Auxiliary system, auxiliary device, auxiliary method, and program

Abstract

Improve the efficiency of advance preparation for preparing application documents for pesticide registration. [Solution] The assistance system is a system that assists in the preparation of application documents for pesticide registration, and has one or more processors. The processors accept information about the pesticide that is the subject of the application, and use a generation AI to present the necessary information needed to prepare the application documents for the pesticide based on the laws and regulations regarding the registration of the pesticide.

Description

[Technical Field]

[0001] The present invention relates to an auxiliary system, an auxiliary device, an auxiliary method, and a program for preparing application documents. [Background technology]

[0002] In countries around the world, the manufacture and sale of chemical products such as pesticides, pharmaceuticals, chemical substances, and cosmetics require approval and authorization from the appropriate administrative agency. For example, pesticides are regulated by the Agricultural Chemicals Control Act, and only those that meet certain standards after review are registered as pesticides. In other words, when applying for pesticide registration, application documents for the pesticide's registration must be submitted to the administrative agency that acts as the registration authority, along with documents detailing test results regarding the pesticide's safety, toxicity, residual properties, etc. (hereinafter referred to as "test reports"), and approval (registration) must be obtained after review.

[0003] The application documents for the registration of pesticides are summaries of the test reports in accordance with the format specified by the country or region (for example, in Japan, the regulations are called dossier guidance). The application documents for the registration of pesticides are generally called "dossiers" and must be prepared for each test report.

[0004] Additionally, the current process for preparing application documents for pesticide registration requires applicants to manually review and summarize the contents of the enormous number of test reports to be submitted, which is a laborious task that requires a considerable amount of time and effort, including checking the numerical values ​​of test results, determining compliance with guidelines, and checking for typos. Furthermore, while the period varies by country and region, in Japan, the preparation and submission of such application documents is mandatory every 15 years. Therefore, there is a need for more efficient advance preparation for preparing such application documents.

[0005] A system has been proposed that enables the creation of agricultural application forms required for certification applications for organic agricultural products, etc., in accordance with the variety and type of agricultural product (see, for example, Patent Document 1). However, this system does not streamline the advance preparation for creating application documents for the registration of pesticides. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] Japanese Patent Application Laid-Open No. 2009-271703 Summary of the Invention [Problem to be solved by the invention]

[0007] The present invention aims to improve the efficiency of advance preparations for preparing application documents for the registration of pesticides. [Means for solving the problem]

[0008] To this end, the present disclosure provides a system for assisting in the preparation of application documents for the registration of pesticides, the system having one or more processors, which accept information about the pesticide that is the subject of the application, and which uses a generation AI to present the necessary information required to prepare the application documents for the pesticide based on the laws and regulations regarding the registration of the pesticide. [Effects of the Invention]

[0009] According to the present invention, advance preparation for preparing application documents for the registration of agricultural chemicals can be made more efficient. [Brief explanation of the drawings]

[0010] [Figure 1] 1 is a diagram showing an outline of the configuration of an application document preparation support system according to an embodiment of the present invention; [Figure 2] 1 is a block diagram showing the hardware configuration of an application document preparation assisting device according to an embodiment of the present invention; [Figure 3] 1 is a block diagram illustrating an example of the configuration of an application document preparation assisting device that functions as a server in the present embodiment. [Figure 4] FIG. 10 is a sequence diagram showing an example of an application document preparation support process according to the present embodiment. [Figure 5] 1 is a flowchart illustrating an example of the basic operation of an application document generation preparation process in the application document generation assisting device according to the present embodiment. [Figure 6] FIG. 10 is a flowchart illustrating another operation of the application document generation preparation process according to the present embodiment. [Figure 7] 10 is an example of a necessary information display screen that displays necessary information according to the present embodiment. [Figure 8] 10 is an example of a necessity degree display according to the present embodiment. [Figure 9] 10 is an example of a result information display according to the present embodiment. [Figure 10] FIG. 10 is a flowchart illustrating another operation of the application document generation preparation process according to the present embodiment. [Figure 11] FIG. 10 is a flowchart illustrating another operation of the application document generation preparation process according to the present embodiment. [Figure 12] 10 is an example of an additional information suggestion screen according to the present embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0011] The embodiments described below are preferred examples of the present invention and are therefore subject to various technical limitations. However, the scope of the present invention is not limited to these embodiments unless otherwise specified in the following description.

[0012] However, when preparing and submitting application documents, it can sometimes be discovered that test results or other materials are missing, and in the current situation where this is handled manually, it is difficult to carry out advance preparations for pesticide registration applications efficiently and without waste. Furthermore, when registering the same pesticide at a review agency in a country or region other than Japan, differences in requirements between countries mean that it is necessary to check and prepare test results and documents for the pesticide registration application again, which is a hassle. Therefore, there is a need to streamline advance preparations for creating application documents that take into account registration at multiple review agencies.

[0013] In addition, submission of documents related to risk assessment is also required as part of the application documents. Risk assessment involves comprehensively assessing the results of various tests and calculating the expected effects. Specifically, risk assessment is based on the toxicity of the pesticide, which is the danger of the pesticide itself, and the amount of exposure related to intake by humans and other organisms. If this risk assessment determines that there is a risk, additional tests must be conducted to reduce the risk. Therefore, it is desirable to streamline the advance preparation of risk assessment documents in preparation for the creation of application documents.

[0014] As an example of this embodiment, we will explain below, with reference to drawings, how generation AI is used to present the information necessary for creating application documents for the registration of pesticides (hereinafter referred to as "dossier"), and to efficiently assist in the confirmation of test results and materials, etc., and in advance preparations, in order to increase the registrability of the pesticides.

[0015] (System Configuration) FIG. 1 is a diagram showing an outline of the configuration of an application document preparation support system according to this embodiment.

[0016] As shown in Figure 1, application document preparation support system 1 in this embodiment includes application document preparation support device 10 that receives information about the pesticide that is the subject of a registration application and presents the necessary information needed to prepare a dossier based on the laws and regulations (hereinafter referred to as "guidelines") related to the registration of that pesticide. Application document preparation support system 1 also includes applicant terminal 30 that provides information about the pesticide and receives the necessary information needed to generate a dossier, and administrator terminal 50 that manages this system 1 so that the necessary information needed to generate a dossier can be presented efficiently.

[0017] The application document preparation support device 10, the applicant terminal 30, and the administrator terminal 50 are connected to each other so that they can communicate with each other via a network N such as the Internet. In the following description, the application document preparation support system 1 may be referred to as the present system 1.

[0018] In other words, this system 1 is a system that assists in the creation of dossiers for pesticide registration, and has one or more processors.The processor is an auxiliary system that accepts information about the pesticide that is the subject of the application, and presents the necessary information needed to create the pesticide dossier using a generation AI based on guidelines for pesticide registration (an example of legislation).

[0019] Here, the generation AI used in this embodiment can use large-scale language models (LLMs). The generation AI is obtained by performing deep learning on a neural network. A prompt containing instructions is input to the generation AI, and inference data such as voice data indicating speech, text data indicating text, and image data indicating an image is also input. The generation AI performs inference on the input inference data in accordance with the instructions indicated by the prompt, and outputs the inference results in a data format such as voice data and text data. Here, inference can be, for example, analysis, classification, prediction, and / or summarization. In this embodiment, a prompt is input that specifically specifies the information desired to be obtained so that the information desired to be output (generated) by the generation AI is obtained. Furthermore, in this embodiment, the prompt also includes, depending on conditions, specification of information that will be used as material for generating the desired information.

[0020] The generation AI of this embodiment can also refer to organizational information limited to within an organization, such as a large amount of business documents and regulations accumulated in an organization such as a company. Furthermore, the generation AI of this embodiment can also refer to the latest information outside the organization that can be obtained via a network connected to the outside of the organization. The generation AI of this embodiment can generate information such as text based on organizational information while acquiring the latest information through information searches outside the organization.

[0021] The application document preparation support device 10 accepts information about pesticides from the applicant terminal 30 and presents the necessary information required to generate a dossier using the generation AI. It does not simply present the necessary information required to generate a dossier, but also assists (supports) the applicant in efficiently preparing the information to increase the likelihood of the pesticide being registered. The application document preparation support device 10 also accepts prompts and guidelines for the generation AI from the administrator terminal 50 and provides assistance and support to the applicant in efficiently preparing the information required to generate a dossier. Note that the application document preparation support device 10 may also accept information about pesticides from the applicant terminal 30 and present the necessary information required for the person in charge to create the dossier, rather than the generation AI, for example.

[0022] This application document preparation assistance device 10 has a processing function and a communication function, and functions as a server in the present system 1. In this embodiment, the application document preparation assistance device 10 is realized by an electronic device such as a personal computer such as a desktop or laptop, a tablet computer, or a smartphone. Therefore, in the following description, the application document preparation assistance device 10 may be referred to as a "server."

[0023] The applicant terminal 30 is a communication terminal used by an applicant, such as a practitioner, who requests the presentation of necessary information required for generating a dossier using the present system 1, and is a device with processing and communication functions. The applicant terminal 30 is connected to the application document preparation support device 10 via a communication network (network N), and is realized by, for example, an electronic device such as a desktop or laptop personal computer, or a tablet computer.

[0024] The administrator terminal 50 is a communication terminal used by an administrator such as a technical person who manages the entire system 1, including prompt settings and guideline registration, and is a device with processing and communication functions. This administrator terminal 50 is also connected to the application document preparation support device 10 via a communication network (network N), and is realized by an electronic device such as a desktop or laptop personal computer, or a tablet computer.

[0025] Furthermore, the network N is configured by the Internet, but is not particularly limited thereto, and may be a communication network such as a LAN (Local Area Network) or a WAN (Wide Area Network).The communication lines of the network N may be wired or wireless, or a combination of both may be used.

[0026] Although only one applicant terminal 30 is shown in the example of FIG. 1, the number is not particularly limited. Furthermore, although only one application document preparation support device 10 is shown, the application document preparation support device 10 is not limited to a standalone device, but may also be a distributed server system or cloud server that operates cooperatively by communicating via a network N such as the Internet.

[0027] (Hardware configuration) FIG. 2 is a block diagram showing the hardware configuration of the application document preparation assist device 10 according to this embodiment.

[0028] The application document preparation support device 10 includes a CPU (Central Processing Unit) 11, a ROM (Read Only Memory) 12, a RAM (Random Access Memory) 13, a bus 14, an input / output interface 15, an output unit 16, an input unit 17, a memory unit 18, and a communication unit 19.

[0029] CPU 11 executes various processes according to programs stored in ROM 12 or programs loaded from storage unit 18 to RAM 13. In other words, CPU 11 is a processor that executes various processes according to the programs and controls the overall operation of application document preparation assist device 10. The programs are, for example, an operating system or firmware for operating each unit of application document preparation assist device 10, or application software for implementing the functional blocks described below.

[0030] The RAM 13 also stores data and the like necessary for the CPU 11 to execute various processes. The CPU 11, ROM 12, and RAM 13 are interconnected via a bus 14. An input / output interface 15 is also connected to this bus 14. The input / output interface 15 is connected to an output unit 16, an input unit 17, a storage unit 18, and a communication unit 19.

[0031] The output unit 16 is composed of a display, a speaker, etc., and outputs various information as images and sounds. The input unit 17 is composed of a keyboard, mouse, microphone, camera, etc., and inputs various information in response to received instruction operations. Note that the output unit 16 and the input unit 17 may be integrated into one unit using, for example, a touch panel.

[0032] The storage unit 18 stores various data necessary for the application document preparation assist device 10 to execute information processing, and is configured, for example, with a hard disk, a DRAM (Dynamic Random Access Memory), or the like. The communication unit 19 communicates with other devices via a network N including the Internet.

[0033] The application document preparation assisting device 10 may be provided with a drive to which removable media such as a magnetic disk, optical disk, magneto-optical disk, or semiconductor memory can be appropriately attached. This drive allows a program read from the removable media to be installed in the storage unit 18. Furthermore, the removable media can also store various data stored in the storage unit 18 in the same manner as the storage unit 18.

[0034] The hardware configuration of the administrator terminal 50 of this embodiment is the same as that of the application document preparation assist device 10 described above.

[0035] (Application document preparation assistance device 10) FIG. 3 is a block diagram illustrating an example of the configuration of the application document preparation assist device 10 that functions as a server in this embodiment.

[0036] The application document preparation support device (server) 10 has a CPU 11 including a reception unit 110, a presentation unit 120, an output unit 130, a confirmation unit 140, a generation unit 150, a display unit 160, a proposal unit 170, and an identification unit 180. The server 10 also has a memory unit 18 including a guideline DB 210, a prompt DB 220, a template DB 230, a result information DB 240, a test report storage 250, and a dossier storage 260.

[0037] The reception unit 110 is a means having a function of receiving information about the pesticide that is the subject of the application. That is, the reception unit 110 receives information about the pesticide that is the subject of the application, such as the type, formulation, and use of the pesticide, in creating a dossier for pesticide registration based on the Agricultural Chemicals Control Act.

[0038] The reception unit 110 also has a function of receiving information on one or more review organizations requesting the registration of a pesticide. That is, the reception unit 110 receives information on one or more review organizations requesting the registration of a pesticide, taking into account that a user may wish to register a pesticide not only with one review organization but also with review organizations in multiple countries or regions.

[0039] The reception unit 110 also has the function of receiving information regarding the application results of pesticides that have been applied for in the past (hereinafter referred to as "result information") in advance. That is, the reception unit 110 receives result information on pesticides that have been applied for in the past, for example, in preparation for generating a dossier for the registration of the pesticide that is the subject of the application, in order to share by feeding back to the generation AI any deficiencies in test results or comments that have been pointed out by an examination organization in the past in applications for related pesticides. Examples of related pesticides include pesticides that have the same ingredients, pesticides that have the same product name, and pesticides that are similar, such as those that share some of the same ingredients.

[0040] The receiving unit 110 also functions as a means having a function of receiving reports of various test results (test reports) regarding the pesticide that is the subject of the application. That is, the receiving unit 110 receives test reports prepared by the applicant.

[0041] In the server 10 of this embodiment, the reception unit 110 performs the following functions to efficiently create dossiers related to the registration of pesticides. That is, the receiving unit 110 also functions as a means having a function of receiving dossiers of agricultural chemicals that have been applied for in the past.

[0042] The presentation unit 120 is a means having the function of presenting the necessary information required for the generation of pesticide application documents by the generation AI based on the guidelines for pesticide registration that have been received in advance. That is, when the reception unit 110 receives information about the pesticide that is the subject of the application, the presentation unit 120 presents all the necessary information required for the generation of the pesticide dossier based on the predetermined guidelines that have been received in advance by the generation AI. This necessary information may be presented, for example, for each pesticide formulation and active ingredient.

[0043] As a result, the present system 1 can efficiently perform tedious tasks such as checking the preparation of various information required for creating pesticide dossiers using generation AI. Furthermore, the present system 1 can resolve issues during the dossier generation stage, such as the inability to generate a dossier that meets registration requirements due to insufficient information, and can provide support for sufficient data preparation. Therefore, applicants can efficiently prepare in advance to generate dossiers with high registrability based on the required information provided.

[0044] The presentation unit 120 is also a means having a function of presenting the necessary information required for each review organization. Furthermore, the presentation unit 120 is also a means having a function of presenting all the necessary information required regardless of each review organization. In other words, when the reception unit 110 receives information from one or more review organizations requesting pesticide registration, the presentation unit 120 presents the necessary information that needs to be compiled in order to create a pesticide dossier in each country or region so that the presentation unit 120 can provide support for sufficient data preparation for review organizations in multiple countries or regions.

[0045] Specifically, the presentation unit 120 presents all the necessary information required for creating a dossier for the pesticide in question for each country or region based on the guidelines for each country or region that the generation AI has accepted in advance. For example, the presentation unit 120 presents all the necessary documents in accordance with the standards of the country or region that is considered to be the most difficult to review, such as one that requires the submission of a relatively large amount of documents. This allows applicants to efficiently and thoroughly prepare the materials (information) required for creating a dossier for registration in the desired country or region.

[0046] The presentation unit 120 also has the function of presenting information indicating the degree to which the required information is necessary for each review organization. Here, the information required for pesticide registration differs for each country or region. Therefore, when the reception unit 110 receives information on one or more review organizations requesting pesticide registration, the presentation unit 120 presents the required information along with information indicating the degree of necessity (degree of necessity). In this case, the presentation unit 120 can display the required information collectively for each country or region so that it is possible to understand at a glance what kind of required information is required for each country or region.

[0047] Here, the degree of necessity can be expressed as a symbol such as "O" for something that is likely to be required, "X" for something that is unlikely to be required, or "△" for something that is not required but would be desirable, or as a number indicating the proportion required, such as a percentage (%). The degree of necessity may be stored in advance, for example, in association with predetermined guidelines that have been accepted in advance, or information regarding the results of past pesticide applications may be accepted in advance, and the generation AI may calculate the degree of requirement based on the application results. This allows applicants to use the symbols and numbers as a reference to prioritize and prepare materials for creating a dossier.

[0048] The presentation unit 120 also has a function of presenting various test results as necessary information. That is, the presentation unit 120 presents, by the generation AI, the test contents that need to be performed to create various test results as information necessary for generating a dossier. This will enable applicants to efficiently understand what test results they must prepare when registering pesticides, and whether it is advisable for them to do so.

[0049] In addition to presenting test results, the presentation unit 120 also has the function of presenting information about materials that should be added, such as related literature or reference literature. That is, the presentation unit 120 presents, by the generation AI, information about materials such as related literature (papers) or reference literature (papers) that need to be attached or that should be attached, as information necessary for generating a dossier. This will enable applicants to efficiently understand what documents they should prepare when registering pesticides.

[0050] The presentation unit 120 also has a function of presenting test results to be added as necessary information according to the content of the accepted test report. That is, the presentation unit 120 accepts the test report prepared by the applicant, checks the content of the test report based on the guidelines, and if it determines that additional test results are necessary for the registration of the pesticide that is the subject of the application, it presents (alerts) a message to prompt the addition of missing test results. This allows for sufficient test results to be collected at registration, and preparations can be made for generating a dossier based on the test results. Furthermore, when it is unclear whether the contents of the test report comply with the guidelines, a prompt to add test results may be displayed.

[0051] The presentation unit 120 also functions as a means for presenting, as necessary information, information on materials that should be added, such as related literature or reference literature, depending on the content of the accepted test report. That is, the presentation unit 120 accepts the test report prepared by the applicant and checks the content of the test report based on the guidelines. As a result, if the presentation unit 120 determines that it is desirable to add, for example, related literature (e.g., papers) or reference literature (e.g., reference books) to the registration of the pesticide that is the subject of the application, it prompts the applicant to add the missing materials.

[0052] Furthermore, the presenting unit 120 may be configured to prompt the applicant to add additional materials when it is determined that the contents of the test report do not comply with the guidelines. In this way, the presenting unit 120 of this embodiment alerts the applicant about the necessary materials based on the confirmation of the contents of the test report. As a result, the system 1 will be able to gather sufficient documents (e.g., papers) for registration, which is expected to improve registration efficiency and also allow preparations to be made for generating dossiers based on the documents.

[0053] The output unit 130 is a means having a function of outputting result information for pesticides related to the pesticide that is the subject of the application when the necessary information is presented. That is, when the presentation unit 120 presents the necessary information required for generating the pesticide application documents, if there are any deficiencies or comments in the test results that have been pointed out in the past by an examination organization in the application for the related pesticide, the output unit 130 outputs the result information.

[0054] This allows the system 1 to efficiently prepare information for generating a dossier, such as adding test results or materials such as papers, by referring to the relevant result information so that similar deficiencies are not pointed out. In addition, it is advisable that the result information for pesticides previously applied for should not be limited to a single review organization, but should also include result information such as deficiencies in test results and comments pointed out by review organizations in other countries or regions in response to applications for the same pesticide. This allows the system 1 to prepare various information for generating a dossier that meets the registration requirements by referring to the results of the examination by the examination organization that is considered to be the most difficult.The system 1 can then prepare for generating a dossier that increases the possibility of registration.

[0055] In the server 10 of this embodiment, the output unit 130 performs the following various functions to efficiently create dossiers related to the registration of pesticides. In other words, the output unit 130 also functions as a means having a function of outputting, together with the generated dossier, information for the applicant to confirm the contents of the dossier. The output unit 130 also functions as a means having a function of outputting information that serves as the basis for the generated application documents. In addition, the output unit 130 also functions as a means having the function of outputting the differences between the guidelines (an example of a law) at the first time when the application documents were generated and the guidelines at a second time that is earlier than the first time, and the differences between the dossier generated at the first time and the dossier generated at the second time.

[0056] The confirmation unit 140 is a means having a function of confirming the contents of the test report based on the guidelines. That is, when the reception unit 110 receives a test report, the confirmation unit 140 confirms the contents of the test report, such as the test results and sentences, and the contents of the discussion section of the test report. Specifically, prior to generating a dossier, the confirmation unit 140 performs time-consuming tasks such as checking the numerical values ​​of the test results included in the test report, checking for human errors such as typos, omissions, and typing errors, and determining whether the report complies with the guidelines. This allows the system 1 to prepare for generating a highly accurate dossier that is free of errors in test results, consistent in the content of the discussion section, and in line with the guidelines.

[0057] In the server 10 of this embodiment, the confirmation unit 140 performs the following various functions to efficiently create dossiers related to the registration of pesticides. In other words, the confirmation unit 140 also functions as a means for checking the conformity of the generated dossier with the guidelines using the generation AI, determining the degree of certainty regarding registration based on the conformity of the content constituting the dossier with the guidelines, and confirming the information corresponding to this. The confirmation unit 140 also serves as a means having a function of confirming the consistency between the dossier and the test report after the dossier is generated. Furthermore, the confirmation unit 140 also serves as a means having a function of reconfirming the contents of the test report used to generate the dossier based on the guidelines after the dossier has been generated.

[0058] In the server 10 of this embodiment, the generation unit 150 performs the following various functions to efficiently create dossiers related to the registration of pesticides. That is, the generating unit 150 is a means having a function of generating a dossier of a pesticide by a generating AI based on the guidelines and test reports received in advance. The generating unit 150 also functions as a means having a function of generating a new dossier using dossiers of agricultural chemicals that have been applied for in the past. The generating unit 150 also functions as a means having a function of generating a new dossier using the result information of agricultural chemicals that have been applied for in the past.

[0059] In the server 10 of this embodiment, the display unit 160 has the following functions to efficiently create dossiers related to the registration of pesticides. That is, the display unit 160 is a means having a function of displaying information according to the accuracy of the registration of the dossier together with the generated dossier.

[0060] In the server 10 of this embodiment, the proposing unit 170 performs the following various functions to efficiently create dossiers related to the registration of pesticides. In other words, the suggestion unit 170 is a means having the function of suggesting that the contents of the dossier be checked in advance by an inspection body that conducts inspections regarding registration, based on information regarding the accuracy of the dossier according to its registrability. In addition, the suggestion unit 170 also serves as a means having the function of proposing corrections to the contents of the test report to ensure that the guidelines are met if the contents of the test report do not comply with the guidelines.

[0061] In the server 10 of this embodiment, the specifying unit 180 performs the following functions to efficiently create dossiers related to the registration of pesticides. In other words, the identification unit 180 is a means having the function of identifying the differences between the guidelines at the first period when the dossier was generated and the guidelines at the second period that is earlier than the first period for the pesticide that is the subject of the application, and also identifying the differences between the dossier generated at the first period and the dossier generated at the second period.

[0062] The guideline DB 210 is a means for storing guideline information. That is, the guideline DB 210 is a database that stores guidelines related to the registration of pesticides, and stores not only currently applicable guidelines but also guidelines that have been applied in the past. Furthermore, the guideline DB 210 is not limited to the guidelines of a single review organization, but also stores guidelines from review organizations in other countries and regions. These guidelines are registered in advance by the administrator terminal 50.

[0063] The prompt DB 220 is a means for storing prompts for creating dossiers for each classification of test reports. That is, the prompt DB 220 is a database that stores prompts that indicate the instructions to be executed by the generation AI for each pesticide when creating a dossier. These prompts are registered in advance by the administrator terminal 50.

[0064] The template DB 230 is a means for storing dossiers that have been submitted in the past to regulatory review bodies. That is, the template DB 230 is a database that stores past dossiers for related pesticides and dossiers for other pesticides, which are used as templates when generating dossiers. These past dossiers may be received from the applicant terminal 30, or may be registered in advance by the administrator terminal 50.

[0065] The result information DB 240 is a means for storing past result information published by the reviewing organization, which is the regulatory authority. In other words, the result information DB 240 is a database that stores deficiencies and comments pointed out by the reviewing organization in past reviews of pesticides. This result information may also be received from the applicant terminal 30, or may be registered in advance by the administrator terminal 50.

[0066] The test report storage 250 is a means for storing test reports uploaded by applicants. In other words, the test report storage 250 is a place for storing test reports created by applicants for generating dossiers. These test reports are accepted from the applicant terminal 30.

[0067] The dossier storage 260 is a means for storing the generated dossier. In other words, the dossier storage 260 is a place where the dossier generated by the generation unit 150 is stored so that it can be downloaded by the applicant terminal 30 (applicant).

[0068] As described above, the application document preparation support device 10 of this embodiment functions as a device including a reception unit 110, a presentation unit 120, an output unit 130, a confirmation unit 140, a generation unit 150, a display unit 160, a proposal unit 170, and an identification unit 180 by loading various programs (OS, applications, etc.) stored in the auxiliary storage device into the main storage device and executing them by the CPU 11.

[0069] Next, the basic processing flow in the application document preparation support system 1 according to this embodiment will be described. FIG. 4 is a sequence diagram showing an example of the application document preparation support process according to this embodiment.

[0070] First, in step S301, the administrator terminal 50 sets the classification of the test and registers the guidelines and prompts in the server 10. In addition, at the same time as registering the guidelines and prompts, the result information of pesticides that have been applied for in the past may also be registered in the server 10. In step S302, the server 10 stores the guidelines received from the administrator terminal 50 in the guideline DB 210, and stores the prompts in the prompt DB 220. Furthermore, when result information of a past dossier is received, it is saved in the result information DB 240.

[0071] In step S303, the applicant terminal 30 transmits to the server 10 information about the pesticide that is the subject of the application, such as the type, formulation, and use of the pesticide. In step S304, the server 10 uses the generation AI to identify a guideline corresponding to the pesticide based on the information about the pesticide received from the applicant terminal 30. Subsequently, in step S305, the server 10 uses the generation AI to identify the necessary information required for generating a dossier based on the guidelines. Then, in step S306, the server 10 presents the identified necessary information.

[0072] As described above, this system 1 automatically presents the necessary information needed to generate a dossier (application document) for a pesticide from information about that pesticide, and utilizes generation AI to analyze guidelines and efficiently identify and present the necessary information needed to generate the dossier.

[0073] Next, the flow of the application document generation preparation process in the application document preparation support system 1 according to this embodiment will be described. FIG. 5 is a flowchart showing an example of the basic operation of the application document generation preparation process in the application document generation assist device 10 according to this embodiment.

[0074] As shown in FIG. 5, in step S401, the accepting unit 110 performs processing to determine whether or not information related to pesticides has been accepted (received). If the receiving unit 110 has received information about pesticides (YES in S401), the process proceeds to step S402. On the other hand, if the receiving unit 110 has not received information about pesticides (NO in S401), the process in step S401 is repeated.

[0075] Next, in step S402, the presenting unit 120 identifies a guideline based on the received information about the pesticide, and performs processing to identify information (necessary information) necessary for generating a dossier based on the guideline. Furthermore, in step S403, the presenting unit 120 performs a process of presenting the information necessary for generating the identified dossier as necessary information. Thereafter, the operation of the application document preparation assisting device 10 ends (END).

[0076] Next, another flow of the application document generation preparation process in the present system 1 will be described. FIG. 6 is a flowchart showing another operation of the application document generation preparation process according to this embodiment.

[0077] As shown in FIG. 6, in step S501, the accepting unit 110 performs the process of determining whether or not information on pesticides has been accepted (received), similarly to step S401 described above. If the receiving unit 110 has received information about pesticides (YES in S501), the process proceeds to step S502. On the other hand, if the receiving unit 110 has not received information about pesticides (NO in S501), the process in step S501 is repeated.

[0078] Next, in step S502, the accepting unit 110 performs processing to determine whether or not it has accepted (received) information about one or more review organizations requesting the registration of the pesticide. If the reception unit 110 has received information about the certification body (YES in S502), the process proceeds to step S503. On the other hand, if the reception unit 110 has not received information about the certification body (NO in S502), the process in step S502 is repeated.

[0079] Next, in step S503, the presenting unit 120 identifies a guideline based on the received information about the examination organization, and performs processing to identify information (necessary information) necessary for generating a dossier based on the guideline. Furthermore, in step S504, the presenting unit 120 performs processing to present the necessary information required to generate the dossier identified for each examination institution, or all the identified necessary information. Thereafter, the operation of the application document preparation assisting device 10 ends (END).

[0080] FIG. 7 shows an example of a necessary information display screen 500 that displays necessary information according to this embodiment.

[0081] As shown in FIG. 7(A), the required information display screen 500 displays a selection receiving section 510 that receives the selection of the country for which the application is being made, and a required information display section 530 that displays the test contents required based on the selection made in the selection receiving section 510.

[0082] The selection receiving unit 510 displays a plurality of reception button images for receiving the selection of the country (an example of an examination body) to which the application is to be made. In the example of FIG. 7(A), reception button images are displayed for each country, such as EP (Europe), US (United States), JP (Japan), and CN (China). The applicant can select the country to which the application is to be made by performing a selection operation (e.g., clicking) on ​​that country. Note that it is also possible to select multiple countries using the reception button images.

[0083] The required information display unit 530 specifically displays the test details required for applying for pesticide registration in the selected country, in accordance with the country selection made using the reception button image of the selection receiving unit 510. In this example, the required information display unit 530 specifically displays the names of tests, such as AAA test, BBB test, CCC test, DDD test, and FFF test. Note that when the country selection made using the reception button image of the selection receiving unit 510 is changed, the names of the tests displayed in the required information display unit 530 change. In this way, in the system 1 of this embodiment, it is possible to display the test as necessary information required to generate a dossier specified for each examination institution.

[0084] Furthermore, as shown in FIG. 7(B), the required information display screen 500 displays an essential information display section 550 that is required regardless of the examination organization. The required information display section 550 specifically displays all test details as required information regardless of the examination organization, such as the country. In this example, the required information display section 550 specifically displays the names of the tests, such as the AAA test, the GGG test, and the ZZZ test. In this way, applicants can know in advance what tests are required for the registration of a pesticide before preparing a dossier.

[0085] FIG. 8 is an example of the necessity degree display 600 of this embodiment.

[0086] As shown in FIG. 8, necessity degree display 600 is information that indicates the degree to which necessary information is required for each examination organization, such as a country. Necessity degree display 600 is provided with test field 610 and degree column 630. The test field 610 item displays the specific names of various tests. Furthermore, degree column 630 is provided for each examination organization, such as a country. The degree column 630 indicates the possibility that each type of test will be required. Here, information that is likely to be required is displayed as "◯", information that is unlikely to be required is displayed as "X", and information that is not required but would be desirable to have is displayed as "△".

[0087] FIG. 9 is an example of the result information display 700 of this embodiment.

[0088] As shown in FIG. 9, the result information display 700 of this embodiment displays a pesticide type 710 and result information 720. The pesticide type 710 displays the specific name of the pesticide identified based on the received pesticide information. Furthermore, the result information 720 displays information relating to the application results in other countries (reviewing organizations) according to the pesticide type 710. In the example of Fig. 9, when an application for registration of a pesticide is made to a Japanese reviewing organization, for example, the results information 720 displays the points raised by Europe (EP) and the United States (US).

[0089] In this way, in this system 1, when an application for registration of a pesticide is submitted to one examination organization, information regarding the application results from other examination organizations is output.

[0090] Next, another flow of the application document generation preparation process in the present system 1 will be described. FIG. 10 is a flowchart showing another operation of the application document generation preparation process according to this embodiment.

[0091] As shown in FIG. 10, the processes in steps S601 to S603 are the same as those in steps S401 to S403 described above, and therefore a description thereof will be omitted. In step S604, the accepting unit 110 performs processing to determine whether or not result information on pesticides for which applications have been made in the past has been accepted (received). If the receiving unit 110 has received the result information (YES in S604), the process proceeds to step S605. On the other hand, if the receiving unit 110 has not received the result information (NO in S604), the operation of the application document preparation assist device 10 ends (END).

[0092] Next, in step S605, the output unit 130 performs a process of identifying result information for pesticides related to the pesticide that is the subject of the application. Furthermore, in step S605, the output unit 130 performs processing to output the identified result information. Thereafter, the operation of the application document preparation assisting device 10 ends (END).

[0093] Next, another flow of the application document generation preparation process in the present system 1 will be described. FIG. 11 is a flowchart showing another operation of the application document generation preparation process according to this embodiment.

[0094] As shown in FIG. 11, in step S701, the accepting unit 110 performs processing to determine whether or not a report on the results of various tests (test report) on the pesticide that is the subject of the application has been accepted (received). If the acceptance unit 110 has accepted the test report (YES in S701), the process proceeds to step S702. On the other hand, if the acceptance unit 110 has not accepted the test report (NO in S701), the operation of the application document preparation assistance device 10 ends (END).

[0095] Next, in step S702, the confirmation unit 140 performs a process of confirming the contents of the accepted test report based on the guidelines. Subsequently, in step S703, the checking unit 140 performs a process of determining whether or not there is missing information. That is, the checking unit 140 determines whether or not all of the information necessary for generating a dossier is included in the test report.

[0096] If the confirmation unit 140 determines that there is missing information (YES in S703), the process proceeds to step S704. On the other hand, if the acceptance unit 110 determines that there is no missing information (NO in S703), the operation of the application document preparation assistance device 10 ends (END). Then, in step S704, the presenting unit 120 performs a process of presenting necessary information to prompt the user to add the necessary information. That is, the presenting unit 120 presents, as necessary information, information on materials that are desirable to add, such as test results to be added, related literature, or reference literature. Thereafter, the operation of the application document preparation assisting device 10 ends (END).

[0097] FIG. 12 shows an example of the additional information suggestion screen 800 of this embodiment.

[0098] 12, the additional information suggestion screen 800 of this embodiment displays information that is missing for creating a dossier as a result of checking the contents of the test report. The additional information suggestion screen 800 displays additional test information 810 and additional related information 820.

[0099] The additional test information 810 displays information encouraging the applicant to add tests based on the contents of the test report. The additional test information 810 displays the specific details of the tests that are required. The additional test information 810 also displays information encouraging the applicant to add a consideration of the test results. Additional related information 820 specifically displays literature such as papers and technical documents that are required to create a dossier based on the contents of the test report.

[0100] In this way, by checking the test report in advance, the applicant can receive feedback on the additional information suggestion screen 800 before creating a dossier using the test report, making it possible to identify missing tests, literature, etc. in advance.

[0101] In this way, this system 1 utilizes generation AI to present the necessary information in order to efficiently generate dossiers for pesticide registration, and also efficiently assists in the confirmation of test results and documents, and advance preparations, to increase the registrability of pesticides.

[0102] As mentioned above, this system is designed to efficiently assist in the confirmation of test results and documents, as well as advance preparations, in order to efficiently prepare dossiers for the registration of pesticides, thereby increasing the likelihood of pesticides being registered.

[0103] Furthermore, this system 1 can also be applied as a system that efficiently assists in advance preparations for risk assessments that evaluate the impact of pesticides on the environment based on the results of toxicity tests and exposure assessments. To demonstrate that a pesticide is not harmful, four safety criteria must be guaranteed. Specifically, safety for crops, etc., confirmed through phytotoxicity tests; safety for consumers, safety for producers (pesticide users), and safety for the environment and ecosystem, confirmed through risk assessments. Of these, risk assessments evaluate the toxicity of the pesticide itself, which is the danger of the pesticide, and the exposure level related to intake by humans and other organisms. If this risk assessment determines that there is a risk, additional testing must be conducted. Therefore, the present system 1 accepts data on exposure assessment and hazard assessment of the pesticide to be evaluated and performs a risk assessment. The present system 1 then assists in the preparation of application documents by presenting information on any additional tests that may be required in advance based on the results of the risk assessment. In this way, the present system 1 may also be configured to present the necessary information required for pesticide risk assessment in advance using a generation AI in accordance with regulations.

[0104] In addition, this system 1 is expected to be applicable not only to generating application documents for the registration of pesticides, but also to generating application documents for approval and authorization of the manufacture and sale of chemical products, including pharmaceuticals, chemical substances, cosmetics, etc.

[0105] <Additional Notes> (Appendix 1) A system that assists in the preparation of application documents for pesticide registration, having one or more processors, The processor: We accept information about pesticides that are the subject of applications, The generation AI presents the necessary information required to prepare application documents for the pesticide based on the laws and regulations regarding the registration of the pesticide. Auxiliary systems. (Appendix 2) Accepting information from multiple review organizations applying for registration of said pesticides; 2. The assistance system of claim 1, which presents the required information for each review organization. (Appendix 3) An auxiliary system as described in Appendix 2, which presents information indicating the degree to which the necessary information is required for each review organization. (Appendix 4) An auxiliary system as described in Appendix 1, which accepts information from multiple review agencies applying for registration of the pesticide and presents the necessary information common to the multiple review agencies. (Appendix 5) An assistance system according to any one of appendices 1 to 4, which presents information about various tests as the required information. (Appendix 6) 6. The assistance system of claim 5, wherein in addition to the test, relevant information related to the test or reference information that is helpful in interpreting the test is presented as the required information. (Appendix 7) An auxiliary system as described in Appendix 1, which accepts information in advance regarding the application results of pesticides that have been applied for in the past, and outputs information regarding the application results of pesticides related to the pesticide that is the subject of the application. (Appendix 8) 10. An auxiliary system as described in Appendix 7, which, when applying for registration of a pesticide to one review organization, outputs information regarding the results of the application by other review organizations. (Appendix 9) 1. An auxiliary system as described in Appendix 1, which accepts test reports on the pesticides that are the subject of the application and verifies the contents of the reports based on the laws and regulations. (Appendix 10) 10. The assistance system of claim 9, wherein the assistance system suggests additional testing depending on the content of the received report. (Appendix 11) 10. The assistance system of claim 9, which suggests attaching relevant information related to the test or reference information that can be used to aid in the interpretation of the test, depending on the content of the received report. (Appendix 12) A device that assists in the preparation of application documents for pesticide registration, having one or more processors, The processor: We accept information about pesticides that are the subject of applications, The generation AI outputs the necessary information required to prepare application documents for the pesticide based on the laws and regulations related to the registration of the pesticide. Auxiliary equipment. (Appendix 13) A method for assisting in the preparation of application documents for pesticide registration, comprising: receiving information regarding the pesticide that is the subject of the application; a step of outputting necessary information required for preparing application documents for the pesticide by the generation AI based on laws and regulations related to the registration of the pesticide; An auxiliary method comprising: (Appendix 14) On the computer, A function to accept information about the pesticides that are the subject of the application, A function of outputting the necessary information required to prepare application documents for the pesticide using a generation AI based on laws and regulations related to the registration of the pesticide; A program that executes the following.

[0106] Although the present embodiment has been described above, the above-described embodiment is merely an example for facilitating understanding of the present invention and is not intended to limit the present invention. Furthermore, the present invention is not limited to the above-described embodiment, and modifications, improvements, etc. within the scope of achieving the object of the present invention are included in the present invention. [Explanation of symbols]

[0107] 10...Application document creation support device (server), 30...Applicant terminal, 50...Administrator terminal, 110...Reception unit, 120...Presentation unit, 130...Output unit, 140...Confirmation unit, 150...Generation unit, 160...Display unit, 170...Proposal unit, 180...Identification unit, 210...Guideline DB, 220...Prompt DB, 230...Template DB, 240...Result information DB, 250...Test report storage, 260...Dossier storage

Claims

1. A system that assists in the preparation of application documents for pesticide registration, having one or more processors, The processor: a storage means for storing guidelines for the registration of pesticides; By inputting predetermined prompts into the generation AI, necessary information required for creating application documents for the pesticide is generated; the prompt includes instructions for referencing information about the pesticide that is the subject of the application and analyzing the guidelines to generate the required information; Present the generated required information; If the content of the test report on the pesticide that is the subject of the application is determined to be inconsistent with the guidelines, the agency will propose to attach relevant information related to the test or reference information that can be used to help interpret the test. Auxiliary systems.

2. An auxiliary system as described in claim 1, which suggests attaching the relevant information or the reference information based on past review body comments regarding test reports in applications for pesticides related to the pesticide.

3. Accepting information from multiple review organizations applying for registration of said pesticides; The assistance system according to claim 1 , wherein the necessary information required for each of the review organizations is presented.

4. The assistance system according to claim 3 , wherein information indicating the degree to which the necessary information is required is presented for each of the review organizations.

5. Accepting information from multiple review organizations applying for registration of said pesticides; The assistance system according to claim 1 , wherein the system presents the required information common to a plurality of the review organizations.

6. 2. The assistance system according to claim 1, which receives information in advance regarding the results of applications for pesticides that have been applied for in the past, and outputs information regarding the application results for pesticides related to the pesticide that is the subject of the application.

7. 7. The auxiliary system according to claim 6, wherein when an application for registration of a pesticide is submitted to one examination organization, information relating to the application results from other examination organizations is output.

8. The assistance system of claim 1 , wherein additional tests are suggested depending on the content of the received report.

9. A device that assists in the preparation of application documents for pesticide registration, having one or more processors, The processor: a storage means for storing guidelines for the registration of pesticides; By inputting predetermined prompts into the generation AI, necessary information required for creating application documents for the pesticide is generated; the prompt includes instructions for referencing information about the pesticide that is the subject of the application and analyzing the guidelines to generate the required information; Present the generated required information; If the content of the test report on the pesticide that is the subject of the application is determined to be inconsistent with the guidelines, the agency will propose to attach relevant information related to the test or reference information that can be used to help interpret the test. Auxiliary equipment.

10. On the computer, a function of referring to a storage means for storing guidelines regarding the registration of pesticides; A function of generating necessary information required for creating application documents for the pesticide by inputting predetermined prompts into the generation AI; the prompt includes instructions for referencing information about the pesticide that is the subject of the application and analyzing the guidelines to generate the required information; a function of presenting the generated necessary information; A function to suggest the attachment of relevant information related to the test or reference information that can be used as a reference for the interpretation of the test when the content of the test report on the pesticide that is the subject of the application is determined to be inconsistent with the guidelines; and A program that executes the following.

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