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New pesticide registration in China
Legal overview

China's new pesticide registration refers to pesticides containing active ingredients that have not been approved and registered in China, including new pesticide active drugs (mother drugs) and new pesticide preparations. When applying for new pesticide registration according to the "Measures for the Administration of Pesticide Registration", the application for registration of new pesticide original drug and new pesticide preparation shall be submitted at the same time, and the pesticide standard product shall be provided.

Since the implementation of the new "Pesticide Registration Data Requirements", China's pesticide registration has become a risk-oriented pesticide safety assessment strategy, adding many test data requirements, pesticide safety assessment cycle is long, and the current registration cost of new pesticides in China is high and uncertain. There is a certain inhibition on new pesticide registration. However, pesticide enterprises have internal motivation for new pesticide registration.

 
Registration process

1. Apply to the National Technical Committee for Pesticide Standardization for the Chinese generic name of the new ingredient.

2. Complete the application for new active ingredient name information to be stored on the government affairs service platform of the Ministry of Agriculture. The official commitment of the new active ingredient name information into the database is completed within 3 months.

3. Apply for test sample seal in the provincial agricultural department where the applicant is located. When sealing samples, it is generally necessary to fill in the sealing sample registration form as required, and provide the sample quality conformity test report and related spectrum diagram. The applicant shall be responsible for the authenticity and consistency of the test samples.

4, Before the start of the test, the test was recorded through the China pesticide digital supervision platform.

5, apply for formal registration. Domestic applicants apply for new pesticide registration to provincial agricultural departments, and overseas enterprises directly apply to the Ministry of Agriculture and Rural Affairs. To apply for new pesticide registration, the application for new active drug and new preparation should be submitted at the same time, and standards should be provided, including 2 grams of active ingredient standard, 0.5 grams of major metabolites and related impurities standard, 100 grams (ml) of the original drug/mother drug sample, and 250 grams (ml) of the preparation sample.

 
Registration period

The registration cycle of new pesticides generally takes about 4 years, and the time required for different types of pesticides will vary.

In addition, the Ministry of Agriculture and Rural Affairs began to implement green channel management measures for pesticide registration and approval in October 2020, and for new pesticides of biological origin and antibiotics, enterprises can submit a written application for accelerated registration and approval. In the case of meeting the requirements, the official will give priority to technical review, shorten the registration cycle, and speed up the market cycle of new products.

 
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