation innovation, and controlled-release technology epitomizes modernity. Pesticide The development trends of formulations. Consultant Xu presented to the attendees the latest technological advances in microcapsule suspensions, along with their internal control specifications and analytical methods, and explained how the challenges encountered during their preparation have been addressed. She concluded that microcapsule suspensions comply with national… Pesticide The “Zero Growth” initiative is poised to become mainstream in its industrial development. Pesticide One of the dosage forms.

　　According to the… Pesticide Regulations on Management》《 Pesticide In accordance with the relevant provisions of the Measures for the Administration of Registration Trials, Pesticide The “Good Laboratory Practice Quality Management Specification” has been in effect since October 10, 2017; it serves as the management standard for GLP laboratories. Director Xie Peijin of the Chemical Products Testing Center at the Zhejiang Provincial Institute of Chemical Research presented an overview of the key elements of the GLP laboratory system, along with case studies. Director Xie outlined the responsibilities of the test facility manager and quality assurance personnel within the GLP laboratory system, as well as… Pesticide Requirements for test facilities under the “Good Clinical Practice for Registration Trials.”

　　Director Xie also provided a detailed overview of the Standard Operating Procedures (SOPs). SOPs are comprehensive, guidance‑based documents that outline routine laboratory operations; they should encompass all laboratory activities and include a thorough “5W1H” description—namely, who performs the task, what is being done, when it is performed, where it is carried out, and how it is executed.

　　This conference is hosted by China. Pesticide Vice Secretary-General Fan Dongsheng of the Industrial Association, Researcher Huang Liang of the Institute of Plant Protection, Chinese Academy of Agricultural Sciences, General Manager Shang Wei of Zhejiang Deheng Testing Technology Co., Ltd., China… Pesticide The project was chaired by Li Hui, Project Manager at the Industrial Association.