On 13 Sep. 2017, China MoA detailed new data requirements for pesticide registration. The supporting document was compiled under new pesticide regulation which was promulgated earlier this year. The required data consists of study reports, risk assessment reports, sample of product, impurity and analytical standard, product quality specification, testing methods, label and manual templates, material safety data sheet, summary report, statement on authenticity, cited reference and documentary evidence. Depending on the pesticide origin and application area, the main text divides pesticide into 4 types: chemical pesticide, biochemical pesticide, microbial pesticide, botanical pesticide, hygienic pesticide and the technical details are separately provided in the annexes.
Table of contents:
Main Text
ANNEX I - Table of Definition and Item & Description on Data Requirements for the Registration TC/TKs
ANNEX II - Table of Definition and Item & Description on Data Requirements for the Registration Formulated Product
ANNEX III - Table of Definition and Item & Description on Data Requirements for the Registration Hygienic Formulated Product
ANNEX IV - Table of Definition and Item & Description on Data Requirements for the Registration Formulated Rodenticide
ANNEX V - Table of Definition and Item & Description on Data Requirements for Registration Amendment
ANNEX VI - Data Requirement for the Registration of Minor Crop Use Purpose
ANNEX VII - Guideline for the Areal Distribution of Efficacy Trial Site
ANNEX VIII - Crop Grouping for Residue Study
ANNEX IX - Minimal Number of Trial Sites Required for Residue Study
ANNEX X - Criterion for Technical Equivalence Determination of Me-too Pesticide
ANNEX XI - Principles for the Nomenclature of Pesticide
ANNEX XII - Principles for Concentration Ranges of Active Ingredient(s)
ANNEX XIII - Tests of Physical and Chemical Properties and Quality Specification Required for Different Formulation Type
ANNEX XIV –Criterion for the Toxicological Classification of Pesticide Product
Reference Links
