Feb. 2nd, 2024

Agrochemical

Strategies for China's Pesticide Registration and Market Entry: Regulatory Changes - Part 1

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 one of an informative series, focusing on the upcoming regulatory changes that companies need to be aware of. To access part two, please click here, where we delve deeper into essential strategies for market entry.

Insights on the Chinese Pesticide Industry in 2023

In 2023, the Chinese pesticide industry experienced a transformative year marked by both challenges and opportunities.  Due to excessive production capacity in China and stockpiling by overseas customers during the epidemic, established pesticide products faced intense price competition in the Chinese market, resulting in reduced profitability and even losses. However, newly registered pesticide varieties that aligned with market demand were highly sought after by farmers, commanding higher prices and enjoying robust sales. To foster growth and expansion, pesticide companies require a continuous pipeline of newly registered products that cater to market needs. The registration and successful market entry of new products are key drivers for profit growth. Registering core products in China and key global markets is essential for maximizing company benefits. However, the development and registration of new pesticide products entail high costs and risks. Substantial financial investments are required for pesticide research and registration, and successful registration is necessary to ensure a return on investment. The duration of the registration process directly impacts product profitability. Therefore, pesticide companies need to pay special attention to risk mitigation strategies in innovative product development and registration.

Upcoming Changes in China’s Pesticide Regulations and Policies

In 2022, the State Council of China revised the "Regulations on Pesticide Management", the Pesticide Management Division of the Ministry of Agriculture and Rural Affairs (MoARA) successively released draft revisions for public consultation on the "Administrative Measures for Pesticide Registration," "Administrative Measures for Pesticide Production Permits," "Administrative Measures for Pesticide Labels and Instructions," "Administrative Measures for Pesticide Registration Trials," and "Administrative Measures for Pesticide Business Permits" between May and June 2023. The revised draft of the "Requirements for Pesticide Registration Documents" is awaiting publication. These drafts introduced significant changes compared to the existing regulations. The key aspects of these changes are as follows:
  1. Strengthening the Management of Pesticide Production Licenses
The revised draft of the "Administrative Measures for Pesticide Registration" clearly stipulates that, except for new pesticides, applicants for the registration of technical materials must provide a pesticide production license. For the formulation registration, except for new pesticide formulations or those exempted from the registration of technical materials, the technical materials (technical concentrate) used should have obtained the pesticide registration and the applicant must provide a pesticide production license. Registrations will not continue for those without a pesticide production license. If the scope of the production permit does not match the pesticide registration certificate, the registration will be suspended. If the scope of the corresponding production permit cannot be obtained within five years, the registration will not continue. It is explicitly stated that the production of the technical materials (technical concentrates) should not be outsourced. Restricted-use pesticides and pesticides limited to export only shall not be entrusted for processing or packaging.
  1. Enhanced Management of Registration Test Samples
Applicants or their agents (institutions) shall not conceal relevant information or submit false pesticide registration data and test samples. Provincial pesticide testing institutions shall assign dedicated personnel to the production line or pilot production line of the pesticide registration applicant to collect samples on-site and seal them, which will serve as materials for conducting tests and random inspections. Developers of new pesticides and overseas enterprises may provide sealed samples themselves. During the sealing process, the identification information of the sample provider should be verified for compliance. If the sample is sent by a third party, a letter of authorization from the pesticide registration applicant should be provided, and on-site verification by experts may be carried out as needed.
  1. Strengthening the Registration Management of Homogeneous Products
For applications for the registration of Me-too technical materials, Me-too formulation, or similar formulations, the reference product should have already obtained the pesticide registration.
  1. Management of Brand Logos or Trademarks on Pesticide Labels
Unregistered brand logos or trademarks shall not be used on pesticide labels and leaflets, and the same manufacturer can only use one brand logo or trademark.
  1. Transfer of Registration Licenses
In the event that an enterprise holding a pesticide registration license is merged and dissolved or relinquishes pesticide production, or when the results of a new pesticide developer are transferred, the registration licenses can be transferred to the acquiring or transferring enterprise. Both the acquiring and transferring parties should jointly submit an application to the Ministry of Agriculture and Rural Affairs, along with relevant supporting documents, to obtain a reissued pesticide registration license.
  1. Management of Laboratory Qualifications
If the qualification of a laboratory expires and is not re-applied for, or if a re-application is not approved, the pesticide registration test reports issued by the laboratory are considered invalid. During the rectification period of the laboratory, the laboratory's test data and test reports shall not be used as a basis for applying for pesticide registration.
  1. Authorization of Pesticide Registration Dossier
The holder of a pesticide registration license, who possesses complete registration data that meets the requirements, can authorize other applicants to use the data. If the same pesticide variety has undergone testing in three or more different testing institutions, the data from chronic toxicity and metabolite toxicity studies can be authorized separately. The cumulative authorization fees proposed by the same data owner should not exceed 70% of the total cost of the data testing fee. In the case of toxicological tests for the same metabolite conducted in three or more different testing institutions, an application for reduction or exemption can be made with the approval of the Pesticide Registration Review Committee.
  1. Overseas OECD-GLP Reports
Reports issued by overseas laboratories that have signed mutual recognition agreements with relevant departments in China can be accepted. However, tests closely related to environmental conditions, such as efficacy, residues, and environmental influence, as well as registration tests for China-specific biological species, should be conducted within China. For new pesticides that urgently need to be registered for pest control, the Ministry of Agriculture and Rural Affairs can accept test reports issued by overseas laboratories after expert evaluation, provided that they meet the relevant requirements of pesticide registration management. If foreign language documents are submitted, a Chinese translation should also be provided. Related article: Strategies for China’s Pesticide Registration and Market Entry: Research and Compliance – Part 2

Contact REACH24H

To benefit from our expertise in pesticide registration in China and ensure a smooth market entry, please contact us at your convenience. Our dedicated team is ready to assist you in navigating the regulatory landscape and seizing opportunities in this dynamic market.
  • Tel: +86 400 809 5809
  • Email: customer@reach24h.com

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