How to Register for Me-Too Technical Material Under China New Pesticide Regulation?
According to the Pesticide Registration Data Requirements, the registration of chemical pesticide technical material (technical concentrate) is divided into the registration of new pesticide technical material (TC), the registration of non-identical technical material (TC) and the registration of me-too technical material (TC). Compared with the registration of new and non-identical TC, the registration of me-too technical material requires fewer test data and expenses, and the corresponding registration period is shortened from four years to about one year.
To complete a successful me-too technical material registration, the requirements of Annex 10 Guidance on Equivalence Assessment of TC in the Pesticide Registration Data Requirements should be followed. You need to review the me-too TC registration requirements, assess registration data and prepare registration data for me-too TC registration, and keep an eye on the approval process of ICAMA (Institute for the Control of Agrochemicals) of MOA (Ministry of Agriculture and Rural Affairs) to increase the possibility of successful registration.
Registration Requirements of Me-Too Technical Material
When selecting the me-too pesticide variety, it is necessary to select the pesticide variety of which the 6-year protection period of its first registration has expired, and the control TC applied for the me-too TC registration application should be a TC registered according to the new Pesticide Registration Data Requirements.
Assessment Rules of Technical Equivalence
According to the requirements of Annex 10 Guidance on Equivalence Assessment of TC of the Pesticide Registration Data Requirements, the assessment of technical equivalence data is carried out in two stages. The first stage is the assessment of product chemical data, and the second stage is the assessment of toxicological data and environmental impact data.
Assessment of product chemical data
Compared with the control technical material (M1, the same below), when the technical material applying for assessment (M2, the same below) meets all the following requirements, it can be determined that M2 and M1 are technical equivalence.
- The active ingredient content of M2 is not less than that of M1;
- The limit of relevant impurities of M2 is not higher than M1;
- Control indicators of other major items of M2 are not lower than M1;
- Compared with M1, M2 has no new relevant impurities;
- Compared with M1, the relative value of M2 non-relevant impurity limit increases by no more than 50% or the absolute value increases by no more than 0.3%, and the larger value prevails;
- Compared with M1, M2 has no new non-relevant impurities;
- The salmonella typhimurium/reverse mutation test result of M2 is equal to or better than M1.
When it doesn’t meet any of the requirements in 1.1.1, 1.1.3, and 1.1.7, M2 is considered to be a non-identical technical material.
When it meets all the requirements of 1.1.1, 1.1.3 and 1.1.7, but doesn’t meet any of the requirements of 1.1.2, 1.1.4, 1.1.5 or 1.1.6, the second stage assessment shall be carried out.
Toxicology and environmental impact data assessment
- Toxicology data
Comparing the toxicological test results of M2 with the corresponding test results of M1, the coefficient of acute toxicity test results is not more than 2 (or more than 2, but does not exceed the reasonable test dose growth coefficient), and the evaluation conclusions of positive and negative results are consistent, then it is considered that the toxicological data are equivalent.
If it cannot be determined that the toxicological data of M2 and M1 are equivalent according to the results of the acute toxicity test, it is necessary to evaluate the results of repeated administration tests (from subacute to chronic toxicity test) and reproductive toxicity, mutagenicity, carcinogenicity and other tests, and determine according to the principles of 2.1.1. If the toxic effector organs are the same, and the change of NOELs and NOAELs does not exceed the change of dose level, it is considered that the toxicological data are equivalent.
- Assessment of environmental impact data
In the context that the test organisms are the same, the results of bird acute oral toxicity tests, fish acute toxicity tests, daphnia magna acute activity inhibition test, bee acute contact toxicity test, and silkworm acute toxicity test for M1 shall be taken as a reference when comparing the test results of the corresponding items of M2 and M1, and the coefficient is not more than 5 (or more than 5, but does not exceed the reasonable test dose growth coefficient), it can be concluded that the environmental impact data of M2 and M1 are equivalent.
Requirements for Registration Data of the Technical Equivalent Material
- Name of M1 manufacturer and registration certificate number.
- Production process, analysis report of all components, physical and chemical properties, product quality specifications, Salmonella typhimurium/reverse mutation test data on M2.
Provide M2 toxicology and environmental impact data as needed
- Acute oral, percutaneous and inhalation toxicity test, eye irritation test, skin irritation test and skin sensitization test.
- Subchronic (acute) toxicity test (90-day rat feeding test is required. 28-day percutaneous or 28-day inhalation toxicity test, mutagenicity test, in vitro mammalian cell gene mutation test, in vitro mammalian cell chromosome aberration test and in vivo mammalian bone marrow cell micronucleus test shall also be provided based on the product characteristics, .
Environmental impact data
- It includes bird acute oral toxicity test, fish acute toxicity test, daphnia magna acute activity inhibition test, bee acute contact toxicity test, and silkworm acute toxicity test.
- If it is authorized by the holder of the M1 registration certificate, the original letter of authorization signed by the legal representative of the authorization party and stamped with the official seal shall also be provided.
Approval Process of Technical Equivalent Data
When the Institute for the Control of Agrochemicals, Ministry of Agriculture (ICAMA) of the Ministry of Agriculture (MOA) reviews the registration data of me-too technical materials, the Quality Assessment Office, the Toxicology Assessment Office and the Environmental Assessment Office shall give their equivalence conclusions and professional review opinions. During the comprehensive review, the Drug Administration Department will summarize the equivalence conclusions of quality, toxicology and environment office, and provide equivalence assessment opinions and comprehensive review opinions.
Therefore, when preparing the registration data of me-too technical material, assessment of technical equivalence and preparation of a set of registration data must be completed properly to raise the possibility of successful registration.
REACH24H Consulting Group has been working on pesticide registration in China for many years, especially for the current new pesticide registration. With rich experience and many successful cases, we could offer our expertise during the whole process of pesticide registration in China, including trial efficacy test design, risk assessment, metabolite identification, and experiment supervision.
If you have any questions, please don’t hesitate to contact us.
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