Four major aspects associated with efficacy data requirements have been clearly defined in the new regulation: comparative analysis with existing pesticide, resistance management, efficacy validation test by subsequent applicant and necessary data to justify the scientificness of multiple compound pesticides.
Recently, China ICAMA hosted a panel discussion on the amendment of the “Data Requirement on Pesticide Registration”, which is an integral part of China’s new pesticide regulation. The discussion focused on efficacy data requirements which are divided into four major elements.
The amendment is designed to address the current industry situation where identical products are registered by multiple companies which lead to unnecessary wastage of resources and taxes administrative capacities unnecessarily.
Comparative analysis with existing pesticides requires use of an existing registered pesticide and will be assessed based on the relative advantages or disadvantages of the prospective pesticide;
Resistance management-The applicant will be required to explain any resistance associated with the new product. For pesticides already registered, the subsequent applicant should submit the pesticide resistance survey report. The classification code which categorizes the pesticides mechanism of action must be labeled on all commercial pesticides to promote the alternate use of other pesticides;
Stringent efficacy requirement- For pesticide with new chemical composition, new crop/site, new target (a. k. a “three new product”), the applicant should submit the laboratory bioactivity test report, crop safety test and 2-years field trial. For registration alteration and registration of equivalent product which do not involve new usage, the applicant should conduct the efficacy validation test within one year at multiple sites
Rationality of compound formulation-The applicant should explain the reasons for the compound formulation and present necessary data to justify the scientificness, necessity and rationality of the combination of active ingredient;
