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China's New Pesticide Regulation: Elevated Criteria for “Me-too” Pesticide Registration

On 30 Jun. 2017, China MoA invited public consultation on “Data Requirements for Pesticide Registration” and 5 other supporting rules for new pesticide regulation. The guideline for the determination of technical equivalence was included in the Annex 4 of the “Data Requirements for Pesticide Registration”. Compared with the currently enforceable requirements, “MoA Order 10-Data Requirement on Pesticide regulation (2008)”, the new requirements clearly specify the applicable scope and some of the new criteria have become as stringent as that of developed countries. All of this is expected to reduce new registration of generic pesticide 30% by 2020. A comparative analysis on the scope and criteria is provided to interpret the impacts on me-too pesticide registration.

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