Strategies for China’s Pesticide Registration and Market Entry: Research and Compliance – Part 2

Feb. 02nd, 2024

Overseas pesticide companies outside of China face a crucial challenge in navigating the Chinese pesticide market. Understanding upcoming regulatory changes and conducting thorough research and evaluation of the Chinese new pesticide market is vital for success.

This article serves as part two of an informative series, where we delve into strategies related to conducting market research to understand the Chinese pesticide market, as well as ensuring compliance with regulatory requirements for successful market entry.

To access part one, please click here, where we focus on the upcoming regulatory changes that companies need to be aware of.

Three Stages of New Pesticide Registration in China

The process of registering new pesticides in China involves three key stages that are critical to the success of the project. Overseas pesticide companies outside of China need to understand and effectively navigate these stages. Here is a clear breakdown of each stage:

  1. Planning and Evaluation: This initial stage includes product market analysis, product selection, project planning, registration risk assessment, compliance analysis, and project establishment evaluation. It is of utmost importance, accounting for 50% of the overall project. Proper planning and evaluation during this stage significantly contribute to the overall success of the registration project.
  2. Registration Project Management and Tracking: The second stage involves the practical implementation of the registration process. It accounts for 25% of the overall project and focuses on tasks such as sample preparation, test arrangement, test implementation, tracking, supervision, and obtaining test reports. Timely completion of tests and ensuring that the results meet the registration requirements are key objectives during this stage.
  3. Preparation, Compilation, and Registration Planning of Registration Dossiers: The final stage is dedicated to the preparation, compilation, organization, and evaluation of registration data in accordance with pesticide regulations and established criteria. This stage also involves providing scientific and rational explanations for any potential issues in the data or reports. The quality, completeness, and validity of the data, as well as the ability to address any concerns, significantly impact the final registration outcome. This stage holds a 25% importance in the overall project.

Stage 1: Planning and Evaluation

1.1 Product selection and market analysis

Start with the company’s core products and choose those with higher market demand. Analyze the company’s strengths and weaknesses based on the matching of the company’s industrial chain and product processes and conduct a market analysis considering the expected manufacturers and their capabilities. The market analysis should cover product characteristics, competitive products in the market, and the analysis of both the Chinese and global markets to identify the selling points of the product, the countries for intended registration, target crops, primary control pests and diseases, as well as the sales potential and market prospects of the product, and form a product market analysis report.

(1) Product characteristics, including insecticidal (or fungicidal/herbicidal) activity and spectrum, mode of action, crop safety, and other features.

(2) Product positioning, whether it aligns with market trends or occupies a unique position in a specific market segment.

(3) How to integrate the product with existing company products to develop a comprehensive crop protection solution or utilize different formulation mixtures to target different markets.

(4) Patent situation of imitation products. How to take advantage of the expiration or recent expiration of patents, as well as changes in strategies or adjustments by multinational companies, to expand market share.

(5) Analysis of competing products in the market. Compare the characteristics and competitive capabilities of the product with those of competing products.

(6) Analysis of the Chinese and global markets. Prepare a market analysis report for registration evaluation purposes.

1.2 Registration Pre-Risk Assessment and Compliance Analysis

According to the current “Requirements for Pesticide Registration Data,” an evaluation is conducted on the registration type, data requirements, testing cycles, the registration process, the review period, and overall registration costs to generate a registration compliance analysis report.

During the pre-risk assessment of the product, an evaluation and analysis is performed on toxicology, environmental behavior, and environmental toxicity based on overseas data on similar chemicals or compounds, as well as inference of the product’s environmental metabolism. In order to understand the health toxicological situation, environmental behavior and environmental toxicological situation. And conduct necessary toxicological tests, environmental behavior and environmental toxicological tests to conduct general toxicity evaluation of active ingredients. Comparative analysis of similar products should be carried out, make reasonable inferences about the main metabolites, infer the main impurities through the synthesis route, and use (Q)SAR, Read-across and data bridging to evaluate the genotoxicity of impurities and metabolites. Through the aforementioned pre-risk assessment, enterprises can understand product registration risks and registration success rates.

1.3 Project Planning and Project Evaluation for Registration

The company establishes a project plan and conducts project evaluation for all development and registration projects based on the annual sales amount, clearly defining the total development and registration costs for each year. Through project review and optimization, multiple registration projects are compared to increase the success rate of product registration, accelerate company profit growth, and enhance the competitiveness of company products in the market. This allows the company to allocate research and development expenses and registration costs more efficiently and effectively.

The registration project is proposed by the Marketing Department, and the registration and technology development project review team is composed of managers from each department of the company. The Product Manager proposes the projects to be registered and provides market analysis reports. The Registration Manager presents a compliance analysis report for each proposed registration project, providing detailed explanations of registration success rate, registration fees, and registration timelines. The actual deviation in registration fees represents a risk that may vary for each company but generally should not exceed 10-15%. The Finance Manager should represent the company in proposing the overall development and registration budget for each year. The project team should establish project review criteria based on the company’s situation for project evaluation. Projects can be classified and evaluated based on product, registration country, and registered crops, and recommendations for proposed registration projects and costs should be made. The final decision on registration projects and fees is generally made by the company’s top management. It is important to note the timing of the project establishment review when conducting the registration project establishment so that the project can be started immediately after project approval.

1.3.1 Market planning for pesticide registration projects

The market planning for pesticide registration projects involves conducting market analysis of the proposed registered products based on their characteristics, crop cultivation conditions, pesticide usage, and competition in each country. Based on the actual conditions in different countries, the company formulates sales and registration strategies to drive market positioning and plan market and brand promotion in the registration countries. Building on the market analysis, sales or international sales teams estimate the projected sales volume and revenue for each registered product within 5-10 years after registration, assess the input-output ratio, and evaluate the proposed registration projects for project initiation.

1.3.2 Registration planning for pesticide registration projects

The registration manager (or a senior registration consulting agency) should thoroughly plan the registration projects that the company needs to initiate. They should develop a registration plan in accordance with the registration data and review requirements of China (and other countries), and generate a compliance analysis report to improve the success rate of each project registration. When conducting registration planning, the following aspects should be considered:

    • Data gap analysis report.
    • Data preparation. Consider the time and sequence for preparing registration data in China and overseas. Based on the company’s budget, assess whether registration in China can be carried out simultaneously with other countries to shorten the registration timeline in core countries.
    • Laboratory and trial confirmation. When selecting laboratories for testing, consider OECD-GLP testing for overseas registration.
    • Establish registration timelines and project progress charts.

Stage 2: Registration Project Management and Tracking

Once a project is approved and initiated, it is necessary to prepare samples, select laboratories, and supervise experiments. When conducting experiments, it is important to audit and assess the Chinese GLP qualification of the laboratories, arrange Chinese GLP tests, and understand the test guidelines, review test protocols and test reports. Concurrently with conducting registration trials, project management and tracking should be initiated at any time. The registration manager should draft detailed plans for each registration project and provide monthly summaries of project progress, including reporting on expenditure, test progress, issues, and changes in Chinese pesticide registration policies. If the project encounters significant changes in Chinese registration policies or adverse effects from test results, the project team should promptly reassess the project. If there is a substantial change in the project success rate, the project should be halted or postponed. Likewise, if the registration fees exceed the company’s set standards or the registration timeline deviates significantly, the project should be stopped or postponed promptly.

Stage 3: Preparation, Compilation, and Registration Planning of Registration Dossiers

The preparation and compilation of registration dossiers are the final tasks before submitting a registration application. When preparing Chinese registration documents, attention should be paid to their completeness and scientific nature. It is important to have a thorough understanding of various aspects of the registration documents and the criteria for expert reviews. Anticipate potential issues and proactively provide explanations based on the characteristics of the entire product.

When conducting registration planning and estimating the registration timeline, it is necessary to consider the registration approval process and make a reasonable estimation and evaluation of the registration timeline. The registration of new pesticides is evaluated by the National Pesticide Registration Review Committee, which convenes meetings twice a year, typically in the middle and at the end of the year. Other types of registrations, including applications for registration of technical materials or formulations of new pesticides within the six-year protection period of the first registration, they are reviewed by the Executive Committee of the National Pesticide Registration Review Committee during their monthly meetings. Therefore, when evaluating the registration timeline for new pesticides and submitting registration dossiers, it is crucial to pay attention to the two annual meetings of the National Pesticide Registration Review Committee and plan the submission of registration documents accordingly, aiming at catching the nearest review meeting.

Related article: Strategies for China’s Pesticide Registration and Market Entry: Regulatory Changes – Part 1

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