Industry News

Industry News

Stay updated with the latest industry trends and market opportunities

China Policy

The Reform of China's Pesticide Administration Regulations and Industry Development Trends in 2025

2025 marks a crucial year for the iterative upgrading of China's pesticide administration regulatory system. In the middle of the year, the Ministry of Agriculture and Rural Affairs successively revised four core regulations, including the Measures for the Administration of Pesticide Registration, the Measures for the Administration of Pesticide Production Licenses, the Measures for the Administration of Pesticide Operation Licenses, and the Measures for the Administration of Pesticide Labels and Instructions. This revision is not a simple adjustment of clauses but a systematic reshaping of the industry ecology from the perspective of the entire industrial chain. This report aims to analyze the core points of this round of regulatory reforms, the structural adjustment direction of export registration, and propose practical strategies to solve key registration problems and AI-enabled paths, providing references for enterprises to adapt to the new normal of the industry. The research covers the entire-process regulations of pesticide registration, production, operation, and label management as well as the adjustment of export registration policies. It adopts the literature research method to sort out the changes in regulatory provisions, analyzes the impact of policy implementation combined with industry practices, and verifies the feasibility of strategies through cases.

The 2025 revision of pesticide administration regulations has established a full-chain supervision system, with core reforms reflected in five dimensions. In terms of registration management, the new regulations improve quality through dual measures of clarifying responsibility subjects and optimizing procedures: applicants are required to designate special personnel to be responsible for registration work and clarify the authorization of agents to strengthen responsibility traceability; innovative clauses such as "minor defects can be corrected", "other correction opportunities" and "previous data can be used for re-application" are added to balance standardization and efficiency. A pesticide enterprise shortened the registration cycle of a new preparation by 30% by virtue of these provisions. Data authenticity has become an inviolable "high-voltage line". Regulatory authorities can organize verification tests on questionable test data. Those who submit false materials will face the strictest penalty of not accepting applications from the applicant and its agent within three years. This has forced enterprises to establish a full-process data verification mechanism. A biological pesticide enterprise reconstructed its test data management system and incorporated third-party audits to avoid compliance risks. The strengthening of post-registration supervision has promoted the transformation of industry thinking. The new regulations establish a periodic re-evaluation system for pesticide varieties that have been registered for 15 years, and the evaluation results are directly linked to the qualification for registration renewal. This has prompted enterprises to shift from the "registration-oriented thinking" to the "long-term operation thinking". Many leading enterprises have eliminated high-risk varieties while increasing investment in the R&D of green pesticides, and one enterprise has increased its market share by 15% through this approach. To address the regulatory gaps caused by the rise of e-commerce, the new regulations realize integrated online and offline supervision, requiring platforms to publicize the license information of operators and clarify the penalty standards. An e-commerce platform reduced the number of non-compliant stores by 60% through automatic verification of qualifications. A full-chain responsibility traceability system has also been established simultaneously. Through measures such as prohibiting the entrusted production of technical concentrates (technical materials), standardizing entrusted processing contracts, and strictly prohibiting the leasing or lending of registration certificates, combined with the refined requirements of "one certificate, one standard" and marking the source of technical concentrates proposed in Announcement No. 925, the whole-process traceability from production to sales has been realized. A group integrated its brand resources by virtue of this system and significantly improved its brand awareness.

The administration of pesticide export registration has also undergone structural adjustments, achieving a precise balance between opening up and innovation protection. Under the original policy, the registration of new pesticides for overseas use only (EX) was monopolized by a single enterprise. After the new regulations were introduced, multiple enterprises can apply for the EX registration of the same new pesticide, which has activated market vitality. For a new fungicide developed by an innovative enterprise for the Southeast Asian market, 3 enterprises have obtained EX registration and achieved sales of 100 million yuan within half a year through differentiated channel layout. The requirements for EX registration of formulations have been significantly relaxed. For non-new pesticide formulations without similar domestic registration (PD registration), any enterprise can apply for EX registration without restrictions on content and concentration gradient. This creates conditions for enterprises to provide customized services for overseas markets. An enterprise adjusted the formulation concentration ratio according to the pest and disease characteristics of a certain African country, obtained EX registration, and achieved bulk export in the same month. While opening up, the new regulations strengthen the protection of the interests of the first developer of new pesticides. It is clearly stipulated that the EX registration of formulations within the protection period shall obtain the consent of the holder of the first domestic PD registration certificate, and the EX registration of non-first enterprises can only be renewed once. This mechanism not only protects the rights and interests of innovative enterprises but also balances market circulation efficiency. After obtaining the first PD registration certificate for a new herbicide, an enterprise shared market benefits through authorization while maintaining R&D motivation.

Facing the registration challenges under the new regulations, enterprises need to master targeted practical strategies. For the registration of new pesticides, to solve high-risk issues such as carcinogenicity and endocrine disruption, a combination of multiple technical means can be used, including in-depth research on action mechanisms, expert consultation, in vivo and in vitro tests, and QSAR (Quantitative Structure-Activity Relationship) computer model prediction. An enterprise of new insecticides shortened the registration cycle by 6 months through this method. Compiling the Feasibility Assessment and Gap Analysis Report for New Pesticide Registration in advance can effectively predict risks. The rejection reasons for the registration of non-identical technical concentrates mainly focus on the lack of impurity metabolite data, abnormal data, and inconsistency between samples and materials. The core response strategy is to establish a "technology pre-positioning + process control" system: conduct in-depth research on registration data requirements in advance, carry out synchronous data verification during the test process, and ensure the consistency between sample preparation and data declaration. An enterprise passed the registration review at one time by virtue of this strategy. The success of identical technical concentrate registration depends on three key points: first, select a control product with high matching degree through global databases, clarify key control indicators, and conduct pre-evaluation before project initiation; second, strictly control the stability of sample production processes to ensure consistency between batches; third, establish a weekly communication mechanism with testing institutions to promptly resolve data deviations. An enterprise increased its pass rate from 60% to 100% after applying this method. For formulation registration, enterprises need to consolidate the foundation of compliance. Based on the analysis of historical rejection cases, enterprises should focus on ensuring the completeness of product chemical data, the scientificity of efficacy test design, and policy adaptability. A formulation enterprise corrected 2 defects in efficacy test design through pre-registration compliance self-inspection and successfully passed the review.

Artificial intelligence (AI) has become a core engine for improving registration efficiency, with in-depth applications in multiple scenarios and broad prospects. At present, in terms of policy intelligence monitoring, AI can monitor hundreds of information websites around the world 24/7, automatically extract, summarize and push industry dynamics, ensuring that enterprises grasp regulatory changes in a timely manner. An enterprise learned about the registration policy changes of an exporting country 3 months in advance by virtue of this technology. The professional pesticide registration knowledge base robot, built based on AI, can quickly and accurately answer high-frequency technical questions based on massive internal data. This not only improves the efficiency of internal knowledge management but also frees up human resources, allowing technical experts to focus on more complex and creative work. Through AI technology, key information can be automatically extracted from original reports to generate standardized documents, which improves the efficiency and accuracy of document preparation and reduces the cumbersomeness and errors of manual operations. AI can analyze massive historical rejection opinions, summarize high-frequency problems, and provide accurate risk prediction and decision support for the review of new projects. An enterprise reduced its registration rejection rate by 40% after applying this technology. In the future, AI will move towards in-depth intelligence, realize data traceability combined with blockchain technology, and simulate the registration process through digital twins, further improving compliance efficiency.

The 2025 pesticide regulatory reform has established a new system featuring "full-chain supervision, full-cycle coverage, and global adaptation", with data authenticity, long-term compliance, and innovation protection as the core orientations. Facing this new normal, enterprises must proactively "recognize changes", scientifically "respond to changes", and courageously "seek changes" to remain invincible in the fierce market competition. Specifically, enterprises need to respond actively from three aspects: establish a normalized compliance review mechanism and integrate data authenticity into the entire R&D and production process; restructure R&D strategies to balance the requirements of domestic re-evaluation and the customized needs of overseas markets; accelerate the application of AI technology and improve registration efficiency through digital transformation. At the industry level, promoting the establishment of a compliance sharing platform and jointly building an intelligent, efficient and transparent pesticide compliance ecosystem will be an inevitable path for the high-quality development of the industry.

Tags: 中国农药 管理法规体系 发展方向 AI
Views: 94