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Plant protection products and a majority of biocidal products are regulated by Regulations on Pesticide Administration and shall be registered with the Institute for the Control of Agrochemicals of Ministry of Agriculture and Rural Affairs (ICAMA) in HO168娱乐在线网址 prior to their production, import or use. In this HO168娱乐在线网址, we will give you a step-by-step HO168娱乐在线网址 on HO168娱乐在线网址 HO168娱乐在线网址 in HO168娱乐在线网址.

Note: This article is part of Free Guide on Pesticide Regulation and Registration in HO168娱乐在线网址. You may contact [email protected] to get a free copy.

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In HO168娱乐在线网址, HO168娱乐在线网址s are classified into chemical HO168娱乐在线网址s, biochemical HO168娱乐在线网址s, microbial HO168娱乐在线网址s, botanical HO168娱乐在线网址s and public health HO168娱乐在线网址s. Depending on product type and form (TGAI or finished formulation), data requirements vary significantly.

In this step, it is also important to know whether your product is regarded as a new HO168娱乐在线网址 or not (whether it has been registered in HO168娱乐在线网址 before). For new HO168娱乐在线网址, TGAI and formulation must be registered together (but not necessarily by the same applicant). For non-new-HO168娱乐在线网址s, you can choose to register TGAI or finished formulation separately.

Companies who export TGAI or finished HO168娱乐在线网址 formulation to HO168娱乐在线网址 can also apply for HO168娱乐在线网址 HO168娱乐在线网址 and become HO168娱乐在线网址 HO168娱乐在线网址 holder. This is usually done with the assistance of a local reliable agent like CIRS Group.

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In this step, applicant shall identify detailed HO168娱乐在线网址 data requirements (product chemistry, toxicology, environment, residue and efficacy) and data gaps for specific HO168娱乐在线网址 HO168娱乐在线网址 type.

HO168娱乐在线网址 currently only accepts test data generated in overseas labs that have been accredited by the Ministry of Agricutlure and Rural Affairs (MARA) or generated in GLP labs in countries/regions that have signed Mutual Acceptance of Data (MAD) agreement with HO168娱乐在线网址. So far, HO168娱乐在线网址 has not signed the MAD with OECD which means that studies done in OECD GLP labs are not accepted in HO168娱乐在线网址 for HO168娱乐在线网址 HO168娱乐在线网址.

For new HO168娱乐在线网址 AI and formulation, almost all studies must be conducted in Chinese labs accredited by MARA.

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HO168娱乐在线网址 implements online filing and submission of HO168娱乐在线网址 HO168娱乐在线网址. For manufacturers applying for HO168娱乐在线网址 HO168娱乐在线网址 in HO168娱乐在线网址 for the first time, they need to submit company related info to apply for HO168娱乐在线网址 HO168娱乐在线网址 management platform account through the administrative service hall of the MARA. Manufacturers with existing accounts can ignore this step.

Step 4: Application of Chinese Common Name for New Active Ingredient

For the new active ingredient not listed in GB 4839-2009 “Chinese common names of HO168娱乐在线网址s”, it is necessary to apply for the Chinese common name of the new active ingredient from the National Technical Committee for HO168娱乐在线网址 standardization, and obtain the naming letter and accurate Chinese common name. It is also necessary to complete the application byadding new active ingredient name information on the government service platform of MARA.

For other HO168娱乐在线网址s already assigned with common Chinese names, please ignore this step.

Step 5: Prepare Samples and Seal Them in HO168娱乐在线网址

The applicant needs to prepare the finalized HO168娱乐在线网址 test samples of the products to be registered, and submit the test samples to the local provincial agricultural and rural affairs department for sample sealing. For an overseas enterprise applying for HO168娱乐在线网址 in HO168娱乐在线网址, the sample shall be sealed by the agricultural and rural affairs department at the provincial level where the domestic office is located. This step is to ensure the samples received by labs for testing have been recorded/examined by agriculture authorities before testing starts.

Step 6:  Filing of Registration Test Record

The HO168娱乐在线网址 HO168娱乐在线网址 test record shall be filed through the "HO168娱乐在线网址 Pesticide digital supervision and management platform" before the test. This step is to inform authorites where the HO168娱乐在线网址 studies will be carried out carried out, making it more difficult/challenging for companies to provide fake test reports.

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After the records of HO168娱乐在线网址 HO168娱乐在线网址 test have been filed, the applicant can arrange HO168娱乐在线网址 tests on HO168娱乐在线网址 technical material (technical concentration) and/or HO168娱乐在线网址 formulation in institutes accredited by MARA, and carry out product chemistry, toxicology, efficacy, residue, environmental impact and other tests in accordance with the "Data requirements for HO168娱乐在线网址 HO168娱乐在线网址.

Step 8: Application for Registration

After the HO168娱乐在线网址 HO168娱乐在线网址 tests have been completed, the applicant shall complete the dossier (including required risk assessment reports) according to the "Data requirements for HO168娱乐在线网址 HO168娱乐在线网址” published in 2017.

Domestic HO168娱乐在线网址 production enterprises and new HO168娱乐在线网址 developers apply to the local provincial agricultural and rural authorities, and enterprises exporting HO168娱乐在线网址s to HO168娱乐在线网址 apply to the Ministry of Agriculture and Rural Affairs in Beijing. If the applicant is an enterprise exporting HO168娱乐在线网址s to HO168娱乐在线网址, it shall also submit supporting materials that the product has been registered in relevant countries (regions).

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The picture below shows you the diagram of evaluation and approval process, which typically takes about 6 months to 1 year.

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The total costs of HO168娱乐在线网址 HO168娱乐在线网址 consist of testing fee and consultancy fee, among which testing fee accounts for a large proportion. ICAMA does not charge administrative fees for HO168娱乐在线网址 HO168娱乐在线网址 applications. It takes about 4-5 years (including test time) to register a new chemical HO168娱乐在线网址 TGAI, 2-3 years to register a new bioHO168娱乐在线网址 or a new formulation or label extension in HO168娱乐在线网址.

Estimated testing fee for various types of HO168娱乐在线网址 is listed as below assuming all studies are carried out in Chinese GLP labs.

More Info

• State Council Decree 677 - Regulations on the Management of Pesticides in HO168娱乐在线网址

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The agrochemical division of CIRS group is located in Beijing. All team members have master's degree or above. The core members of this team are senior regulatory experts and risk assessment technical experts that have worked in top mult-national agrochemical companies for many years. We can help you remove your regulatory challenges and ensure smooth HO168娱乐在线网址 product HO168娱乐在线网址s in HO168娱乐在线网址.

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