According to the "Pesticide Registration Data Requirements", the registration of chemical pesticide active drug (mother drug) is divided into new pesticide active drug (mother drug) registration, non-identical active drug (mother drug) registration and the same active drug (mother drug) registration. Among them, the registration of the same active drug (mother drug) compared with the registration of new pesticide active drug (mother drug) and non-identical active drug (mother drug), the registration test data requirements and costs are much less, and the registration cycle is shortened from about 4 years to about 1 year.

If you want to register the same original drug, you should mainly follow the Annex 10 of the "Requirements for Pesticide Registration Data" “ Standard for identification of the same pesticide ” It is required to do a good job in several aspects such as the approval of the registration requirements of the same original drug, the identification and judgment of the same original drug data and the preparation of the same original drug registration data, and pay attention to the approval process of the pesticide inspection Institute of the Ministry of Agriculture and Rural Affairs to improve the success rate of registration.

According to Annex 10 of the Pesticide Registration Data Requirements “ Standard for identification of the same pesticide ” Requirements, the same drug data identification according to two stages. The first stage is the identification of product chemical data, and the second stage is the identification of toxicological data and environmental impact data.

Product chemical data identification

Compared with the control product (M1, the same below), when the application for recognition of the product (M2, the same below) meets all the following requirements, M2 and M1 can be identified as the same original drug.

01: the active component content of M2 is not lower than M1;

02: The limit of M2 related impurities is not higher than M1;

03: M2 other main project control index is not lower than M1;

04: Compared with M1, M2 has no new related impurities;

05: Compared with M1, the relative value of M2 non-correlated impurity limit increased by no more than 50% or the absolute value increased by no more than 0.3%.

06: Compared with M1, M2 has no new non-related impurities;

07: M2 Salmonella Typhimurium/back mutation test results, equal to or better than M1. When any of the requirements of 1, 3 and 7 are not met, M2 is identified as a different original drug. When the requirements of 1, 3 and 7 are met at the same time, but any of the requirements of 2, 4, 5 and 6 are not met, the second stage shall be identified.

M1 Production enterprise name and registration certificate number.

M2 production process, complete component analysis report, physical and chemical properties, product quality specifications, Salmonella Typhimurium/back mutation test data.

When the pesticide inspection Office of the Ministry of Agriculture and Rural Affairs reviews the registration data of the same original drug, the Quality Review Office, the Toxicology Review Office and the Environmental Review Office shall respectively give the same judgment conclusions while putting forward the professional review opinions; During the comprehensive review, the drug Administration shall summarize the peer judgment conclusions of quality, toxicology and environment, and put forward the same product identification opinions and comprehensive review opinions.

Therefore, when preparing the registration data of the same original drug, it is necessary to make a judgment of the same original drug and prepare a full set of the registration data of the same original drug to ensure the success of registration