A Comprehensive Guide: Registration of Identical and Non-Identical Active Ingredients (Technical Grades) in China

In China, there are two types of registration for active ingredients (technical-grade materials) of pesticides: “non‑identical active ingredient registration” and “identical active ingredient registration.” Although the difference is only one character, the registration costs and timelines vary significantly. Consequently, how to effectively leverage these two registration categories has become a key concern for many companies. In what follows, this article will provide a detailed explanation.

New Pesticide Registration
 

To clarify the concepts of “registration for a non‑identical active ingredient (parent compound)” and “registration for an identical active ingredient (parent compound),” we must first begin with “new pesticide registration.”

According to the “Requirements for Pesticide Registration Data,” the registration of technical-grade (parent) active ingredients for chemical and biochemical pesticides is categorized into new‑pesticide registration, non‑identical‑technical‑grade registration, and identical‑technical‑grade registration.

New pesticide registration refers to pesticides whose active ingredients have not yet been approved for registration in China, including both new technical-grade (parent) compounds and new formulated products. New pesticide registrations are granted a six-year period of protection.

During the six-year protection period, other enterprises must either conduct pesticide registration trials and submit applications in accordance with the new pesticide registration requirements, or obtain authorization to use the complete set of registration dossiers from an enterprise that has obtained registration for a new active ingredient (technical grade) under the new regulations.

After the six-year protection period, enterprises may either seek registration for a non‑identical active ingredient (parent compound) or conduct their own registration studies to obtain registration for an identical active ingredient (parent compound).

Note: The “same active ingredient (parent compound) registration” referred to below pertains to the self‑initiated submission of registration trials; it does not include registrations of the same active ingredient (parent compound) that are authorized under the full set of data requirements during the new pesticide protection period.

How to conduct tests on non‑identical and identical active ingredients (parent compounds)

Choosing the registration type?

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First, it is important to note that, compared with the registration of a different active ingredient (parent compound), registration of the same active ingredient (parent compound) entails fewer data requirements, lower costs, and a relatively shorter approval timeline. Therefore, if an application for registration of the same active ingredient (parent compound) is feasible, companies will invariably opt for this route. The specific circumstances are as follows:

Regarding document requirements

Registration of the same active ingredient (parent compound) requires submission of product chemistry data, including full‑component analysis, physicochemical properties, product quality specifications, and manufacturing process information. With respect to toxicology, the following six acute toxicity studies must be provided: acute oral, dermal, and inhalation toxicity tests; eye irritation test; skin irritation test; skin sensitization test; and the Salmonella/mutation assay. Additional toxicological data may be required as needed.

With regard to environmental impact, five ecotoxicity tests must be provided: the acute oral toxicity test for birds, the acute toxicity test for fish, the acute immobilization test for Daphnia magna, the acute contact toxicity test for honeybees, and the acute toxicity test for silkworms.

In general, registration of a non‑identical active ingredient (parent compound) requires the submission of additional data, such as 90‑day oral toxicity studies, four mutagenicity assays, and advanced toxicological tests.

In terms of registration costs and timelines

Because registration for the same active ingredient (parent compound) entails fewer data requirements, the associated fees typically amount to several hundred thousand yuan. In contrast, registration for a different active ingredient (parent compound) can range from around one million yuan at the low end to as much as ten million yuan at the high end. Moreover, depending on the complexity of data preparation and the rigor of the review process, the registration timeline for the same active ingredient is approximately one year, whereas for a different active ingredient it generally takes two to four years.

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Secondly, although we have clearly recognized the advantages of registering the same active ingredient (parent compound) in terms of registration costs and timelines, it is important to note that such registration is subject to certain prerequisites. These are as follows:

Registration under the new policy

For the registration of an identical active ingredient (technical material), the reference active ingredient must be a technical material that has been registered in accordance with the new “Requirements for Pesticide Registration Data.” Therefore, only technical materials that have obtained registration under the new regulations may be used as reference technical materials for the registration of identical active ingredients.

Select the first variety registered with a 6-year protection period.

When selecting the same active ingredient (parent compound) variety, it is essential to choose a pesticide variety whose first registration has already exceeded the six-year protection period.

If the reference product is still within the six-year protection period for new pesticides, the applicant must submit a registration application for the active ingredient (technical grade) of the new pesticide, rather than independently conducting registration trials and filing a registration application for the same active ingredient in accordance with the standard requirements. Unless, at that time, the applicant can obtain authorization to use the complete set of registration dossiers submitted by an enterprise that has already obtained registration for the new active ingredient under the new‑pesticide registration data requirements.

Belongs to chemical pesticides and biochemical pesticides.

Only chemical pesticides and biochemical pesticides are eligible for registration of the same active ingredient (technical grade); microbial pesticides and plant‑derived pesticides do not have a registration category for the same active ingredient and therefore cannot be registered under that category.

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Furthermore, whether registration of the same active ingredient (parent compound) can be successfully obtained is also a matter of close attention. Registration of the same active ingredient (parent compound) means that, compared with an already registered active ingredient, the applicant’s product has an active‑ingredient content and other key quality specifications that are no lower than those of the registered product, and that any impurities it contains produce adverse effects that are essentially equivalent to or less than those of the registered product.

The review process for the identification of the same active ingredient is conducted in two phases:

The first stage is the verification of product chemical data.

The second phase involves the evaluation and validation of toxicological data and environmental impact data.

Only when the relevant conditions are met can the same active ingredient be granted approval. For details, please refer to Figure 1 below.

Figure 1: Review Principles for the Recognition of Identical Active Ingredient Information

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Finally, although applications for the same active ingredient (parent compound) offer numerous advantages in terms of registration strategy, when such an application cannot be submitted or is not approved, companies must proceed with registration in accordance with the requirements applicable to non‑identical active ingredients.

Source: Rui'ou Technology