Navigating New Pesticide Registration in China: Process, Challenges, and Strategies
What is a New Pesticide?
A new pesticide refers to a pesticide whose active ingredient has not yet been approved for registration in China. This includes both new pesticide technical material (the “technical concentrate“) and new pesticide formulations.
Under the “Pesticide Registration Management Measures” when applying for new pesticide registration, both the technical material and the pesticide formulation must be submitted along with the relevant pesticide reference standards.
Since the implementation of the new Pesticide Registration Data Requirements, China’s new pesticide registration has adopted a risk-based safety evaluation strategy, which has led to additional testing requirements. The safety evaluation cycle for pesticides has also lengthened. As a result, the costs for registering new pesticides in China are high and uncertain. Although these factors may hinder registration, pesticide companies still have a strong motivation to pursue the registration of new pesticides.
New Pesticide Registration Process in China
Application for the Common Name
Submit an application for the Chinese common name of the new active ingredient to the National Pesticide Standardization Technical Committee.
Entry of Active Ingredient Name into the System
On the Ministry of Agriculture’s online platform, submit the new active ingredient’s name for official registration. The Ministry guarantees that the registration process will be completed within 3 months.
Sample Sealing
Apply to the provincial agricultural department for sample sealing. When sealing, the applicant must submit a sample registration form, a quality conformity test report, and relevant spectra. The applicant is responsible for ensuring the authenticity and consistency of the sample.
Test Project Filing
Before testing begins, file the test project through the China Pesticide Digital Supervision & Management Platform.
Formal Registration Application
Domestic applicants submit their new pesticide registration application to the provincial agricultural department, while foreign companies apply directly to the Ministry of Agriculture and Rural Affairs. Applicants must submit both the technical material and formulation registration applications, as well as reference standards, which include 2g of active ingredient, 0.5g of major metabolites and related impurities, 100g (ml) of the technical material, and 250g (ml) of the formulation.
New Pesticide Registration Cycle in China
The registration cycle for new pesticides generally takes about four years, although this can vary depending on the type of pesticide.
Additionally, since October 2020, the Ministry of Agriculture has implemented a green channel for registration approval for biological and antibiotic-based pesticides. If companies submit a written request for expedited approval, the Ministry may prioritize technical reviews and shorten the registration cycle, helping companies bring new products to market more quickly.
Key Points for New Pesticide Registration in China
Registering new pesticides in China can be costly, risky, and time-consuming. To improve the chances of success in the registration process, companies should focus on three key stages:
Accurate Project Assessment and Risk Evaluation
Conduct a risk assessment of the registration project to evaluate its likelihood of success.
Full Process Supervision of Testing
This includes the preparation and sealing of samples, selecting testing laboratories, filing test records, signing testing contracts, reviewing test plans, overseeing the testing process, and auditing the test reports to ensure timely collection. Since testing involves various areas such as product chemistry, toxicity, efficacy, residue, ecotoxicology, and environmental behavior, it requires expert oversight in these fields to minimize adverse results, which could hinder registration in China or globally.
Compilation and Review of Registration Data
Carefully organize and summarize the registration data and address any issues with scientific explanations, ensuring the registration dossier is complete and scientifically sound.
How Can Companies Do for New Pesticide Registration in China?
Risk Assessment and Planning
A comprehensive new pesticide registration plan should begin with an evaluation of the likelihood of success and a risk assessment of the project. This helps in determining the necessary resources and managing risks throughout the registration process.
Estimated Costs and Timelines
Companies should accurately forecast registration costs and timelines. Market research and sales forecasting are also essential for assessing potential returns once the product is launched. If registration costs or timelines deviate significantly, companies should re-evaluate the project.
Comprehensive Project Supervision
Companies should ensure full supervision of the entire process, including test design, regulatory compliance, and data collection. This helps mitigate risks and increases the likelihood of successful registration.
Recent Trends in Pesticide Registration
In 2020 and 2021, 21 new pesticides were registered in China. Of these, 4 were chemical pesticides, and 17 were biological pesticides. The new chemical pesticides included the domestic innovations quinotrione and tiorantraniliprole, as well as prothioconazole and tembotrione, which are products of expiring Bayer patents. Many domestic companies pursued registration for these patents under the new regulations, but the success rate has remained low.
Strategies for Domestic Companies
Risk Evaluation for Innovative Pesticides
Domestic companies should conduct thorough risk assessments and market analysis before registering new pesticides. For completely new chemicals, estimating testing costs and timelines is challenging, so flexibility should be built into the registration planning process.
Strategies for Patented Products
Companies should take into account the existing registration status in other markets like the EU, the US, and Japan when considering registration for products with expiring patents. Domestic registration standards may differ from those of other regions, which requires careful planning.
Strategies for International Companies
Due to the issues surrounding the recognition of Chinese GLP data and OECD-GLP data, foreign companies are still required to conduct full testing in China to register new pesticides, which significantly increases costs.
In 2020 and 2021, only 6 new pesticides (5 chemical and 1 biological) were registered by international companies. The number of registrations has declined, and the success rate has also dropped. However, as the Chinese market remains crucial for global sales, international companies cannot afford to ignore registration in China.
Handling Existing Data from Other Markets
If foreign companies have registered their products in the EU, the US, or Japan, they may face challenges in meeting China’s specific registration requirements. Therefore, they must plan for supplementary testing and data submission to comply with Chinese standards.
Pre-emptive Registration in China
International companies should consider registering products specifically for the Chinese market. This requires careful planning, testing arrangements, and a strong understanding of Chinese regulatory policies.
Challenges in China’s New Pesticide Registration
Toxicology Data for Major Metabolites
New pesticide registration in China requires the submission of toxicological data for major metabolites. This includes acute toxicity, AMES testing, chromosomal aberration, gene mutation tests, and 90-day subchronic toxicity tests. These tests are time-consuming and expensive, and the synthesis of metabolites can be challenging, leading to significant delays.
Mutual Recognition of GLP Data
Currently, China does not recognize OECD-GLP data, meaning that foreign companies must conduct testing in China according to domestic GLP standards. This adds considerable cost to the registration process. However, discussions are underway to improve the mutual recognition of GLP data, which would streamline the registration process and make it easier for international companies to register their products in China.
About REACH24H
REACH24H has been deeply involved in pesticide registration for many years and has rich experience and successful cases, especially with regard to the registration of new pesticides. We specialize in pesticide efficacy testing design, risk assessment, metabolite identification, trial monitoring, and other key steps in the registration process. We offer comprehensive solutions to address the challenges in the pesticide registration process in China.
