​Guideline for determining China pesticide registration types

Date:01-24-2024

When preparing for pesticide product registration, the first step is to confirm the registration type. The registration type selection directly affects the necessary data items, dossier submission, and evaluation criteria. Choosing the wrong registration type will slow down the registration process and even affect the entire registration project. Therefore, it is essential for applicants to clarify the registration type of their pesticide products and organize the required tests accordingly to ensure a smooth registration process.

What is the definition of ″new pesticide″?

New pesticide refers to pesticides that contain active ingredients that have not yet been approved for registration in China. It includes new pesticide technical materials (technical concentrate) and new pesticide formulations.

• New pesticide technical materials (technical concentrate): this includes pesticides that have been registered as pesticides but lack valid product registrations, as well as new pesticides within the 6-year protection period of new pesticide registration but have not obtained data authorization from the first applicant.

  
  

• New pesticide formulations: this includes formulations within the 6-year protection period which have not obtained authorization from the first applicant.

What is the definition of ″non-new pesticides″?

Non-new pesticide is a pesticide product that contains the same active ingredient as a registered active ingredient and has passed the new pesticide protection period. It is also classified as pesticide technical materials and pesticide formulations.

Registration of Technical Material (Technical Concentrate)

• Me-too Technical Material: this refers to a technical material whose active ingredient content and other main specifications are not lower than those of the reference source. The adverse effects caused by the contained impurities are essentially the same as or less than those of the registered reference source.

  
  

• Non-me-too Technical Material (technical concentrate): This category encompasses technical materials that are not considered me-too, based on specific criteria.

New Formulation Registrations

• New formulation types: this refers to formulations that contain active ingredients identical to those that have been registered, but the specific formulation type has not been registered.

  
  

• New concentration: this refers to formulations of which the active ingredients and formulation types are identical to those that have been registered but with an unregistered concentration (with unchanged formulation ratios for ready-mixtures).

  
  

• New mixtures: this refers to formulations of which the active ingredients and formulation types are identical to those that have been registered, but have different formulation ratios compared to previously registered mixtures with the same active ingredients. It can also refer to formulations that are the first mixture of two or more active ingredients.

  
  

• New application scope: this refers to formulations that contain active ingredients identical to those that have been registered, but the specific application scope has not been registered.

  
  

• New application method: this refers to formulations in which the active ingredients and scope of use are identical to those that have been registered, but the specific application methods have not been registered.

  
  

• Me-too formulation: this refers to a formulation being registered that, compared to the reference source, has the same active ingredient content, the same types and levels of other restrictive components, and the same formulation type as the registered product. The toxicity and environmental risks of the formulation do not significantly increase with the other adjuvants, the primary specifications are not lower than the registered product, and the technical materials used should be technical equivalent to the reference source. (The registration of the me-too formulation is further subdivided into the same application scope and application method, the different application scope and application method, and there are some differences in the data requirements.)

  
  

• Similar formulation: this refers to a formulation being registered that, compared to an already registered formulation, has the same active ingredient, content, and formulation type, but differs in other compositional components. (The registration of similar formulations is further subdivided into the same application scope and application method, the different application scope and application method, and here are some differences in the data requirements.)

In summary, when preparing to initiate a pesticide registration, you can retrieve information on relevant registered products containing the active ingredient through the China Pesticide Information Network (http://www.icama.org.cn/zwb/index) to determine the registration type of your product. Based on the type of pesticide registration, you can then prepare the dossier in accordance with the requirements outlined in the latest version of the Guidelines for Pesticide Registration Data. This will ensure that you follow the prescribed procedures and requirements for pesticide registration.