What issues should be considered when registering a new pesticide?

Release Date:

2019-01-12

Announcement No. 2569 of the Ministry of Agriculture and Rural Affairs, “Requirements for Pesticide Registration Data,” sets forth provisions regarding new pesticides. A new pesticide refers to a pesticide whose active ingredient has not yet been approved for registration in China, encompassing both new technical-grade (parent) materials and new formulated products. The key criterion in this definition is that the active ingredient has not been approved for registration in China; even if a pesticide previously obtained temporary registration in China but never secured a valid product‑registration status, it will still be classified as a new pesticide once it obtains formal registration again. Furthermore, all new pesticide registrations are granted a six‑year period of protection. However, the following five categories do not qualify as new pesticides: new formulation types, new concentration formulations, new mixed‑formulation products, new intended uses, and new application methods.

　　Announcement No. 2569 of the Ministry of Agriculture and Rural Affairs “ Pesticide In the “Requirements for Registration Information,” it states regarding new… Pesticide It has been stipulated. New Pesticide It refers to products whose active ingredients have not yet been approved for registration in China. Pesticide , including new Pesticide Active ingredient (technical grade) and new Pesticide Formulation.
　　In the definition, “the active ingredient has not yet been approved for registration in China” Pesticide “is the key; previously granted temporary registration in China, but without a valid product registration.” Pesticide , after regaining formal registration, it is also considered new Pesticide ; new Pesticide All registrations are granted a six-year term of protection; none of these five “new” items qualify as new. Pesticide : New dosage forms, new strengths, new combination formulations, new indications, and new methods of use.
　　Apply for new Pesticide For registration, applicants shall submit 2 grams of the active‑ingredient reference standard, 0.5 grams of reference standards for the major metabolites and related impurities, 100 grams (or milliliters) of the technical‑grade (parent) material, and a 250‑milliliter sample of the formulated product.