Registration procedure for pesticides in China

Apr. 29th, 2011
1815

Registration Procedure for Pesticides in China

 

There are generally 3 phases for the registration of pesticides in China: Field Trial, Temporary Registration and Full Registration. Registration of a new pesticide, within a protection period or a new preparation, should apply for all these phases. If the applicant wants to skip the Field Trial and Temporary Registration phases, and apply for Full Registration directly, data is required for all these three phases and should be submitted all at once when applying for Full Registration.

Copies of data already provided in an application for a Field Trial and a Temporary Registration can be provided for Full Registration applicatons for a new product. For other registration types, these data can be waived based on a written explanation.

 

1) Pesticide Field Trial

The applicant needs to submit an Application Form for a Field Trial and apply for Field Trial approval. The Application Form should be correctly filled according to the data specified requirements under the Provisions on data requirements for Pesticide registration. For manufacturers established outside of China, the Application Form should be submitted directly to China Ministry of Agriculture (MOA). The Institute for the Control Agrochemicals, Ministry of Agriculture (ICAMA) was appointed to review the application materials, and the result will be provided within 3 months.
During this period, the product is not allowed to be placed on the market.

2) Pesticide Temporary Registration

After the Field Trial application is approved by the MOA, the applicant can conduct the Field Trial according to the national standard of China and the requirement of Pesticide Registration.

After the Field Trial is finished, the applicant should prepare the Application Form for Temporary Registration based on the result of Field Trial and submit it directly to the MOA. The MOA will review the application material and the result will be provided within 3 months.

A Temporary Registration number will be assigned after successful registration. The product can be placed on the market for trial sales, and Demonstration Field Trials (with field area lager than 10 ha.) are approved to be conducted after Temporary Registration. The validity period of Temporary Registration is 1 year. Applicants can submit material to apply for registration renewal within 1 year. The accumulated validity period shall not exceed four years.

3) Pesticide Full Registration

Manufacturers of pesticide products which can be placed on the market upon the result of demonstration field trials and trial sales shall apply for Formal Registration. The applicant shall prepare the Application Form for Full Registration and submit it to MOA. MOA will review the application materials and respond within 1 year.

A Full Registration number will be assigned after successful registration and the pesticide can be produced and placed on the market. The validity period of Temporary Registration is 5 years. The applicant can submit material to apply for registration renewal within the validity period.