The demonstration trials are redefined as large area trials. Benefit analysis will be additionally required for pesticide registration. China’s new pesticide registration data requirements are significantly increased in terms of their technical requirements.
On 29 Dec 2017, China ICAMA opened a 60-day consultation on the” Pesticide guidelines for large area field efficacy trials”. China implemented new registration data requirements on 1 Nov 2017 in which a 1-year large area efficacy trial conducted in 2 different administrative regions will be required for registration of new agricultural and environmental use pesticides of chemical, biochemical, microbial and botanical origin.
The draft provides the procedures and general requirements on trial site selection, planting condition, minimum number of doses, area arrangement and acreage for different crop types, numbers of samples, principles on parameter recording and indicator selection. The detailed evaluation criteria for effectiveness against different pests on different crops/sites are specified in the national standard series GB/T 17980 and agricultural standard series NYT 1464.
Prior to the reform of China’s pesticide regulation, plot trial and demonstrative trial report were required for temporary registration and full registration. As temporary registration has been removed from the system, both type of trials are required for registration of new pesticide and demonstration trials are redefined as large area trial. Furthermore, benefit analysis on the proposed product will be additionally required. Benefit analysis requires applicants to evaluate pesticide compatibility with current agricultural practices and estimate the influence on the incomes of growers and conclude the possibility of substitution for higher risk pesticides.
Compared with the previous regulation, the new data requirements include significant adjustments and significantly increase compliance demands. Remarkably, updated data waiving conditions for differently registration types are specified in the Annex I to Annex IV, which provide 16 comparative tables of definition and instruction on the requirements for different product categories. At a glance the applicants can understand the tests and data required for different registration conditions such as new active ingredient, use scope, target pest, me-too product and chemically similar product etc.
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