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The registration category of micro-optimization of dosage forms in pesticide declaration and registration refers to the company's micro-optimization of the registered product dosage forms, which is more conducive to the effectiveness of the drug and environmental protection, while the type and content (proportion) of the active ingredients remain unchanged
.
The minor optimization of the dosage form in pesticide registration includes: (1) Wettable powder (WP) becomes water dispersible granules (WG); (2) Emulsifiable concentrate (EC) becomes water emulsion (EW) or oil emulsion (OW) Or microemulsion (ME) (but not containing a large amount of organic solvent); (3) Change from soluble powder (SP) to soluble granule (SG); (4) Change from granule (GR) to fine granule (FG) or microparticles (MG); (5) Others
.
Apply for product registration according to the small optimization category of dosage form: The data requirements of product chemistry are consistent with the new dosage form.
The company needs to provide product abstracts, product chemistry abstracts, product standards and preparation instructions, quality inspection and method verification reports, 2-year room temperature storage reports, product physicochemicals Property report and other information; Toxicological information, generally required to provide acute oral, transdermal, inhalation, eye irritation, skin irritation, skin sensitization and acute six test data; field effect test data, when the optimized product contains new When registering the scope of use or a new registration method of use, the efficacy data needs to be submitted in accordance with the requirements of the new dosage form, that is, ① the indoor activity test report needs to be submitted for the products involving the new control target; ② the product involving the new scope of use needs to be submitted Indoor safety test report for current test crops; ③ For compound preparations, it is necessary to submit a description of the purpose of mixing and an indoor formula screening report.
The above-mentioned ①②③ materials need to be submitted in the field effect test application stage, and only need to be submitted in the formal registration application Copy
.
Field effect test reports shall be provided in accordance with: (a) Pesticides and fungicides shall be provided in 4 or more provincial administrative regions within the territory of China for field plot efficacy test reports for more than 2 years; (b) Herbicides and plant growth regulators shall be provided In the field of 5 or more provincial administrative regions in China, the efficacy test report of the field community for more than 2 years, for long-residual herbicides, the safety test report for the main subsequent crops should also be provided; (c) planted in some areas Crops (such as flax, sugar beet, oil sunflower, ginseng, rubber tree, lychee tree, longan tree, banana, mango tree, etc.
) or diseases, insects, and weeds that occur in local areas, can provide more than 3 provincial administrative regions, Field community efficacy test report for more than 2 years; (d) For some special agents, such as biocidal herbicides, we can provide field community efficacy test reports for more than 3 provincial administrative regions and more than 2 years; (e) For pesticides used in places with relatively stable environmental conditions, such as pesticides for storage, antiseptic, and fresh-keeping, we can provide efficacy test reports in more than 2 provincial administrative regions in China with more than 2 test cycles
.
The residual test data that needs to be submitted in the small optimization registration category of the dosage form need to distinguish whether the active ingredient has passed the protection period of the new pesticide or the protection period of the official registration
.
The environmental impact test data is consistent with the environmental data requirements of the new dosage form registration category
.
However, when the company has the required environmental data for the registered dosage form corresponding to the micro-optimization of the dosage form, it can provide environmental summary data
.
However, when the newly registered crops or usage methods of the pesticide formulation micro-optimization product, and the environmental impact data provided by the original formulation registration cannot meet the requirements of environmental safety assessment, the corresponding environmental impact data should be provided in accordance with the requirements of the new formulation
.
.
The minor optimization of the dosage form in pesticide registration includes: (1) Wettable powder (WP) becomes water dispersible granules (WG); (2) Emulsifiable concentrate (EC) becomes water emulsion (EW) or oil emulsion (OW) Or microemulsion (ME) (but not containing a large amount of organic solvent); (3) Change from soluble powder (SP) to soluble granule (SG); (4) Change from granule (GR) to fine granule (FG) or microparticles (MG); (5) Others
.
Apply for product registration according to the small optimization category of dosage form: The data requirements of product chemistry are consistent with the new dosage form.
The company needs to provide product abstracts, product chemistry abstracts, product standards and preparation instructions, quality inspection and method verification reports, 2-year room temperature storage reports, product physicochemicals Property report and other information; Toxicological information, generally required to provide acute oral, transdermal, inhalation, eye irritation, skin irritation, skin sensitization and acute six test data; field effect test data, when the optimized product contains new When registering the scope of use or a new registration method of use, the efficacy data needs to be submitted in accordance with the requirements of the new dosage form, that is, ① the indoor activity test report needs to be submitted for the products involving the new control target; ② the product involving the new scope of use needs to be submitted Indoor safety test report for current test crops; ③ For compound preparations, it is necessary to submit a description of the purpose of mixing and an indoor formula screening report.
The above-mentioned ①②③ materials need to be submitted in the field effect test application stage, and only need to be submitted in the formal registration application Copy
.
Field effect test reports shall be provided in accordance with: (a) Pesticides and fungicides shall be provided in 4 or more provincial administrative regions within the territory of China for field plot efficacy test reports for more than 2 years; (b) Herbicides and plant growth regulators shall be provided In the field of 5 or more provincial administrative regions in China, the efficacy test report of the field community for more than 2 years, for long-residual herbicides, the safety test report for the main subsequent crops should also be provided; (c) planted in some areas Crops (such as flax, sugar beet, oil sunflower, ginseng, rubber tree, lychee tree, longan tree, banana, mango tree, etc.
) or diseases, insects, and weeds that occur in local areas, can provide more than 3 provincial administrative regions, Field community efficacy test report for more than 2 years; (d) For some special agents, such as biocidal herbicides, we can provide field community efficacy test reports for more than 3 provincial administrative regions and more than 2 years; (e) For pesticides used in places with relatively stable environmental conditions, such as pesticides for storage, antiseptic, and fresh-keeping, we can provide efficacy test reports in more than 2 provincial administrative regions in China with more than 2 test cycles
.
The residual test data that needs to be submitted in the small optimization registration category of the dosage form need to distinguish whether the active ingredient has passed the protection period of the new pesticide or the protection period of the official registration
.
The environmental impact test data is consistent with the environmental data requirements of the new dosage form registration category
.
However, when the company has the required environmental data for the registered dosage form corresponding to the micro-optimization of the dosage form, it can provide environmental summary data
.
However, when the newly registered crops or usage methods of the pesticide formulation micro-optimization product, and the environmental impact data provided by the original formulation registration cannot meet the requirements of environmental safety assessment, the corresponding environmental impact data should be provided in accordance with the requirements of the new formulation
.
