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

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

TECHNICAL GRADE ACTIVE INGREDIENT(TGAI)

Applicable Scope

Currently, technical equivalence determination is mainly utilized for me-too registration, which enjoys considerable data waive and fast-track preference. In the draft, 3 more conditions were added.

Conditions subject to mandatory determination:

  • Apply for TGAI(technical grade active ingredient)registration under equivalent product(me-too) category;
  • A TGAI registrant alters the production process/production site;
  • If a formulation alters the source of TGAI, the equivalence determination between new sourced TGAI and the original TGAI should be conducted;
  • If an applicant is seeking registration under equivalent formulation, the equivalence between the TGAIs of the proposed formulation and referenced formulation should prior determined;

Tiers and Technical Criteria

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