Registration Process and Requirements for Pesticide Active Ingredients in China

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New Pesticides and Non-new Pesticides

In pesticide registration management in China, the registration procedures and documentation requirements for the active ingredients of new pesticides and non-new pesticides are completely different.

New Pesticide Active Ingredients

New pesticide active ingredients refer to those that have been first registered in China and contain new compounds.

The key point is that the molecular structure of this chemical substance has never been registered as a pesticide in China. Such registration requires the strictest requirements, and complete safety and efficacy assessment materials need to be provided.

Non-new Pesticide Active Ingredients (Generic Pesticides)

Generic pesticides refer to those whose active ingredients have already been registered by other enterprises in China.

The purpose of such registration is to produce and sell generic products that are equivalent in technical indicators to the registered products. The registration process and documentation requirements are relatively simplified, with the core being to prove that the generic products are of equal quality to the approved original products.

Regulatory Basis

Regulation on Pesticide Administration

The fundamental law governing pesticide management in China.

Measures for the Administration of Pesticide Registration

It stipulates the specific procedures for registration applications, acceptance, approval, and changes.

Data Requirements for Pesticide Registration

The core technical guidance document for preparing registration materials clearly stipulates the standards and data requirements for each test.

Registration of Entities Qualifications

Pesticide manufacturing enterprises

Pesticide producers that have been legally established on the territory of China.

Companies export pesticides to China

Pesticide manufacturers or distributors from abroad.

Developers of new pesticides

Either institutions or individuals, but usually they need to apply jointly with the manufacturing enterprises.

Note: Overseas applicants must designate a qualified agency in China to handle the registration procedures on their behalf.

New Pesticide Active Ingredient Registration Process

Registration of a new pesticide is a systematic and scientific assessment process that is lengthy and costly.

1. Preparation and Testing Phase

Feasibility assessment

Evaluate the market potential, research and development costs, and the registration cycle.

Test plan design

Communicate with laboratories that comply with Chinese GLP requirements and design a test plan that meets regulatory requirements.

Comprehensive testing

This is the longest phase. Entrust a GLP laboratory to complete all product chemical, toxicology, environmental impact, efficacy, and residue tests and obtain qualified test reports.

2. Application and Acceptance Phase

Data organization and submission

Organize all test reports and application forms in the prescribed format into a booklet and submit the electronic version through the online government affairs platform of the Ministry of Agriculture and Rural Affairs, and submit the paper version to the administrative approval hall.

Formal review

The Ministry of Agriculture and Rural Affairs will review the completeness of the materials and whether the format meets the requirements within 5 working days. If not, the applicant will be informed of all the contents that need to be supplemented at once. If the materials are qualified, registration will officially be accepted.

3. Technical Review Phase

Initiate review

ICAMA initiates the technical review and distributes the materials to its internal professional review departments.

Parallel review by each professional department

Product chemistry department: Review the identification of the active ingredient, physical and chemical properties, analytical methods, and analysis of all batches of components.
Toxicology department: Review the complete toxicology reports to assess the health risks to humans.
Environmental department: Review the environmental behavior and ecological toxicology reports to assess the risks to the environment and non-target organisms.
Efficacy department & Residue department: Review the efficacy tests and crop residue tests to assess their effectiveness and food safety risks.

Sample testing and rechecking

ICAMA organizes the rechecking of the product's chemical full component analysis and residue analysis method validation.

Deficiency letters (if necessary)

If problems or insufficient data are identified during the review, ICAMA will issue a "Supplementary Materials Notice" to the applicant. The applicant must submit supplementary materials within the specified period (usually 6 months).

Inter-ministerial consultation

ICAMA will send the safety assessment conclusion to the NHC and the MEE for consultation.

4. Expert Review Phase

Pre-meeting review

ICAMA summarizes all technical review opinions and ministerial opinions.

National Pesticide Registration Review Committee Meeting

Regularly hold review meetings where experts from various fields conduct the final comprehensive review of the application and vote to form a review conclusion of "Recommendation for Approval", "Recommendation for Not Approval", or "Need to Submit Supplementary Materials for Reconsideration".

5. Approval and Issuance Phase

Approval of decision and announcement

The Ministry of Agriculture and Rural Affairs makes an approval decision based on the review conclusion and announces it on the official website for 30 days.

Issuance of a registration certificate

If there are no objections during the announcement period, the pesticide registration certificate will be officially issued.

Registration Process for Active Ingredients in Non-new Pesticides

1. Premise Conditions

The data protection period for the original products has expired.

The active ingredients in the new pesticide have a 6-year data protection period. After the protection period expires, applications can be made via the imitation path.

Data preparation

The key points to prepare are the product chemical data (especially the 5-batch full component analysis) and the six test reports of acute toxicology.

2. Core Review Stage

The process is similar to that of the new pesticide, but the focus of the technical review is equivalence assessment.

Equivalence assessment

The core review of the ICAMA product chemistry department is to compare the 5 batches of full component analysis reports submitted by the applicant with the standards of the original drug manufacturer.

Whether the purity of the active ingredient is within the specified range.
Whether the types and contents of related impurities are consistent with the original product or below the safety threshold.
Whether new impurities with toxicological significance have appeared.

Acute toxicity verification

The toxicology department only reviews the six acute toxicity tests to verify that the toxicity level is consistent with that of the original product.

3. Approval and Issuance

After equivalence is recognized, the subsequent processes (expert review, approval and issuance) are completed quickly. The entire cycle usually takes 6-12 months.

Our Services

Proregulations conducts continuous and in-depth research into China's pesticide management regulatory framework, closely monitoring the latest developments in the regulations. Relying on a professional compliance service system, we provide you with full-process support for the smooth and rapid entry of your products into the Chinese market.

Regulatory interpretation and training
Product registration strategy consultation
Product registration Path Planning
Gap analysis
Document preparation, pre-review and submission
Official communication and progress tracking
Domestic agent in China
Continuous compliance support

Proregulations is dedicated to assisting global customers in obtaining market access qualifications for Chinese pesticide active ingredients efficiently and securely, significantly reducing uncertainties in the registration process and minimizing the time and cost of investment for customers. If you are interested in our services, please contact us.

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