China Revises Pesticide Registration Data Requirements: Three Key Changes Overseas Companies Need to Know

The revisions in this Draft for Comments can be summarised into three areas: the closure of the "me-too pesticide" pathway; encouragement of pesticide innovation alongside tighter quality requirements; and both increases and decreases in data requirements. If you have a new pesticide or a follow-on product, these three changes will affect your registration pathway and timeline.

The "me-too pesticide" pathway is closed: registration categories are redrawn around authorisation

This Draft for Comments shuts the door on product equivalence altogether: it deletes the two definitions of "me-too technical material" and "me-too formulation", and removes the Rules for the Determination of Identical Pesticides together with them. The classification criteria are replaced by two new variables — "six years since first registration" and "whether authorisation from the first registrant has been obtained". The specific changes in classification are set out in Table 1.

Table 1 Registration categories for technical material (technical concentrate) and formulations of chemical pesticides (current vs. Draft for Comments)

The Draft for Comments redraws the follow-on pathway around two questions: "has six years elapsed?" and "has authorisation been obtained?"

1. those who obtain authorisation within the protection period of a new pesticide may take the reduced tier (technical material Category B / formulation Category E);

2. once the new pesticide protection period expires, they may take the simplified tier (technical material Category C / formulation Category K or Category L, similar formulations);

3. those who have not obtained authorisation for the new pesticide and are unwilling to wait (they are still within the six-year protection period) must submit the full data package required of a new pesticide (Category A / Category D).

The key change in this revision concerns the period after the new pesticide protection period expires: under the current system, a formulation follow-on whose protection period had expired could apply on its own for an "me-too pesticide" determination in order to obtain data relief. This revision removes that me-too pathway, and follow-on eligibility is now classified by two formal criteria — "six years" plus "authorisation".

Note in particular that the Draft for Comments does not create a Category E for microbial pesticide formulations (chemical, biochemical and botanical pesticides all have a Category E), so the authorisation-based follow-on pathway for new microbial pesticides is closed by default.

Encouraging Pesticide Innovation, Tightening Quality Requirements

1. The New Pesticide Pathway: "Complete Authorisation + Higher Quality Requirements"

Article 1.8 requires that, where an application is made using authorised data, the technical material (technical concentrate) must obtain a complete data authorisation from the first registrant, and the formulation must obtain complete authorisations from both the first registrant of the technical material (technical concentrate) and the holder of the corresponding formulation registration; the production process route and quality control items and specifications of the technical material (technical concentrate) must be superior or identical to those in the authorised data; for formulations with the same active ingredient, content, formulation type and range of application, the quality control must not be lower than that in the authorised data; and for those that differ, data must be submitted as for a formulation of a new pesticide.

If you are preparing to obtain authorisation from the first registrant during the six-year protection period of a new pesticide, a technical material follow-on needs authorisation for the new pesticide's technical material, whereas a formulation follow-on must obtain two complete authorisations — one for the new pesticide's technical material and one for the new pesticide's formulation. The requirement that quality be "no less stringent than the authorised data" also makes the authorising party's quality level the floor for your product. Before you open any authorisation talks, therefore, you must verify the other party's quality control standards; and where a formulation registration authorisation is concerned, both authorisations — for the new pesticide's technical material and for the new pesticide's formulation are indispensable.

2. Higher Quality Requirements for Follow-on Technical Materials

Article 1.10 requires that, for a pesticide containing a new compound, an application for registration of a technical material (technical concentrate) filed six years after the date of first registration must satisfy two conditions: its active ingredient content must not be lower than the highest content among registered technical materials (technical concentrates), and it must hold the corresponding scope of production licence.

The first registrant should plan the technical material and the formulation in parallel, using high content and high specifications to raise the industry benchmark. Follow-on applicants, once the six-year protection period for a new pesticide expires, must check in advance whether their content can reach the required level and whether they hold the corresponding scope of production licence.

3. Policy Design for Follow-on Formulation Products

Article 1.11 requires that, applications for registration of formulations of a new formulation type, new mixture formulations and formulations with a new content be accompanied by supporting materials demonstrating necessity, scientific soundness and reasonableness compared with already-registered products.

Article 1.12 requires that, for similar formulations, the registration trial may be filed for record only after the reference product has obtained registration.

For formulations involving a new formulation type, a new mixture or a new active-ingredient content, comparative justification materials must be prepared already at the project-planning stage. For similar formulation registration applications, the timing of trial filing is constrained by the registration progress of the reference product; in other words, a similar formulation is generally granted registration at least 2.5 years later than the reference product. This reflects a policy orientation that encourages formulation innovation, and it also raises the time cost of follow-on copying.

Data requirements adjusted both up and down: stricter for new pesticides, reduced for follow-on products

The Draft for Comments adjusts the testing items for each category according to the principle of "stricter for new pesticides, reduced for follow-on products": for new pesticides, professional requirements are moderately increased and optimised; for non-new pesticides, registration categories are adjusted and duplicate testing reduced.

On the stricter side: the technical material of a new pesticide (Category A) gains an independent "residue" section; plant and animal metabolism studies are moved from the formulation to the technical material, with their requirements raised; and toxicity data on major metabolites/degradates are considerably expanded. On the relief side: Category B (authorisation obtained within the six-year protection period of a new pesticide) no longer requires an equivalence determination — a complete authorisation alone suffices, and both the data and the procedure are simplified accordingly; Category C (after the six-year protection period of a new pesticide), compared with the full data package required for a current non-me-too technical material registration, is reduced to "product chemistry + 3 acute toxicity studies", at the cost of two new thresholds: a minimum content and a production licence.

Data reductions for formulations are set differently according to the follow-on scenario: a formulation (Category E) for which authorisation was obtained within six years and which has the same active ingredient, content, formulation type and range of application needs only general data and product chemistry. A similar formulation (Category K) with the same range of application and method of application needs only general data and product chemistry, whereas a similar formulation (Category L) differing in range of application or method of application additionally needs efficacy and residue data; both categories are exempt from human health and ecotoxicology data. A new-content formulation (Category G) with the same use pattern (registered crop, application rate, application timing, number of applications, etc.) may be exempt from residue data; a new formulation type (Category F) that does not involve a new range of application or a new method of application has its efficacy and residue trial points halved; and a new range of application (Category I) or a new method of application (Category J) removes the basic environmental test. The common boundary is that environmental risk assessment reports in general still be provided.

Fully taking account of new industry needs: three changes

First, public health pesticides are now subdivided into three categories — household hygiene insecticides, environmental hygiene insecticides, and the newly added "household gardening pesticides". Note in particular that technical material (technical concentrate) used only for processing repellents and indoor public health pesticides must not be used to process household gardening pesticides.

Second, a definition of "designated adjuvant" is added, and registration trial data generated with the pesticide sample to which the adjuvant has been added must be submitted.

Third, a new application scenario for "plant protection UAV spraying" is added, fully taking account of practical developments.

Recommendations for overseas companies

First, re-assess the category and pathway of projects under development. With the "me-too pesticide" pathway gone, follow-on products must be repositioned under the categories of new pesticide, similar formulation, new formulation type / new content / new mixture, or Category E authorised formulation, and time should be reserved for preparing the necessity, scientific soundness and reasonableness justification according to the registration category.

Second, companies holding the first registration certificate for a new compound should make full use of the six-year data protection window and plan around a combined strategy of filing the technical material and the formulation in parallel. As an authorising party, be mindful of how Article 1.8 constrains quality: the authorised product must be "no less stringent than the authorised data". The first registrant of a new pesticide can also invoke Article 1.10 to set a manufacturing-process threshold and raise the industry benchmark.

Third, for Category C technical material registration, an overseas company can both enjoy a substantial reduction in data requirements and be exempt from the requirement to hold the corresponding pesticide production licence in China.

Fourth, conduct a pre-project compliance review for formulations. The registration status of the reference product (for similar formulations, the registration trial may be filed for record only after the reference product has obtained registration), the content ceiling of registered products (after the protection period expires the content must not be lower than the highest registered content), and the boundaries of the three categories of public health pesticides (in particular the restriction on the source of technical material for household gardening pesticides) should all be included in the project-initiation checklist.

Fifth, manage the transition period. This document remains a Draft for Comments, and the final text will be subject to the officially published version; it is advisable to continue monitoring subsequent MARA announcements and to assess the risk of supplementation being required for applications currently in progress under the new requirements.

Conclusion

The data lists are being reduced while the market-order rules are being tightened — filing is more convenient, but data protection and content thresholds are higher. For overseas companies seriously positioning themselves in the Chinese market, the rules are more transparent and more predictable. It is advisable to recalibrate registration strategies against the Draft for Comments as early as possible and to respond as soon as the official version is published.

Note: This article is based on the Draft for Comments on the Data Requirements for Pesticide Registration released by MARA on 31 July 2026 and on the current Announcement No. 2569, and is subject to the officially published version.

Recommended Reading

• From Completeness to Scientific Rigor: Ecotoxicology in China's New Pesticide Registration

• A Comprehensive Guide to Authorizing Pesticide Registration Data in China

• Comparing China's 2025 and 2017 Measures for the Administration of Pesticide Registration