Navigating the application and approval process for pesticides can be a complex and time-sensitive endeavour. Understanding the procedures and timelines involved is crucial for companies aiming to bring their products to the Chinese market successfully. In this article, we will provide an overview of the registration application and approval process for pesticides in China, shedding light on the key steps and timelines involved.
Once a full set of pesticide registration data and information is prepared and the online registration dossier is completed, companies submit the registration materials to China’s Ministry of Agriculture and Rural Affairs (MoARA). The most important concerns after the preparation process above are the approval process, the timeline for approval, and when the official pesticide registration certificate can be obtained. The following information will address your questions:
New Pesticide Registration Application
For the registration of new pesticides, registration applications from overseas enterprises can skip the preliminary review process by the provincial authority and submit the application dossier to the MoARA for evaluation directly. However, for domestic applicants, registration materials should be preliminarily reviewed by the provincial agriculture and rural affairs department to examine the information pertaining to products within their jurisdiction. The preliminary review process will be completed within 20 working days, after which the department will provide preliminary comments and submit the materials to China’s MoARA.
After the application dossier is accepted by the MoARA, it will be subject to a 9-month technical review conducted by the Institute for Pesticide Control. Subsequently, the review comments will be submitted to the Pesticide Registration Review Committee for approval and the review opinions will be formed. The Pesticide Registration Review Committee holds two sessions per year, one in the middle of the year and one at the end of the year.
Once the MoARA receives the review opinions from the Pesticide Registration Review Committee, it will make an approval decision within 20 working days. The approval decisions will be posted on the official website for publicity for about one week.
Registration Application for Other Types of Pesticides
For pesticide registration applications for new formulations, new concentrations, new mixtures, new scopes of use, and new application methods, if overseas enterprises submit these applications, they can bypass the preliminary review of the provincial authority. Similarly, the applications submitted by domestic enterprises will first undergo preliminary review by the provincial agriculture and rural affairs department within their jurisdiction, within a time limit of 20 working days. After the preliminary review comments are provided, the applications will be submitted to the MoARA.
After the application is accepted by the MoARA, it undergoes a 9-month technical review conducted by the Institute for Pesticide Control. The technical review results will be submitted to the Executive Committee of the Pesticide Registration Review Committee for approval and review opinions will be generated. The Executive Committee Meeting is typically held once a month.
After receiving the review opinions from the Executive Committee, the MoARA will make an approval decision within 20 working days. The approval decisions will be posted on the official website for publicity for about one week.
Pesticide Registration Modification Application
When applying for registration modifications such as expanding the scope of use, changing application methods, or increasing dosage, etc. after the MoARA accepts the application, the Institute for Pesticide Control will conduct a technical review within 6 months. The review will be submitted to the Executive Committee of Pesticide Registration Review Committee for approval and the review opinions will be generated.
After receiving the review opinions from the Executive Committee, the MoARA will make an approval decision within 20 working days. The approval decisions will be posted on the official website for publicity for about one week.
Obtaining the Registration Certificate
After completing the approval process in the administrative approval office, a double review will be conducted on the approval decision. If the double review is passed, the completion notice will be issued and feedback will be provided to the applicant through the online approval system. If it does not pass the double review, it will be returned to the Department of Plantation Management for further processing. If it is not approved, a written notice will be delivered to the applicant. The process will be completed within 2 working days.
Upon receiving the feedback of approval, the Institute for Pesticide Control will produce the pesticide registration certificate within 10 working days and deliver it to the applicant.
In conclusion, navigating the registration and approval process for pesticides in China requires careful adherence to the outlined procedures and timelines. Timely and accurate submission of registration materials is essential to ensure smooth progress throughout the process.
At REACH24H Consulting Group, we specialize in registration and regulatory consulting services, providing comprehensive support to companies seeking to navigate the complex landscape of pesticide registration in China.
