Report: Product planning and design before pesticide registration is a very important preparation work, of which the setting of content and dosage form are two items that should be paid particular attention to. While meeting the market demand, it should also meet the requirements of the registration policy, otherwise it will also affect the registration. Today, Xiaobian sorted out some matters that need to be paid attention to in the setting of content and dosage form for reference.
Content setting requirement
1, the effective composition and dosage form of the same single dose or the same proportion of mixed agents, its content shall not exceed 3 gradients; Separate classification of pesticides with low active ingredient content for direct use without dilution or dispersion.
(2) If the active ingredient content is specified by the national standard or the row standard, it should meet the requirements of the standard, and it should also meet the above three gradient requirements. If there is no national standard, line standard or no specific provisions in the standard document, the following details should be paid attention to:
Products with the same active ingredient and dosage form, products with an active ingredient content ≥10% (or 100 g/l), and the content change interval value is not less than 5% (or 50 g/L); For products with an active ingredient content < 10% (or 100 g/l), the content change interval is not less than 50% of the active ingredient content.
If the active ingredient content is "≥10% or 100 g/L", the significant number of the content is not more than 3 digits; If the active ingredient content is "< 10% or 100 g/L", the content significant number is not more than 2 digits. If the total content of the mixture and the content of each component cannot simultaneously meet the provisions of the significant number, the total content shall meet the requirements.
3, cream, microemulsion, wettable powder products, the active ingredient content shall not be lower than the approved registration products (including the same proportion of mixed products) of the active ingredient content.
4. The content of effective ingredients of sanitary insecticides should refer to the content range of effective ingredients of sanitary insecticides recommended by the World Health Organization or the content of registered products.
Dosage form setting requirements
1, pesticide dosage form name and code National standard document 2003 version of the dosage form, but the 2017 version does not, will no longer be approved;
2. Pay attention to whether the dosage form is consistent with the mechanism of action and physical and chemical properties of the active ingredient, such as whether the active ingredient is easily soluble in water but processed into a suspended agent, and whether the solubility in water is low but processed into a soluble granule, etc., the dosage form setting should be carefully considered to determine its rationality.
3, granules are generally suitable for the prevention and control of soil-borne diseases, underground pests, in addition to sugar cane and other special crops and their planting environment constraints, remember to eliminate through the soil application of the way to control above-ground diseases and pests granule product project registration.
4, some specific dosage forms also specify the production technical index requirements, different dosage forms in the production, toxicology, efficacy, environment, residue and other tests also have certain differences. Dosage form setting to a certain extent affects the production difficulty and cost, registration difficulty and cost, it is necessary for enterprises to make comprehensive consideration in advance.
The above are some matters that need to be paid attention to when the pesticide content and dosage form are set, and the preparation work is fully conducive to the smooth progress of the later registration work. At the same time, in view of the registration cycle is generally more than 2 years, during which there may be other enterprises publicized products and their own registration of product content, dosage forms, etc., are relatively close to the situation, resulting in non-compliance with policy requirements, which requires timely and appropriate changes
Precautions for setting pesticide registration content dosage form
2023 10/30