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Official Registration of Pesticides

DATE:2010-08-04       SOURCE:MOA
 

Date: 07-26-2010

Source:MOA

 

Project Name: Official Registration of Pesticides

Project Category: Approval after Examination

 

Approval Content:

1. Whether confirm to the provisions of relevant regulations and policies of the state

2. Whether the product is effective or its quality is controllable, it is safe to human, animal, environment and other creatures.

3. Whether the application information and data is authentic, conform to relevant test standard requirement

4. The applicant qualifications

 

Legal Bases:

1. Administrative Regulations of the People's Republic of China on Pesticides

2. Methods for the Implementation of Administrative Regulations of the People's Republic of China on Pesticides (Promulgated by the No. 20 Order of Agriculture Ministry in 1999, modified by the No. 18 Order of Agriculture Ministry in 2002, by the No. 38 Order of Agriculture Ministry in 2004, by the No. 9 Order of Agriculture Ministry in 2007 )

3. Data Requirement of Pesticide Registration (Promulgated by the No. 10 Order of Agriculture Ministry in 2007)

 

Business Conditions:

1. Domestic applicant shall submit the opinions signed by the provincial pesticide certification institutions.

2. Shall submit the following materials in two copies with completely uniform content. One copy shall be original; the other shall be the duplicate. (But possess 6 copies of application forms and product abstract information). The duplicate materials on product chemistry, toxicology, potency, residue, environment influence, package and label and so on these materials shall be bound in different volumes with application form, product abstract material. The electronic text of application forms, product abstract information and product safety data sheet shall be provided. While applying for official registration for certain product directly, the applicant shall provide relevant materials regulated in the temporary registration phrase and official registration phrase at the same time. If the test and test and inspection information have been provided in the temporary registration phrase, while official registration being applied for new pesticide, the duplicates of these information shall be provided; While applying for official registration of other categories, in the case of making written statement, the applicant shall not provide.

⑴ Application Form of Official Registration of Pesticides

⑵ The following materials shall be provided for new pesticides:

Parent drug:

A. Product abstract information (Brief descriptions of origin, product chemistry, toxicology, environment influence, foreign registration status and so on)

B. Product chemical information (effective ingredient, parent drug).

C. Toxicology information

D. Environment influence information

E. Label or attached instructions

F. Product safety data sheet (MSDS)

G. Other materials: The toxicology, environment influence, registration information or comprehensive inquiry report and so on possessed by other countries or areas.

Pharmaceutics:

A. Product abstract information (Brief descriptions of origin, product chemistry, toxicology, potency, residue, environment influence, foreign registration status and so on)

B. Product chemical information (Except for the product chemical information regulated by the temporary registration phrase, the applicant shall also provide atmospheric temperature storage stability report of more than 3 batches.).

C. Toxicology information

D. Potency information (The demonstration test report of more than two regions with different natural conditions, the comprehensive report of the temporary registered product usage status).

E. Residue information (The residue test report implemented in our country for more than two years)

F. Environment influence information

G. Label or attached instructions

H. Product safety data sheet (MSDS)

I. Other materials: The toxicology, potency, residue, environment influence test and registration information or comprehensive inquiry report and so on possessed by other countries or areas.

The following materials shall be provided for special new pesticide products:

. Patent dug of public health pesticide (rodenticide, biochemical pesticide, botanical pesticide):

A. Product abstract information (Brief descriptions of origin, product chemistry, toxicology, environment influence, foreign registration status and so on)

B. Product chemical information (effective ingredient, parent drug).

C. Toxicology information

D. Environment influence information

E. Label or attached instructions

F. Product safety data sheet (MSDS)

G. Other materials: The toxicology, environment influence test, registration information or comprehensive inquiry report and so on possessed by other countries or areas.

Pharmaceutics of public health pesticide

A. Product abstract information (Brief descriptions of origin, product chemistry, toxicology, potency, residue, environment influence, foreign registration status and so on)

B. Product chemical information (Except for the product chemical information regulated by the temporary registration phrase, the applicant shall also provide atmospheric temperature storage stability report of more than 3 batches.)

C. Toxicology information

D. Potency information: as including the demonstration test report (Pharmaceutics for external environment purpose) of more than two regions with different natural conditions, the comprehensive report of the temporary registered product usage status.

E. Environment influence information

F. Label or attached instructions

G. Product safety data sheet (MSDS)

H. Other materials: The toxicology, potency, residue, environment influence, registration information or comprehensive inquiry report and so on possessed by other countries or areas.

Rodenticide pharmaceutics:

A. Product abstract information (Brief descriptions of origin, product chemistry, toxicology, potency, residue, environment influence, foreign registration status and so on)

B. Product chemical information (Except for the product chemical information regulated by the temporary registration phrase, the applicant shall also provide atmospheric temperature storage stability report of more than 3 batches.).

C. Toxicology information

D. Potency information: as including the demonstration test report (For the rodenticide used for farmland, forest and grassland) of more than two regions with different natural conditions, the comprehensive report of the temporary registered product usage status. 

E. Residue information (For the rodenticide applied roundly)

F. Environment influence information

G. Label or attached instructions

H. Product safety data sheet (MSDS)

I. Other materials: The toxicology, potency, residue, environment influence test, registration information or comprehensive inquiry report and so on possessed by other countries or areas.

. Biochemical pesticide pharmaceutics:

A. Product abstract information (Brief descriptions of origin, product chemistry, toxicology, potency, residue, environment influence, foreign registration status and so on)

B. Product chemical information (Except for the product chemical information regulated by the temporary registration phrase, the applicant shall also provide atmospheric temperature storage stability report of more than 3 batches.).

C. Toxicology information

D. Potency information: the demonstration test report of more than two regions with different natural conditions, the comprehensive report of the temporary registered product usage status.

E. Residue information (Provide in accordance with the characteristics and usage method of pesticides and upon the opinions of the Review Committee)

F. Environment influence information (The silkworm acute toxicity test report shall be provided. For the pesticides producing special risk to the environment, they shall provide the supplemental information on environment influence)

G. Label or attached instructions

H. Product safety data sheet (MSDS)

I. Other materials: The toxicology, potency, residue, environment influence test, registration information or comprehensive inquiry report and so on possessed by other countries or areas.

Parent drug of microbial pesticides:

A. Product abstract information (Brief descriptions of origin, product chemical and biological characteristics, toxicology, environment influence, foreign registration status and so on)

B. Information of product chemical and biological characteristics (effective ingredient, parent drug).

C. Toxicology information (The testimonial document of confirming that the effective ingredients aren’t known pathogens of human being or other mammals; basic toxicology information; supplementary toxicology information.)

D. Environment influence information

E. Label or attached instructions

F. Product safety data sheet (MSDS)

G. Other materials: The toxicology, environment influence test, registration information or comprehensive inquiry report possessed by other countries or areas; the release variation circumstance or its risk statement and so on in the environment.

Microbial pesticide pharmaceutics:

A. Product abstract information (Brief descriptions of origin, product chemical and biological characteristics, toxicology, potency, residue, environment influence, foreign registration status and so on)

B. Information of product chemical and biological characteristics (Except for the product chemical information regulated by the temporary registration phrase, the applicant shall also provide atmospheric temperature storage stability report of more than 3 batches.).

C. Toxicology information (The testimonial document of confirming that the effective ingredients aren’t known pathogens of human being or other mammals; basic toxicology information; )

D. Potency information: (The demonstration test report of more than two regions with different natural conditions, the comprehensive report of the temporary registered product usage status.)

E. Residue information (Provide in accordance with the characteristics and usage method of pesticides and upon the opinions of the Review Committee)

F. Environment influence information (birds acute oral toxicity test, fish acute toxicity test, bee acute oral toxicity test, bee acute contact toxicity test, silkworm acute toxicity test)

G. Label or attached instructions

H. Product safety data sheet (MSDS)

I. Other materials: The toxicology, potency, residue, environment influence test, registration information or comprehensive inquiry report possessed by other countries or areas; the release variation circumstance or its risk statement and so on in the environment.

Botanical pesticide pharmaceutics:

A. Product abstract information (Brief descriptions of origin, product chemistry, toxicology, potency, residue, environment influence, foreign registration status and so on)

B. Product chemical information (Except for the product chemical information regulated by the temporary registration phrase, the applicant shall also provide atmospheric temperature storage stability report of more than 3 batches.).

C. Toxicology information

D. Potency information: (The demonstration test report of more than two regions with different natural conditions, the comprehensive report of the temporary registered product usage status.)

E. Residue information

F. Environment influence information

G. Label or attached instructions

H. Product safety data sheet (MSDS)

I. Other materials: The toxicology, potency, residue, environment influence test, registration information or comprehensive inquiry report and so on possessed by other countries or areas;

The following information shall be provided for new formulations:

New formulations:

A. Product abstract information (Brief descriptions of origin, product chemistry, toxicology, potency, residue, environment influence, foreign registration status and so on)

B. Product chemical information (Except for the product chemical information regulated by the temporary registration phrase, the applicant shall also provide atmospheric temperature storage stability report of more than 3 batches.).

C. Toxicology information

D. Potency information: (The comprehensive report of the temporary registered product usage status.)

E. Residue information

F. Environment influence information

G. Label or attached instructions

H. Product safety data sheet (MSDS)

I. Other materials: The toxicology, potency, residue, environment influence test, registration information or comprehensive inquiry report and so on possessed by other countries or areas;

Minor optimization of pesticide formulations

A. Product abstract information (Brief descriptions of origin, product chemistry, toxicology, potency, residue, environment influence, foreign registration status and so on these information)

B. Product chemical information (Except for the product chemical information regulated by the temporary registration phrase, the applicant shall also provide atmospheric temperature storage stability report of more than 3 batches.)

C. Toxicology information

D. Potency information (The comprehensive report of the temporary registered product usage status.)

E. Residue information (If complying with one of the following conditions, in the case of providing residue test result abstract information of our country or relevant written statement, the residue information requirement can be exempted: A. The applicant already possessed residue information has formally obtained the registration of the same effective ingredient, formulation, usage scope and method for more than 6 years in our country, the application amount of effective ingredient of the product applying for formulation minor optimization is lower than 1.5 times of the application amount of its effective ingredient; B. If providing the authorization of the registered person possessing the product residue information with the same effective ingredient, formulation, usage scope and method independently, the application amount of effective ingredient of the product applying for formulation minor optimization is lower than 1.5 times of the application amount of its effective ingredient; )

F. Environment influence information

G. Label or attached instructions 

H. Product safety data sheet (MSDS)

I. Other materials: The toxicology, potency, residue, environment influence test, registration information or comprehensive inquiry report and so on possessed by other countries or areas;

New mixture pharmaceutics, new medical fertilizer mixture pharmaceutics

A. Product abstract information (Brief descriptions of origin, product chemistry, toxicology, potency, residue, environment influence, foreign registration status and so on these information)

B. Product chemical information (Except for the product chemical information regulated by the temporary registration phrase, the applicant shall also provide atmospheric temperature storage stability report of more than 3 batches.)

C. Toxicology information

D. Potency information (The comprehensive report of the temporary registered product usage status.)

E. Residue information (Provide the residue test report of provincial administrative regions with different natural conditions or farming systems in our country for more than two years. If the effective ingredient contained in the product complying with one of the following conditions, in the case of providing residue test result abstract information of our country or relevant written statement, the corresponding residue information requirement can be exempted: A. The applicant already possessed residue information has formally obtained the registration of the same effective ingredient, formulation, usage scope and method for more than 6 years in our country, the application amount of effective ingredient of the product applying for mixture pharmaceutics registration is lower than 1.5 times of the application amount of its effective ingredient; B. If providing the authorization of the registered person possessing the same effective ingredient, formulation, usage scope and method information independently, the application amount of effective ingredient of the product applying for mixture pharmaceutics registration is lower than 1.5 times of the application amount of its effective ingredient;)

F. Environment influence information

G. Label or attached instructions 

H. Product safety data sheet (MSDS)

I. Other materials: The toxicology, potency, residue, environment influence test, registration information or comprehensive inquiry report and so on possessed by other countries or areas;

. New content:

A. Product abstract information (Brief descriptions of origin, product chemistry, toxicology, potency, residue, environment influence, foreign registration status and so on these information)

B. Product chemical information (Except for the product chemical information regulated by the temporary registration phrase, the applicant shall also provide atmospheric temperature storage stability report of more than 3 batches.)

C. Toxicology information

D. Potency information (The comprehensive report of the temporary registered product usage status.)

E. Residue information (If complying with one of the following conditions, in the case of providing residue test result abstract information of our country or relevant written statement, the corresponding residue information requirement can be exempted: A. The applicant already possessed residue information has formally obtained the registration of the same effective ingredient, formulation, usage scope and method for more than 6 years in our country, the application amount of effective ingredient of the product applying for registration is lower than 1.5 times of the application amount of its effective ingredient; B. If providing the authorization of the registered person possessing the product residue information of the same effective ingredient, formulation, usage scope and method information independently, the application amount of effective ingredient of the product applying for registration is lower than 1.5 times of the application amount of its effective ingredient;

F. Environment influence information

G. Label or attached instructions 

H. Product safety data sheet (MSDS)

I. Other materials: The toxicology, potency, residue, environment influence test, registration information or comprehensive inquiry report and so on possessed by other countries or areas;

. New penetrant (or synergist) and pesticide mixture pharmaceutics

A. Common name, chemical name, structural formula, basic physicochemical properties, content, test method, source, safety, domestic and foreign usage condition and so on of relevant penetrant and synergist.

B. Indoor formula selection report of relevant penetrant and synergist.

C. While the applicants apply for the product registration as having the same effective ingredients, categories, content and formulation with the product of its own enterprise, but adding the product registration of penetrant or synergist, they may submit the information in accordance with new content registration, but submit the information in accordance with new formulation or new mixture pharmaceutics for other circumstances.

The following materials shall be submitted for the same pesticide products:

For the pesticide containing effective ingredients obtained the registration in our country and with the registered information being within protection period, they shall submit materials in accordance with the regulations of new pesticide registration information.

For the pesticide containing effective ingredients obtained the registration in our country and being beyond the registered information protection period and its parent drug having no obvious quality difference, they shall submit the following information:

A. Product abstract information (Brief descriptions of origin, product chemistry, toxicology, environment influence, and so on these information)

B. The confirmation and demonstration of the same parent drug with no obvious quality difference: the product name, enterprise name, pesticide registration number and comparative determination conclusion of the same parent drug having no obvious quality difference with the applied product, and relevant materials and so on used by the applicant for evidence purpose.

C. Product chemical information

D. Toxicology information

E. Environment influence information

F. Label or attached instructions 

G. Product safety data sheet (MSDS)

H. Other materials

.For the same pharmaceutics containing effective ingredients obtained the registration in our country and being beyond the registered information protection period and having no obvious quality difference, they shall submit the following information:

A. Product abstract information (Brief descriptions of origin, product chemistry, toxicology, residue, environment influence, foreign registration status and so on these information)

B. The confirmation and demonstration of the same pharmaceutics with no obvious quality difference: as including the product name, enterprise name, pesticide registration number and comparative determination conclusion of the same pharmaceutics having no obvious quality difference with the applied product, and relevant materials and so on used by the applicant for evidence purpose. 

C. Product chemical information

D. Toxicology information

E. Potency information

F. Residue information (If the same pesticide product after confirmation and registration has finished the residue test in our country, the application amount of the product applying for registration is lower than 1.5 times of the previous application amount, in the case of providing residue test result abstract information or relevant written statement of our country, the provision of residue test information can be exempted. If the same pesticide product after confirmation and registration has finished the residue test in our country, but the application amount of the product applying for registration is higher than 1.5 times of the previous application amount, the residue test report in our country for more than one year shall be provided. If the same pesticide product after confirmation and registration hasn’t finished the residue test in our country, the residue test report in our country for more than two years shall be provided. )

G.  Environment influence information

H.  Label or attached instructions

I.  Product safety data sheet (MSDS)

J.  Other materials

For the same pesticide product aside from the ,, items, its parent drug materials shall be submitted in accordance with the registration regulations of parent drugs of new pesticide or special new pesticide for parent drugs; For single-pharmaceutics, its materials shall be provided in accordance with the official registration regulations of new content pharmaceutics; For mixture pharmaceutics, its materials shall be provided in accordance with the official registration regulations of new mixture pharmaceutics. 

The following materials shall be submitted for the pesticide product with expanded usage scope and changed usage method and modified usage dosage:

. Expand usage scope:

A. Product abstract information (Brief description of potency, residue, environment influence, foreign registration status and so on these information)

B. Potency information (The comprehensive report of the temporary registered product usage status.)

C. Residue information (Being the same as the temporary registration residue information requirement of the registered pesticide varieties to which the products applied for registration belong.) 

D. Environment influence information (While adding the registered usage scope or usage method, the materials provided for previous pesticide registration product can’t meet the environment safety evaluation requirement, relevant environment influence test information shall be added. )

E. Label or attached instructions 

F. Other materials

Change usage method:

A. Product abstract information (Brief description of potency, residue, environment influence, foreign registration status and so on these information)

B. Potency information (The comprehensive report of the temporary registered product usage status.)

C. Residue information (Being the same as the temporary registration residue information requirement of the registered pesticide varieties to which the products applied for registration belong.)

D. Environment influence information (The change of usage method results in that the materials provided for previous pesticide registration product can’t meet the environment safety evaluation requirement, relevant environment influence test information shall be added. )

E. Label or attached instructions 

F. Other materials

Change usage dosage:

A. Product abstract information (Brief description of potency, residue, and so on these information)

B. Potency information (Field plot potency test report of more than one year)

C. Residue information (If the application amount is higher than 1.5 times of previous usage dosage, the residue test report of more than one year in our country shall be provided.)

D. Label or attached instructions

E. Others

 

Handling Procedures

1. Materials Acceptance. The comprehensive administrative examination and approval office of Agriculture Ministry shall accept the Application Form of Official Registration of Pesticide and other relevant materials submitted by the applicant (for foreign products) or provincial pesticide certification institutions (for domestic products), and implement preliminary examination.

2. Technology Examination. The Institution for the Control of Pesticides of Ministry of Agriculture shall implement the technology examination to the application materials in accordance with relevant regulations of the state.   

3. Expert Evaluation. For new pesticide and special new pesticide product, the national pesticide registration evaluation committee shall implement comprehensive evaluation to the application materials in accordance with relevant regulations of our state after the examination implemented and opinions proposed by the agriculture, chemicals, health, environmental protection departments of the State Council and National Supply and Marketing Cooperative General Agency.  

4. Handing Approval Document. The Department of Crop Farming Administration of Agriculture Ministry shall propose approval plan in accordance with the evaluation opinions, submit these for examination and approval of the Minster and handle the approval document.

 

Time Commitment: 10 business days (The term of technology examination and expert evaluation shall not exceed 12 months)

Fee Scale: 2500 Yuan/product (Change usage scope: 100Yuan/crop)

1. The Notice of Administrative Institutional Fees Items and Standards of Agriculture System of previous State Price Control Bureau and Finance Ministry ( Jia Fei [1992] No.452 )

2. The Notice of the State Planning Commission and Finance Ministry on Pesticide Registration Fees Standard Adjustment (Ji Jia Fei [1996] No.1718)

3. The Notice of the State Planning Commission and Finance Ministry on Uniting Domestic and Foreign Dual Fees Standards (Ji Price [2001] No.523)

 

Contact Information

Mail:  To: Pesticide Desk

Address: Administrative Examination and Approval Office

Ministry of Agriculture

No.11 Nongzhanguan Nanli, Chaoyang District, Beijing, China

Postcode: 100125  

 

(All information posted in this website is authentic in Chinese. English version is provided for reference only.)

 

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