Thinking and practice of new pesticide registration and listing in China

In 2023, China's pesticide enterprises experienced a very special year, many old pesticide products due to China's excessive production capacity, overseas customers during the epidemic stock, resulting in fierce price competition in the domestic market, lower and lower profits, and some varieties even sold at a loss. But at the same time, we also see that some new pesticide varieties that are urgently needed in the market are welcomed by farmers after registration under the New Deal, and the market sales are good and the price is high.

Pesticide enterprises only have a steady stream of new product registration on the right market, the company can develop and grow, and the registration and sale of new products is the company's profit growth point. The registration and layout of core products in China and key global markets can bring maximum benefits to the company. However, the research and development and registration of new pesticide products are costly and risky, and the research and development and registration of pesticides need to invest a lot of funds, and only the successful registration can ensure the recovery of funds. The length of registration determines the profit of the product. How to avoid the risk of innovative product development and registration is a matter that pesticide enterprises should pay special attention to in the development and registration of new pesticides.

Learn about upcoming changes to pesticide management regulations and policies

After The State Council revised the "Regulations on Pesticide Management" in 2022, the Department of Pesticide Management of the Ministry of Agriculture and Rural Affairs successively issued the revised draft of the "Measures for the Management of Pesticide Registration", "Measures for the Management of Pesticide Production Licensing", "Measures for the Management of Pesticide Labels and Instructions", "Measures for the Management of Pesticide Registration Tests" and "Measures for the Management of Pesticide Business Licensing" in May and June 2023. The revised draft of Pesticide Registration Data Requirements is waiting for release. Compared with the current implementation of the content released by the five methods, there are changes in the following aspects:

1. Strengthen the management of pesticide production license

The draft for comments on the revision of the Measures for the Administration of Pesticide Registration clearly stipulates that in addition to new pesticides, the application for the registration of the original drug requires the production license of the original drug. In addition to the registration of new pesticide preparations or exemption from the registration of the original drug (mother drug), the application for registration of preparations, the original drug (mother drug) used should obtain pesticide registration, and the production license of the original drug is required. Without a pesticide production license, the registration shall not be renewed. If the scope of the production license is inconsistent with the pesticide registration certificate, the registration shall be suspended; If the production license scope cannot be obtained within 5 years, the registration shall not be renewed. It is clear that the original medicine (mother medicine) shall not be commissioned for production. Limit the use of pesticides, only export pesticides shall not be commissioned processing or packaging.

2 Strengthen the management of registered test samples

The applicant or agent (agency) shall not conceal the relevant information or submit false pesticide registration information and test samples. According to the needs of the pesticide registration applicant to carry out registration tests, the provincial pesticide verification institution should assign special personnel to the pesticide registration applicant's production line or pilot production line to take samples on-site and seal the samples as materials for testing and sampling inspection. New pesticide researchers and overseas enterprises can provide their own sealed samples. When sealing the sample, the conformity of the identity information of the sample sender should be checked, and those who entrust others to deliver the sample should provide the power of attorney of the pesticide registration applicant, and experts can be appointed for on-site verification according to needs.

3. Strengthen the registration management of homogeneous products

When applying for the registration of the same original drug, the same preparation or similar preparation, the pesticide registration test record, its control product should have obtained pesticide registration.

4 Management of brand logos or trademarks in pesticide labels

Pesticide labels and instructions shall not use unregistered brand logos or trademarks, and only one brand logo or trademark may be used by the same manufacturer.

5 Transfer of registration certificate

If the enterprise holding the pesticide registration certificate is cancelled or abandoned by the merger of pesticide production, the transformation of the results of new pesticide researchers, the registration certificate can be transferred to the merger enterprise or transformation enterprise, the merger and transformation parties shall jointly apply to the Ministry of Agriculture and Rural Affairs, submit relevant certification materials, and replace the pesticide registration certificate.

6. Laboratory qualification management

If the laboratory fails to re-apply or fails to pass the re-application after the expiration of the laboratory qualification, the pesticide registration test report issued is invalid. During the rectification period, the test data and test report shall not be used as the basis for applying for pesticide registration.

7 Pesticide registration data authorization

The complete registration data independently owned by the holder of the pesticide registration certificate meeting the registration data requirements may be authorized to be used by other applicants. If the same pesticide variety has completed more than 3 tests in different testing institutions, its chronic toxicology and metabolite toxicology test data can be authorized separately. The cumulative authorization fee of the same data owner shall not exceed 70% of the total authorization data test fee. If the toxicology test of the same metabolite has been completed more than 3 times in different testing institutions, it can apply for remission after the approval of the pesticide registration Review committee.

8 Overseas OECD-GLP report

It can be issued by relevant overseas laboratories that have signed mutual recognition agreements with relevant Chinese departments; However, tests that are closely related to environmental conditions, such as efficacy, residue and environmental impact, as well as registration tests of endemic biological species in China shall be completed within China. Due to the urgent need to accelerate the registration of new pesticides for the prevention and control of pests and diseases, the Ministry of Agriculture and Rural Affairs can use the test report issued by relevant overseas laboratories after expert evaluation, and meet the relevant requirements of pesticide registration management. Where materials in foreign languages are submitted, Chinese translation shall be provided at the same time.

Planning, project establishment and project implementation before new pesticide registration

Pesticide registration in China is divided into three stages. The first stage is the pre-project planning, including product selection and product market analysis, project planning, registration risk assessment and registration compliance analysis, and project evaluation. This stage plays a very important role in the success of the whole project and should account for 50% of the whole project. Phase 2 starts registration and implementation, which mainly involves the preparation of test samples, test arrangement and implementation, tracking, supervision and obtaining of test reports. Whether the test can be completed on time at this stage and whether the test results meet the registration requirements should account for 25% of the whole project. The third stage is to prepare, summarize and sort out the registration data after receiving the test report in accordance with the pesticide management regulations, registration data requirements and the evaluation standards of the pesticide inspection Institute of the Ministry of Agriculture and Rural areas, and find out the problems that may be explained by the data/report, so as to make scientific and reasonable explanations in advance. The preparation of registration data at this stage is also crucial to the final registration result. The integrity of the registration data, the scientific nature of the data, the possible problems in the data whether there is an explanation will affect the registration results, and this stage should also account for 25% of the entire project.

1 How to plan before registration of new pesticides

1.1 Product selection and market analysis

Starting from the company's core products, select the products with high market heat, analyze the company's advantages and disadvantages according to the matching situation of the company's industrial chain and the product process, analyze the product market combined with the expected manufacturers, and analyze the market from the product characteristics, market competition and the Chinese and global markets. Find out the selling point of the product, the country to be registered, the crop, the main control object, and the post-market sales and market potential of the product, and form a product market analysis report.

(1) Product characteristics, that is, the product's insecticidal (or bactericidal/herbicidal) activity and insecticidal (or bactericidal/herbicidal) spectrum, mechanism of action, crop safety and other characteristics.

(2) Product positioning, whether it is the market direction or the champion in a certain market area.

(3) How to cooperate with the company's existing products to develop the market, form a certain crop whole-process control, or use different mixed preparations to develop different markets.

(4) Patent situation of imitation products. How to take advantage of patent expiration or just expired time and multinational company strategy adjustment or change to grow the market.

(5) The situation of competitive products in the market, and the characteristics and competitiveness of the product are compared with those of competitive products.

(6) China and global market analysis. Prepare market analysis report for registration and evaluation.

1.2 Pre-registration risk assessment and compliance analysis

According to the current "Pesticide Registration Data Requirements", the product registration type, data requirements, test cycle, registration process, review cycle and overall registration costs are evaluated to form a registration compliance analysis report. In the pre-risk assessment of products, toxicology, environmental behavior and environmental toxicology should be evaluated and analyzed based on foreign data of similar chemicals or compounds, as well as the inference of the product's environmental metabolism. Understanding health toxicology, environmental behavior, and environmental toxicology. Necessary toxicological tests, environmental behavior tests and environmental toxicological tests were carried out to evaluate the general toxicity of active ingredients. Comparative analysis of similar products was conducted to rationally infer major metabolites, and major impurities were inferred through synthetic routes, and the genotoxicity of impurities and metabolites was evaluated by means of (Q)SAR, Read-across and data bridging. Through the above pre-registration risk assessment, understand the product registration risk and registration success rate.

1.3 Register project planning and project evaluation

The company defines the total annual development and registration costs based on sales, and reviews and optimizes all development and registration projects. Through project review and optimization, multiple registered projects are compared, so that the success rate of product registration is higher, the company's profit growth is faster and the company's products are more competitive in the market. Let companies use research and development costs and registration costs more rationally.

The registration project is proposed by the Marketing Department, and the registration and technology development project review team is composed of the managers of each department of the company. The product manager presents the project to be registered and the market analysis report. The registration manager puts forward a compliance analysis report for each project to be registered, and gives a detailed description of the registration success rate, registration cost and registration cycle. The actual registration cost deviation may be different for each company, but generally cannot exceed 10% to 15%. The financial Manager shall, on behalf of the company, propose the annual general development and registration budget. The project team shall set project evaluation criteria according to the situation of the company in order to evaluate the project. The project can be classified and evaluated by product, registered country and registered crop, and propose the project to be registered and the cost. Registration items are generally made by the company's senior management to make the final decision on registration items and costs. When registering a project, it is necessary to pay attention to the review time of the project, so that the project can be started immediately after the project is approved.

(1) Market planning for pesticide registration projects

The market planning of the registration project mainly analyzes the market of the products to be registered according to the characteristics of the products and the crop planting situation of each country, the use of pesticides and the situation of competitive products. Formulate company sales and registration strategies according to the actual situation of each country to promote the market layout, plan the market and brand promotion in the registered country. On the basis of market analysis, the input-output ratio has been evaluated with the estimated sales volume and sales volume of 5 to 10 years after the completion of the registration of each project to be registered by sales or overseas sales, so as to evaluate the registration of the project to be registered.

(2) Registration planning of pesticide registration projects

The registration manager (or ask a senior registration consulting agency) to make a full plan for the registered projects to be established by the company, make a good registration plan according to the registration data requirements and review requirements of China (taking into account other countries), form a registration compliance analysis report, and improve the success rate of each project registration. When planning for registration, the following aspects should be considered:

❖ Data Gap Analysis report.

❖ Data preparation. It is necessary to consider the preparation time and sequence of Chinese registration data and overseas registration data, and according to the company's budget, consider whether Chinese registration can be carried out at the same time as other countries to shorten the registration time in core countries.

❖ Laboratory and test validation. When selecting laboratories for testing, consideration should be given to OECD-GLP tests registered abroad.

❖ Develop registration cycles and project progress tables.

2 Register project management and tracking

Once the project is approved and started, sample preparation, laboratory selection and test supervision should be carried out. During the test, the China-GLP qualification of the laboratory should be reviewed and evaluated, the China-GLP test should be arranged, the test criteria should be understood, and the test plan and test report should be reviewed. At the same time of carrying out the registration test, the project management and tracking should be carried out immediately. The registration manager should draft the detailed plan of each registration project, summarize the progress of the project every month, and report the cost expenditure, the progress and problems of the test, as well as the changes in China's pesticide registration policy. If the project encounters major changes in China's registration policies or adverse effects of test results, the project team shall re-evaluate the project or affected projects as soon as possible. If the success rate of the project changes dramatically, the project implementation shall be stopped or postponed as soon as possible. If the registration fee increases beyond the standard set by the company or the registration cycle deviates too much, the project should be stopped or postponed as soon as possible.

3. Preparation, preparation and registration planning of registration materials

The preparation and compilation of registration information is the final work before registration application, and attention should be paid to the integrity and scientificity of registration information when preparing Chinese registration information. System to understand all aspects of product registration information and expert review standards, predict possible problems, from the characteristics of the entire product, early response explanation.

When planning the registration and estimating the registration cycle, the registration cycle should be reasonably estimated and evaluated in combination with the registration approval procedures. The new pesticide registration is reviewed by the National Pesticide Registration and Review Committee, which meets twice a year at the middle and end of the year; Other types of registration, including the first registration within 6 years of protection in accordance with the requirements of new pesticide active drug or new pesticide preparation registration data to apply for registration of active drug or preparation by the national pesticide Registration and Review Committee executive Committee review, held once a month. Therefore, when evaluating the new pesticide registration cycle and submitting registration data, we must pay attention to the meeting time of the members of the National Pesticide Registration Review Committee twice a year, plan the time of registration data submission, and strive to catch up with the latest national pesticide Registration Review Committee review.