37 Questions and Answers on Chemical Data for Pesticide Registration Products and Requirements for Testing Institutions

　　1. What changes have been made to the requirements for the full‑component analysis of the technical material?
　　A: There are five main changes. First, the number of sample batches for qualitative analysis has been reduced from five to one. Second, when performing quantitative analysis of impurities, the standard‑reference‑substance method must be used to determine the mass fractions of any impurity present at ≥0.1% and of related impurities present at <0.1%. Third, validation of quantitative analytical methods shall be conducted in accordance with the… Pesticide The “Guidance on Validation of Analytical Methods for Product Quality” requires the following: Fourth, reference standards must be accompanied by certificates of analysis, including the name, CAS registry number (where applicable), purity, source, batch number, expiration date, storage conditions, assigned values, and relevant spectra. For non‑commercial impurity reference standards, quantitation may be performed using the area normalization method, provided that qualitative identification is accurate. Fifth, the types of impurities that must be analyzed include anilines and substituted anilines; dimethyl sulfate derivatives; dichlorodiphenyltrichloroethane (DDT) compounds; ethylenethiourea (ETU) and propenethiourea (PTU) derivatives; halogenated dibenzo‑p‑dioxins; halogenated dibenzofurans; hydrazines and substituted hydrazines; nitrosamines; organophosphate oxide compounds; tetraethyl thiophosphates (e.g., monocrotophos); sulfoxides and sulfones of organophosphates and carbamates; chlorinated azobenzenes; methyl isocyanates; polychlorinated biphenyls (PCBs) and hexachlorobenzene (HCB); and phenols.
　　2. What are the main changes to the requirements for room-temperature storage stability testing?
　　A: There are three main changes. First, the number of test batches has been reduced from three to “at least one batch.” Second, the same product packaged in different materials must undergo separate room‑temperature storage stability studies. Third, products that have been determined to be identical formulations are not required to submit room‑temperature storage stability study data.
　　3. Does the active ingredient need to be labeled with a shelf-life, and is supporting data required? Can the shelf-life of the finished product be extended from 2 years to 3 years?
　　Answer: According to the Product Quality Law and the… Pesticide In accordance with the Regulations on the Administration of Labels and Package Inserts, active‑ingredient products must indicate a shelf life. The length of the shelf life shall be determined by the applicant based on the product’s stability. For registered formulated products, applications to extend the shelf life from two to three years will no longer be accepted or approved.
　　4. Can suspension seed coatings and aqueous formulations be re-approved for registration?
　　Answer: Due to the “…” issued in 2017, Pesticide The “Names and Codes of Formulations” (GB/T 19378) does not include suspension seed coatings and aqueous formulations. For registration applications submitted after October 31, 2017, product registrations for these two formulation types will no longer be approved. Applicants may, without altering the product’s composition, respectively change the formulation type of these two products to… seed The handling of suspension concentrates and soluble concentrates, as well as their quality control items and corresponding specifications, shall be adjusted accordingly. However, for registration applications received prior to October 31, 2017, product registrations for these two formulation types may continue to be approved.
　　5 Microorganisms Pesticide Is it necessary to submit data from low-temperature stability studies?
　　Answer: For microorganisms Pesticide For formulations, it is generally necessary to submit data from low-temperature stability studies; however, if the microbial strain is sensitive to low temperatures, the low-temperature stability study may be waived upon submission of supporting documentation.
　　6 If microorganisms Pesticide The manufacturing process for the formulation is an integrated one, encompassing fermentation, fermentation‑broth concentration, and the addition of excipients to produce the final finished product. Since no active pharmaceutical ingredient (API) is involved in this entire process, is it necessary to submit relevant documentation on the API?
　　Answer: Submission is required. According to the… Pesticide Annexes 2–3 on Microorganisms to the “Requirements for Registration Data” Pesticide In accordance with the requirements of Formulation Note ①, in the aforementioned circumstances, it is also necessary to submit a strain identification report for the active ingredient (or stock solution) prior to the addition of excipients, along with the strain designation, strain description, a complete manufacturing process, component analysis test reports, and stability study data (including sensitivity to temperature changes, light, and pH), as well as information on quality control items and their respective specifications.
　　7. If an applicant has simultaneously submitted applications for multiple test scopes, and one of those scopes encounters numerous issues during on-site inspection, will this affect the assessment and certification outcomes for the other test scopes?
　　Answer: According to the… Pesticide Article 3, Paragraph 3 of the “Rules for the Review of Registered Testing Entities” stipulates that if the scope of the requested tests encompasses multiple areas, separate sets of documentation shall be submitted. The Ministry of Agriculture and Rural Affairs shall review each application in accordance with its stated scope and issue a separate review outcome for each.
　　8   Pesticide In environmental testing during registration, potassium permanganate is used as the reference substance. Is it necessary to retain a sample of this reference material?
　　Answer: According to the… Pesticide Article 29 of the Measures for the Administration of Registration Trials stipulates that reference materials shall be retained and stored in accordance with the prescribed procedures. Pesticide In environmental testing, if potassium permanganate is used as a reference substance, samples shall also be retained and stored in accordance with the relevant regulations.
　　9 « Pesticide Article 37 of the “Good Clinical Practice for Registration Trials” stipulates that the final trial report shall include “filing information and new…” Pesticide “Registration trial approval certificate number” and other such details—does the “filing information” referred to here come from the applicant for the registration trial, or from the “trial institution”?
　　Answer: Pesticide The entity responsible for filing the registration trial is Pesticide The applicant for a registration trial shall provide the relevant filing information and ensure its authenticity.
　　10 « Pesticide Article 37 of the “Good Clinical Practice for Registration Trials” stipulates that the final trial report shall include, among other items, “documents certifying the qualifications of the trial institution (a copy of the institution’s certificate).” Pesticide Prior to the implementation of the Measures for the Administration of Registration Trials, the Ministry of Agriculture and Rural Affairs did not issue registration trial‑unit certificates to certain testing institutions listed in its announcements that complied with Good Laboratory Practice. How can these institutions ensure compliance with the aforementioned requirements when issuing test reports during the validity period of their qualifications?
　　Answer: With respect to the original announcement issued by the Ministry of Agriculture, Pesticide For testing institutions that have not been issued a certificate by the Ministry of Agriculture, a copy of the relevant public notice may be attached to the final test report as proof of the institution’s qualifications.
　　11 One experimental unit conducts concurrently Pesticide Registration trials and other non- Pesticide What are the key considerations for registration testing (such as feasibility studies)?
　　Answer: One trial site conducts concurrently Pesticide Registration trials and other non- Pesticide Registration tests (such as feasibility studies) shall be clearly identified and distinguished on the organizational chart and the site plan of the testing facility to prevent contamination and interference. Conduct… Pesticide When conducting registration trials, the requirements of “…” shall be met. Pesticide Requirements of the “Good Clinical Practice for Registration Trials.”
　　12 Which organizations are currently authorized to undertake the… Pesticide Some newly added test report items stipulated in the “Requirements for Registration Data” (such as plant metabolism studies, animal metabolism studies, and fish life-cycle tests)? Which entities are still undergoing accreditation, and which have not yet submitted applications to the Ministry of Agriculture and Rural Affairs? Can these meet the requirements for the second half of 2018? Pesticide Enterprise trial arrangements?
　　Answer: The Ministry of Agriculture and Rural Affairs will, upon the applicant’s request, organize an assessment of the application to undertake… Pesticide The institutions conducting registration trials shall undergo review, and those that pass the assessment and accreditation by the Ministry of Agriculture and Rural Affairs will have their names and trial scopes publicly announced by the Ministry in accordance with applicable laws and procedures. Applicants for registration may independently select a trial institution to carry out the relevant registration trials.
　　According to the… Pesticide Article 34 of the Measures for the Administration of Registration Trials stipulates that existing… Pesticide Test projects that the registered testing institution is unable to undertake shall be undertaken by an entity designated by the Ministry of Agriculture and Rural Affairs.
　　13. How are identical products, similar products, and products with a new content relative to this enterprise determined?
　　Answer: According to the… Pesticide According to the “Requirements for Registration Data,” when applying for registration of identical products, similar products, or products with a new content relative to this enterprise, the “reference product” must also be registered in accordance with the… Pesticide Registration Management Measures and Pesticide Requirements for Registration Documentation: Products that have obtained registration.
　　14   Pesticide What documents must be submitted for the transfer of registration information?
　　Answer: According to the… Pesticide The Regulations on Registration Management stipulate that the transferee, when applying… Pesticide At the time of registration, the parties shall submit the transfer contract, the transferor’s application for consent to cancel the registration certificate, and the original registration certificate to be cancelled, in accordance with the provisions of… Pesticide Registration materials as specified in the “Requirements for Registration Materials.”
　　15 How to understand “ Pesticide What is the meaning of “compliance with the registration document requirements” as set forth in Paragraph 1 and Paragraph 2 of Article 18 of the Regulations on Registration Administration?
　　Answer: “ Pesticide Article 18, paragraphs 1 and 2 of the “Administrative Measures for Registration” respectively provide for… Pesticide Provisions have been made regarding the authorization of registration data and the transfer of registration data. In this article, “compliance with registration data requirements” refers to compliance with the current registration data requirements, namely those set forth in the newly promulgated… Pesticide Requirements for Registration Information.
　　16 Is it possible to grant partial authorization? Pesticide Registration information?
　　Answer: No. According to the… Pesticide Article 18 of the Measures for Registration Management, Pesticide The holder of the registration certificate independently owns property that complies with the… Pesticide The complete registration dossier as specified in the “Requirements for Registration Dossiers” may be licensed for use by other applicants.
　　17 During the patent protection period Pesticide Can the product be registered?
　　Answer: An application may be filed. Upon objection or request by the patent holder, and in accordance with the provisions of the Administrative Licensing Law, the Ministry of Agriculture and Rural Affairs shall carry out the notification procedure.
　　18 Obtained Pesticide Can domestic enterprises that have obtained a product registration certificate but have not yet secured a production license (or a production approval certificate) continue to submit applications? Pesticide Registration?
　　Answer: According to the… Pesticide Regulations on Management》《 Pesticide The Measures for the Administration of Production Licenses stipulate that, for those who have obtained… Pesticide Domestic enterprises that have registered but have not obtained a production license (or a production approval certificate) shall not be approved for new additions. Pesticide Registration of products, amendment of registrations, and changes to enterprise names; those that have already been approved for registration. Pesticide Products may continue to apply for registration renewal prior to August 1, 2019. Enterprises that have not obtained a production license as of August 1, 2019, will have their registrations revoked. Pesticide Product registration certificate.
　　19 Can registration materials that have not been approved for registration be requested for return?
　　Answer: It can be retrieved. According to the… Pesticide “Requirements for Registration Dossiers”: Registration dossiers that have not been approved by the Ministry of Agriculture and Rural Affairs shall be retained for five years from the date of the decision to deny approval. Upon expiration of this period, applicants may apply to retrieve the dossiers within one year; those not retrieved shall be destroyed. If an applicant submits a new registration application within five years, a copy of the registration test report may be used.
　　20. Do changes in the types of fragrances used in sanitary insecticides require an application for registration amendment?
　　Answer: According to the… Pesticide According to the “Requirements for Registration Data,” the fragrance content in sanitary insecticides shall not exceed 1%; changes in the type of fragrance do not require a registration amendment.
　　21 How to proceed Pesticide Register the trial for recordal?
　　Answer: According to the… Pesticide Regulations on Management》《 Pesticide The Regulations on the Administration of Registration Trials stipulate that conducting… Pesticide For registered trials, the applicant shall file a record with the agricultural administrative department of the provincial people’s government where the trial is conducted; new… Pesticide Registration trials shall also be subject to review and approval by the Ministry of Agriculture and Rural Affairs.
　　22 According to Announcement No. 946 of the former Ministry of Agriculture, when used after dilution, Pesticide The product dilution ratio should be between 500 and 5,000 times; should this guideline still be followed?
　　Answer: The former Ministry of Agriculture Announcement No. 946 has been repealed. Pesticide The product dilution ratio is not subject to the aforementioned regulations, but it must ensure ease of use.
　　23   Pesticide How far in advance can an application for registration renewal be submitted?
　　Answer: Pesticide The registrant may apply for renewal of the registration up to six months (approximately 180 days) in advance.
　　24 The applicant has obtained Pesticide Can a product that has a production license but does not fall within the corresponding scope of production apply for registration renewal?
　　Answer: Yes. According to the… Pesticide “Requirements for Registration Documentation”: Applicants seeking to renew their registration shall submit a copy of their valid production license.
　　25. The stability test report under ambient conditions and the quality‑testing report, among others, have not yet been issued by a recognized registration‑test laboratory. How should these test data be prepared?
　　Answer: Prior to the publication of the list of registered testing institutions recognized by the Ministry of Agriculture and Rural Affairs, reports on room-temperature storage stability tests and quality‑testing reports may continue to be prepared in accordance with the previous requirements.
　　26 According to the original… Pesticide How is the number of residue test sites calculated for the two-year residue study data conducted under the “Regulations on Registration Data”?
　　Answer: According to the original… Pesticide According to the Regulations on Registration Data, for a two-year residue study conducted at a single location, the number of test sites shall be counted as two.
　　27   Pesticide Should the risk assessment report be prepared by a qualified entity?
　　Answer: Pesticide Risk assessment reports include health risk assessment reports, dietary risk assessment reports, and environmental risk assessment reports, which may be prepared by the registration applicant or by a relevant technical entity commissioned by the registration applicant.
　　28 Chemistry in the county-level chemical industrial park Pesticide Manufacturing enterprises may add new chemicals. Pesticide Is it active ingredient production?
　　According to the… Pesticide “Administrative Measures for Production Licensing,” the existing chemical… Pesticide Manufacturing enterprises may add new categories of formulation processing and production. To introduce the production of additional original drug varieties, the facility must be located within a chemical or industrial park at or above the city level.
　　29 New addition Pesticide Are there quantity restrictions for manufacturing enterprises? Is it sufficient as long as they comply with the… Pesticide If the conditions set forth in the Measures for the Administration of Production Licenses are met, enterprises may submit an application. Pesticide Production license?
　　《 Pesticide Regulations and Pesticide The Regulations on the Administration of Production Licenses stipulate that Pesticide The conditions for a production license do not impose any restrictions on approval. Pesticide The number of production licenses. Therefore, any enterprise that meets the eligibility criteria may submit an application. Pesticide Production license.
　　30 When applying for a master drug substance manufacturing license, how is this verified? Pesticide Registration status?
　　 Pesticide Registration is divided into two main categories: active ingredients (technical-grade materials) and formulated products. In general, applicants should apply for registration of the active ingredient; when applying for registration of the technical‑grade material, they must provide a justification for producing the technical‑grade material, primarily in cases where, due to technical or safety considerations, registration of the active ingredient is not feasible.
　　To prevent conflicts between the approval outcomes of provincial agricultural authorities regarding applications for active‑ingredient production licenses and the Ministry of Agriculture and Rural Affairs’ review opinions on active‑ingredient registration, … Pesticide Article 33 of the “Detailed Rules for the Examination of Production Licenses” (Ministry of Agriculture and Rural Affairs Announcement No. 2568) stipulates: “An application…” Pesticide For products manufactured as active pharmaceutical ingredients, verification of the said… is required. Pesticide Registration details.” Annex 1 to this announcement, “ Pesticide The “Sixth Section: Other Requirements” of the Production License Review Form (applicable to technical-grade or parent compounds) explicitly states, “For facilities whose production scope is limited to parent compounds, this…” Pesticide The parent drug should already have been approved by an enterprise in China. Pesticide Registration.” During the review and approval of production licenses, it shall be required to “inspect the…” Pesticide “Registration status of the parent compound,” that is, this Pesticide Whether the parent drug has already been registered by an applicant is not a limiting factor. Pesticide The applicant for a production license. However, the applying enterprise has not yet obtained this… Pesticide Prior to obtaining the registration certificate for the active ingredient, production of that active ingredient remains prohibited.
　　31 Previously obtained Pesticide Registered but not yet obtained Pesticide Production license certificate or Pesticide When should enterprises producing sanitary insecticides apply for a production license? Pesticide Production license?
　　According to the… Pesticide Article 30, Paragraph 3 of the Measures for the Administration of Production Licenses and… Pesticide Pursuant to Article 40, Paragraph 2 of the Registration Management Measures, it has been obtained. Pesticide Registered but not yet obtained Pesticide Production approval certificate or Pesticide Enterprises holding a production license may apply at any time. Pesticide Production license. However, since the… Pesticide Within two years from the date of implementation of the Measures for the Administration of Production Licenses, those who have still not obtained a license issued by the provincial agricultural administrative authority… Pesticide Within the territory of the People’s Republic of China for the production license Pesticide The holder of the registration certificate shall have their previously obtained registration revoked by the Ministry of Agriculture and Rural Affairs in accordance with the law. Pesticide Registration certificate.
　　32 Existing Pesticide The dosage form indicated on the registration certificate differs from that specified in the newly promulgated and implemented national standard “ Pesticide If there is a discrepancy between the formulation name and the code specified in “Formulation Name and Code” (GB/T 19378–2017), which formulation name shall the enterprise use when submitting its application? Pesticide Scope of the production license?
　　The newly promulgated and implemented national standard “ Pesticide “Names and Codes of Dosage Forms” (GB/T 19378–2017) has revised the names and codes of certain dosage forms; however, this standard is a recommended national standard. Existing… Pesticide If the dosage form indicated on the registration certificate is inconsistent with the relevant national standard, the enterprise may, based on the dosage form of the registered product, apply for the corresponding… Pesticide Scope of production.
　　33 If the dosage form for which a manufacturing license is being applied is listed in the… Pesticide Annex 3 of the “Detailed Rules for the Examination of Production Licenses” Pesticide The production scope specified in the “Requirements for Production Equipment” does not list it. How should the applicant submit the relevant documentation, and how will the review be conducted?
　　Applicants shall submit the relevant documentation and provide corresponding explanations based on actual production conditions, including the names of equipment used for the proposed dosage form and the key manufacturing processes. The production‑license review personnel shall conduct a scientific and rational assessment in light of the specific characteristics of the dosage form and the associated manufacturing processes.
　　34. Who is the applicant for filing a registration trial? Is it the testing institution, or...? Pesticide Applicant for registration?
　　According to the… Pesticide Article 2, Paragraph 2 of the Measures for the Administration of Registration Trials, to carry out Pesticide For registration trials, the applicant shall file a record with the provincial agricultural administrative authority where the trial is conducted. Pesticide The entity responsible for filing the registration trial is Pesticide Applicant for registration.
　　35 to Pesticide What are the requirements for registering test samples?
　　 Pesticide The primary purpose of registration is to evaluate the product’s efficacy and safety. The applicant shall ensure that, in future registration and production, the product’s composition, manufacturing processes, and other relevant aspects are consistent with those of the registered test sample. Therefore, Pesticide The samples submitted by the applicant shall meet the following requirements: (1) they must be products that have been thoroughly researched and finalized by the applicant; (2) their composition, identification methods, quality control criteria, and testing procedures must be clearly defined and have passed product quality inspections; (3) they must satisfy… Pesticide Register the sample requirements for all trials; (4) clearly specifies the product’s storage conditions, manufacturing date, and shelf life.
　　36 Why do we need to… Pesticide How is the registration test sample sealed and managed? How should the registration test sample be sealed?
　　 Pesticide The authenticity of the registered test sample is Pesticide The source of the reliability of registration test results. To ensure the authenticity of registration test samples and facilitate the identification of the root causes behind “problematic test reports,” it is essential to make scientifically sound and reasonable decisions. Pesticide Registration and approval decision, Pesticide Articles 22 and 23 of the Measures for the Administration of Registration Trials stipulate that… Pesticide Registered test samples shall be subject to sealed‑sample and retained‑sample management.
　　 Pesticide Before conducting registration trials, the applicant shall submit to the provincial agricultural authority of the locality… Pesticide Provided by the verification agency Pesticide Test samples and related sample information. Provincial level. Pesticide After the testing institution verifies the relevant information of the sample, it shall… Pesticide The sample shall be sealed, and one copy shall be retained.
　　 Pesticide The applicant for the registration trial shall deliver the sealed samples to the trial‑conducting institution for the relevant testing and shall also retain one copy. Pesticide When conducting registration trials, the registered testing institution shall also retain samples.
　　Carried out by agricultural authorities at or above the provincial level Pesticide Random inspections and testing of registered trial samples, for… Pesticide Inspection of registered testing institutions is conducted. For example, if a test sample fails to meet product quality standards, its test report shall not be used for… Pesticide Registration; for those who conduct trials in violation of the registration management regulations, the trial institution shall be ordered to make corrections within a specified time limit.
　　37 How do overseas enterprises apply for registration of clinical trials? Where can they complete the sealing and sample‑registration procedures?
　　According to the… Pesticide In accordance with Article 9 of the Regulations, registration trials conducted by overseas enterprises must also be filed with the provincial agricultural administrative authority where the trials are carried out. If it is a new… Pesticide Registration trial, in accordance with the… Pesticide In accordance with Article 17 of the Measures for the Administration of Registration Trials, conduct new… Pesticide For registration trials, foreign enterprises shall submit an application to the Ministry of Agriculture and Rural Affairs and provide the relevant documentation.
　　According to the… Pesticide Article 22 of the Measures for the Administration of Registration Trials stipulates that applicants who are foreign enterprises shall submit trial samples to the provincial-level authority at the location of their representative office established within China. Pesticide The verification body shall seal the samples.

Source: Wei Yu Pesticide