MoA will accept the study report on product chemistry and toxicity obtained by overseas GLP-compliant laboratories from a country which has mutual or multilateral agreement on data acceptance with China. While the study on efficacy, residue and environmental impact must be carried out in China.
The draft of supporting rules will also accelerate the new establishment of more national MRLs (Maximum Residue Limits) and facilitate China’s contribution to the formation of international residue standards. If a pesticide was firstly registered on a crop, a suggestive MRLs should be proposed after its dietary risk assessment. For active ingredients and crops which China has already established MRL, a validation study will sufficient. If the established MRL was based on residue data which was generated outside China, the applicant will be required to conduct the study in China.
