A method, system, and storage medium for eCTD conversion of NeeS electronic documents.

Abstract

This invention discloses a method, system, and storage medium for converting NeeS electronic documents to eCTD format. The method involves selecting the country to be converted and downloading the corresponding national regulatory version template. After creating and naming each original folder according to preset rules, the NeeS electronic documents to be converted are placed into each original folder according to their function and category. Then, the method enters the first module content folder directory of the national regulatory template, parses the country and regulatory version according to the rules, and creates a regional backbone file. Next, the method locates the envelope information rule directory in the first module content folder, parses the documents in the envelope directory, and inserts them into the envelope information fields in the regional backbone file. Finally, the method locates the corresponding rule directories in the second, third, fourth, and fifth module content folders respectively, generating an eCTD format sequence file of the target country's regulatory version. This achieves the conversion of NeeS electronic documents into eCTD format materials according to preset rules.

Description

Technical Field

[0001] This invention relates to the field of information technology, and in particular to a method, system, and storage medium for eCTD conversion of NeeS electronic documents. Background Technology

[0002] Against the backdrop of electronic materials replacing paper materials in drug registration applications, ICH has promoted the standard application format of eCTD (Electronic Common Technical Document), which is being widely adopted in many countries and regions worldwide. eCTD is an electronic drug application format, serving as a universal document for the quality, safety, and efficacy of drugs. It is a form of information transmission from pharmaceutical companies to drug regulatory agencies, and its content must meet the requirements of a Common Technical Document (CTD). Applicants must first prepare various documents, data, and experimental data, then construct a structured eCTD document according to relevant regulations, and finally, the responsible person submits the application to the drug regulatory authority through a pre-established electronic transmission channel. Convenience, efficiency, standardization, and environmental friendliness are its main characteristics throughout the process, making eCTD favored by national drug regulatory authorities worldwide due to its numerous advantages in drug registration applications. With the development of eCTD technology, the previous NeeS (non-eCTD electronic submission) method is gradually being replaced, necessitating the rapid and efficient conversion of a large number of existing NeeS documents into eCTD documents to meet the subsequent demand for the eCTD format. Summary of the Invention

[0003] This invention addresses the shortcomings of existing technologies by providing an eCTD conversion method for NeeS electronic documents, comprising the following steps:

[0004] S1, select the country to be converted and download the corresponding national law version template, create and name each original folder according to the preset definition rules, and put the NeeS electronic documents to be converted into each original folder according to their function and category;

[0005] S2, enter the first module content folder directory of the national regulations template, parse the national and regulatory versions according to the rules, and create regional backbone files;

[0006] S3, Locate the envelope information rules directory in the first module content folder, parse the documents in the envelope directory, and fill them into the envelope information filling position in the regional backbone file;

[0007] S4. Locate the corresponding rule directories in the second, third, fourth, and fifth module content folders respectively, add specific directories for active ingredients, products, excipients, indications, and research information, and generate eCTD format sequence files for the target country's regulatory version.

[0008] Preferably, the original folder includes a regional regulations folder, an active ingredient folder, a product folder, an excipient folder, a research folder, and an indication folder.

[0009] Preferably, step S3 further includes: finding all directories in the first module content folder that contain entity documents, filtering out empty directories that do not contain entity documents, sequentially matching each entity file with the corresponding eCTD specification to generate leaf tags, verifying them with MD5 and adding each attribute.

[0010] Preferably, the eCTD conversion method for NeeS electronic documents further includes:

[0011] S5, copy the eCTD format sequence file as the original version sequence file to be replaced, identify the national regulatory version information in the original version sequence file to be replaced, establish a blank directory of the target regulatory file system using the version format of the target regulation, the target regulatory file system contains a tree-like parent-child node relationship, retain the original version sequence file to be replaced and identify the original version file system, establish a one-to-one file mapping between the original version file system and the target regulatory file system; extract the entity files in the original version sequence file from the original version file system, rebind them to the target regulatory file system, and generate new file paths.

[0012] Preferably, step S5 further includes:

[0013] S51, Identify the national regulatory version information in the original version sequence file to be replaced. The national regulatory version information includes the country number and the version number. The original version sequence file includes a skeleton file and multiple module content folders.

[0014] S52, Use the version format of the target regulations to create a blank directory of the target regulations file system. The target regulations file system contains a tree-like parent-child node relationship. Preserve the original version sequence files to be converted and identify the original version file system. Establish a one-to-one file mapping between the original version file system and the target regulations file system.

[0015] S53, after completing the file mapping, extract the entity files in the original version sequence files from the original version file system, rebind them to the target regulatory file system, and generate new file paths.

[0016] This invention also discloses an eCTD conversion system for NeeS electronic documents, comprising: a classification module, used to select the country to be converted and download the corresponding national regulatory version template, create and name each original folder according to preset definition rules, and place the NeeS electronic documents to be converted into each original folder according to their function and category; a file creation module, used to enter the first module content folder directory of the national regulatory template, parse the country and regulatory version according to the rules, and create a regional backbone file; an information filling module, used to find the envelope information rule directory in the first module content folder, parse the documents in the envelope directory, and fill them into the envelope information filling position in the regional backbone file; and a file generation module, used to find the corresponding rule directories in the second, third, fourth, and fifth module content folders respectively, add specific directories for active ingredients, products, excipients, indications, and research information, and generate an eCTD format sequence file of the target country's regulatory version.

[0017] Preferably, the original folder includes a regional regulations folder, an active ingredient folder, a product folder, an excipient folder, a research folder, and an indication folder.

[0018] Preferably, the information input module is further configured to find all directories containing entity documents in the first module content folder, filter out empty directories without entity documents, sequentially match each entity file with the corresponding eCTD specification to generate leaf tags, verify them with MD5, and add various attributes.

[0019] The present invention also discloses an eCTD conversion device for NeeS electronic documents, including a memory, a processor, and a computer program stored in the memory and executable on the processor, wherein the processor executes the computer program to implement the steps of any of the methods described above.

[0020] The present invention also discloses a computer-readable storage medium storing a computer program that, when executed by a processor, implements the steps of any of the methods described above.

[0021] The present invention discloses a method, system, and storage medium for converting NeeS electronic documents to eCTD format. This involves selecting the country to be converted and downloading the corresponding national regulatory version template. After creating and naming each original folder according to preset rules, the NeeS electronic documents to be converted are placed into the respective original folders according to their function and category. Then, the system enters the first module content folder directory of the national regulatory template, parses the country and regulatory version according to the rules, and creates a regional backbone file. Next, it locates the envelope information rule directory in the first module content folder, parses the documents in the envelope directory, and inserts them into the envelope information fields in the regional backbone file. Finally, it locates the corresponding rule directories in the second, third, fourth, and fifth module content folders respectively, generating an eCTD format sequence file of the target country's regulatory version. This achieves the conversion of NeeS electronic documents into eCTD format materials according to preset rules.

[0022] Additional aspects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. Attached Figure Description

[0023] The accompanying drawings, which are included to provide a further understanding of the invention and form part of this application, illustrate exemplary embodiments of the invention and, together with their description, serve to explain the invention and do not constitute an undue limitation thereof. In the drawings:

[0024] Figure 1 This is a flowchart illustrating the eCTD conversion method for NeeS electronic documents disclosed in this embodiment.

[0025] Figure 2 This is an example of an Australian M1 regulatory catalog template disclosed in this embodiment.

[0026] Figure 3 This is a schematic diagram of the specific process of step S5 disclosed in one embodiment.

[0027] Figure 4 This is a schematic diagram of a sequence of catalogs disclosed in this embodiment. Detailed Implementation

[0028] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. All other embodiments obtained by those skilled in the art based on the described embodiments of the present invention without creative effort are within the scope of protection of the present invention.

[0029] Unless otherwise defined, the technical or scientific terms used herein shall have the ordinary meaning as understood by one of ordinary skill in the art to which this invention pertains. The terms “first,” “second,” and similar terms used in the specification and claims of this patent application do not indicate any order, quantity, or importance, but are merely used to distinguish different components. Similarly, the terms “an” or “a” and similar terms do not indicate a limitation of quantity, but rather indicate the presence of at least one.

[0030] To meet the aforementioned requirements for converting NeeS documents to eCTD, this embodiment discloses an eCTD conversion method for NeeS electronic documents, as shown in the attached figure. Figure 1 As shown, the method includes the following steps:

[0031] Step S1: Select the country to be converted and download the corresponding national regulatory version template. Create and name each original folder according to the preset definition rules, and place the NeeS electronic documents to be converted into each original folder according to their function and category. The original folders include the regional regulations folder, active ingredient folder, product folder, excipient folder, research folder, and indication folder.

[0032] Specifically, the eCTD catalog formats that need to be converted mainly include the following: M1 region regulatory catalog, active ingredient catalog, product catalog, excipient catalog, research catalog, and indication catalog. This step uses preset definition rules to name folders, allowing the subsequent import program to identify and automatically generate different types of catalogs based on the folder names. Download the corresponding catalog format according to the country you need to convert, for example, see attached. Figure 2 The image shown is a template for Australia's M1 regulatory catalog. Below are some examples of preset rules.

[0033] [Country Number]@[eCTD Version Number]: The system automatically matches this rule in the m1 directory. au represents eCTD declarations for Australia. @ is used as a separator. 3.1 indicates the eCTD version the document is testing. Different versions have different numbering and directory name recognition rules, and the system automatically switches according to the country and version.

[0034] [Number] - [Directory Name]: This section uses the directory number and name, such as 100-correspondence, to plan the directory where the corresponding document should be placed. This directory automatically corresponds to the system directory and can automatically place files within the directory into the eCTD.

[0035]

Country Code

[0036]

Envelope Field

Envelope Field Value

[0037]

Active Ingredient

Active Ingredient Abbreviation

Manufacturer

Manufacturer Abbreviation

[0038]

Product

Product Abbreviation

Manufacturer

Dosage Form

[0039]

Extraneous Materials

Extraneous Materials Abbreviation

[0040]

Indications

Indications Abbreviation

[0041]

Research ID

Research Name

Research Category 1

Research Category 2

[0042] After the above directory organization phase, the relevant files have been placed into different directories according to their function and category.

[0043] Step S2: Enter the first module content folder directory of the national regulations template, parse the national and regulatory versions according to the rules, and create regional backbone files.

[0044] Specifically, navigate to the m1 directory, parse the country code and regulatory version of [Country Code]@[eCTD Version Code] according to the rules, create the au-region.xml file, and generate... <m1-au>Tags (similar in other countries).

[0045] Step S3: Locate the envelope information rules directory in the first module content folder, parse the documents in the envelope directory, and fill them into the envelope information filling position in the regional backbone file.

[0046] In this embodiment, step S3 further includes: finding all directories in the first module content folder that contain entity documents, filtering out empty directories that do not contain entity documents, sequentially matching each entity file with the corresponding eCTD specification to generate leaf tags, verifying them with MD5 and adding each attribute.

[0047] Specifically, it searches for all directories containing files within m1, filtering out empty directories. It then matches the corresponding eCTD specification based on the [number] - [directory name], such as generating a list for 100-correspondence. <m1-0-correspondence>1001-cover will generate <m1-0-1-cover>The corresponding file cover.pdf will then be generated. <leaf>The system automatically validates the tags using MD5 and adds various attributes. Repeat this process until the au-region.xml file contains all directories and files.

[0048] Step S4: Locate the corresponding rule directories in the second, third, fourth, and fifth module content folders, and add specific directories for active ingredients, products, excipients, indications, and research information to generate eCTD format sequence files for the target country's regulatory version. Following the same method, locate the corresponding rule directories in M2, M3, M4, and M5, and add specific directories such as [Active Ingredients], [Products], [Excipients], [Indications], and [Research].

[0049] In this embodiment, the eCTD conversion method for NeeS electronic documents also includes the following:

[0050] Step S5: Copy the eCTD format sequence file as the original version sequence file to be replaced; identify the national regulatory version information in the original version sequence file to be replaced; establish a blank directory of the target regulatory file system using the version format of the target regulation; the target regulatory file system contains a tree-like parent-child node relationship; retain the original version sequence file to be replaced and identify the original version file system; establish a one-to-one file mapping between the original version file system and the target regulatory file system; extract the entity files in the original version sequence file from the original version file system, rebind them to the target regulatory file system, and generate new file paths.

[0051] In this embodiment, as shown in the appendix Figure 3 As shown, step S5 may also include the following:

[0052] Step S51: Identify the national regulatory version information in the original version sequence file to be replaced. The national regulatory version information includes the country code and version number. The original version sequence file includes a skeleton file and multiple module content folders. Determine the national regulations and version number of the original data. (Appendix) Figure 4 The target sequence file to be converted is in a typical directory format, which is the original data file to be upgraded, including the skeleton file index.xml and module content folders m1-m5, etc.

[0053] In this embodiment, step S51 may include the following:

[0054] Within the first module content folder of the original version sequence file, search for the existence of a region skeleton file in the region folder. If it exists, identify the country code and version number contained in the skeleton file. Otherwise, search for a DTD or XSD format file in the tool folder within the first module content folder, and identify the country code and version number from the DTD or XSD format file.

[0055] If no DTD / XSD format files are found in the tools folder, or if the country code and version number are not identified, the corresponding regional skeleton file is recovered based on the directory or file containing country-specific information, and the country code and version number are identified again. The identified country code and version number are then matched with the corresponding supported target regulatory version in the system database.

[0056] Step S52: Use the version format of the target regulations to create a blank directory of the target regulations file system. The target regulations file system contains a tree-like parent-child node relationship. Preserve the original version sequence files to be converted and identify the original version file system. Establish a one-to-one file mapping between the original version file system and the target regulations file system.

[0057] Specifically, this step may include:

[0058] Use the version format of the target regulations to create blank folders and supporting files within the target regulations system. Each blank folder contains multiple module content folders. Use a tree structure to define the parent-child relationships of each blank folder and determine the order of sibling files. Specifically, first use the version format of the target regulations, such as us-ver3.3, to create blank directories for the target regulations system, such as module content folders m1-m5, and other necessary files, such as format definition files within util. Use a tree structure to define the parent-child relationships of the system files and strictly determine the order of sibling files.

[0059] The original version sequence files to be converted are retained, and the original version file structure system is identified by reading the directory file and the region skeleton file. The original version file structure system includes folder information, leaf node attributes and hierarchical relationships.

[0060] The original file structure is mapped one-to-one to the target regulatory file structure. If a complete mapping is not possible, the attributes of the first folder that cannot be mapped are obtained. The structural adjustment records of the associated first folder in the current regulatory database are queried, and the relevant folders are modified accordingly before the mapping is performed again. This step involves multiple mapping processes, as detailed below:

[0061] Each folder within the original file structure is mapped to the target regulatory file structure. If a target folder with the same name and path exists in the target regulatory file structure as the original folder in the original file structure, the original folder is successfully mapped. If a first folder exists in the original file structure that cannot be mapped, the structural adjustment records of the first folder between the original and target regulatory versions are queried from the regulatory history database. Based on these structural adjustment records, the corresponding system file adjustment rules are found and obtained. The first folder and / or related folders are modified according to the corresponding system file adjustment rules, and the resulting second folder is then re-mapped.

[0062] If the structure adjustment record contains a merge record of the first folder and the associated folder, then obtain the associated folder information and the merged target folder information from the merge record, and merge the first folder and the associated folder according to the merge rules in the system file adjustment rules, and then map them to the target folder.

[0063] In this embodiment, if the structural adjustment record contains a splitting record of the first folder, the mapping keywords of each folder name that has not been mapped in the target regulatory document structure system are extracted, and each mapping keyword is matched with the first folder name and / or the document names in the first folder to obtain multiple target folders corresponding to the keywords contained in the first folder name or the document names inside the first folder, which are used as the mapping targets of the first folder.

[0064] If the structural adjustment record contains a cancellation record for the first folder, then the name of the first folder and the names of each document within it are identified and the corresponding matching keywords are extracted. Based on the matching keywords, the associated keywords are retrieved from the database. The matching keywords and associated keywords are then matched with the names of each folder in the target regulatory document system that has not yet been mapped. If a match is successful, it is used as the mapping target for the first folder.

[0065] Step S53: After completing file mapping, extract the entity files from the original version sequence files from the original version file system, rebind them to the target regulatory file system, and generate new file paths. After file mapping is complete, extract the entity files (i.e., the original format files) from the original version sequence files from the original tree structure system, bind them to the target file's tree structure system, and generate new file paths. Identify the leaf tags of the original index.xml and extract basic file attributes such as title, operation, and ID. Once all files have been parsed, corresponding directories and file nodes will be generated in the system, and the relevant attributes of the original files will be recorded. After the original sequence is imported, the system supports manually adjusting files with incorrect positions and reconfiguring their associations. If multiple sequence files need to be imported, such as 0000, 0001, 0002, etc., they will be imported sequentially by referring to the steps in the above embodiments for version conversion or upgrade. The above achieves compatibility conversion between different versions of eCTD electronic declaration materials by establishing a one-to-one file mapping between the original version file system and the target regulatory file system; after completing the file mapping, the entity files in the original version sequence files are extracted from the original version file system, rebound to the target regulatory file system and generate new file paths.

[0066] This embodiment discloses an eCTD conversion method for NeeS electronic documents. The method involves selecting the country to be converted and downloading the corresponding national regulatory version template. After creating and naming the original folders according to preset rules, the NeeS electronic documents to be converted are placed into the respective original folders according to their function and category. Then, the method enters the first module content folder directory of the national regulatory template, parses the country and regulatory version according to the rules, and creates a regional backbone file. Next, it locates the envelope information rule directory in the first module content folder, parses the documents in the envelope directory, and inserts them into the envelope information fields in the regional backbone file. Then, it locates the corresponding rule directories in the second, third, fourth, and fifth module content folders, adds specific directories for active ingredients, products, excipients, indications, and research information, and generates an eCTD format sequence file of the target country's regulatory version. This achieves the conversion of NeeS electronic documents into eCTD format materials according to preset rules.

[0067] In another embodiment, an eCTD conversion system for NeeS electronic documents is also disclosed, comprising: a classification module, used to select the country to be converted and download the corresponding national regulatory version template, create and name each original folder according to preset definition rules, and place the NeeS electronic documents to be converted into each original folder according to their function and category; a file creation module, used to enter the first module content folder directory of the national regulatory template, parse the country and regulatory version according to the rules, and create a regional backbone file; an information filling module, used to find the envelope information rule directory in the first module content folder, parse the documents in the envelope directory, and fill them into the envelope information filling position in the regional backbone file; and a file generation module, used to find the corresponding rule directories in the second, third, fourth, and fifth module content folders respectively, add specific directories for active ingredients, products, excipients, indications, and research information, and generate an eCTD format sequence file of the target country's regulatory version.

[0068] In this embodiment, the original folder includes a regional regulations folder, an active ingredient folder, a product folder, an excipient folder, a research folder, and an indication folder.

[0069] In this embodiment, the information input module is also configured to find the paths where entity documents are stored in all directories of the first module content folder, filter out empty directories that do not contain entity documents, sequentially match the corresponding eCTD specification for each entity file to generate leaf tags, verify them with MD5 and add various attributes.

[0070] It should be noted that the various embodiments in this specification are described in a progressive manner, with each embodiment focusing on the differences from other embodiments. Similar or identical parts between embodiments can be referred to interchangeably. Regarding the eCTD conversion system for NeeS electronic documents disclosed in the embodiments, since it corresponds to the eCTD conversion method for NeeS electronic documents disclosed in the embodiments, the description is relatively simple, and relevant parts can be referred to the method section.

[0071] In other embodiments, an eCTD conversion apparatus for NeeS electronic documents is also provided, including a memory, a processor, and a computer program stored in the memory and executable on the processor, wherein the processor executes the computer program to implement the various steps of the eCTD conversion method for NeeS electronic documents as described in the above embodiments.

[0072] The NeeS electronic document eCTD conversion device may include, but is not limited to, a processor and a memory. Those skilled in the art will understand that the schematic diagram is merely an example of the NeeS electronic document eCTD conversion device and does not constitute a limitation on the NeeS electronic document eCTD conversion device. It may include more or fewer components than illustrated, or combine certain components, or use different components. For example, the NeeS electronic document eCTD conversion device may also include input / output devices, network access devices, buses, etc.

[0073] The processor can be a Central Processing Unit (CPU), or other general-purpose processors, digital signal processors (DSPs), application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), or other programmable logic devices, discrete gate or transistor logic devices, discrete hardware components, etc. A general-purpose processor can be a microprocessor or any conventional processor. This processor is the control center of the NeeS electronic document eCTD conversion device, connecting all parts of the NeeS electronic document eCTD conversion device via various interfaces and lines.

[0074] The memory can be used to store the computer program and / or modules. The processor implements various functions of the NeeS electronic document eCTD conversion device by running or executing the computer program and / or modules stored in the memory and calling the data stored in the memory. The memory may mainly include a program storage area and a data storage area. The program storage area may store the operating system, at least one application program required for a function, etc. In addition, the memory may include high-speed random access memory and non-volatile memory, such as hard disk, memory, plug-in hard disk, smart media card (SMC), secure digital (SD) card, flash card, at least one disk storage device, flash memory device, or other volatile solid-state storage device.

[0075] If the NeeS electronic document eCTD conversion device is implemented as a software functional unit and sold or used as an independent product, it can be stored in a computer-readable storage medium. Based on this understanding, all or part of the processes in the above embodiments of the present invention can also be implemented by a computer program instructing related hardware. The computer program can be stored in a computer-readable storage medium, and when executed by a processor, it can implement the steps of the various NeeS electronic document eCTD conversion method embodiments described above. The computer program includes computer program code, which can be in the form of source code, object code, executable files, or certain intermediate forms. The computer-readable medium can include: any entity or device capable of carrying the computer program code, recording media, USB flash drives, portable hard drives, magnetic disks, optical disks, computer memory, read-only memory (ROM), random access memory (RAM), electrical carrier signals, telecommunication signals, and software distribution media, etc. It should be noted that the content contained in the computer-readable medium may be appropriately added to or subtracted from the content as required by the legislation and patent practice in the jurisdiction. For example, in some jurisdictions, according to legislation and patent practice, the computer-readable medium may not include electrical carrier signals and telecommunication signals.

[0076] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

[0077] In summary, the above description is only a preferred embodiment of the present invention. All equivalent changes and modifications made within the scope of the claims of the present invention should be covered by the present invention.< / leaf>

Claims

1. A method of eCTD conversion of NeeS electronic documents, characterized by, The method comprises the following steps: S1, selecting a country to be converted and downloading a corresponding country regulation version template, establishing and naming each original folder according to preset definition rules, and placing NeeS electronic documents to be converted into each original folder according to functions and categories; S2, entering a first module content folder directory of the country regulation template, parsing the country and regulation version according to rules, and creating a regional backbone file; S3, finding an envelope information rule directory in the first module content folder, parsing the documents in the envelope directory, and filling the envelope information into the envelope information filling position in the regional backbone file; S4, finding corresponding rule directories in a second module content folder, a third module content folder, a fourth module content folder, and a fifth module content folder, respectively, adding active ingredients, products, adjuvants, indications, and research information specific directories, and generating eCTD format sequence files of the target country regulation version; S5, copying the eCTD format sequence files as original version sequence files to be replaced, identifying the country regulation version information in the original version sequence files to be replaced, establishing a blank directory of a target regulation file system using a version format of a target regulation, the target regulation file system containing a tree-shaped parent-child node relationship, preserving the original version sequence files to be replaced and identifying an original version file system, and establishing one-to-one file mapping between the original version file system and the target regulation file system; The entity files in the original version sequence files are separated from the original version file system, re-bound to the target regulation file system, and new file paths are generated, specifically including: S51, identifying the country regulation version information in the original version sequence files to be replaced, the country regulation version information including a country number and a version number, the original version sequence files including a skeleton file and a plurality of module content folders; S52, establishing a blank directory of a target regulation file system using a version format of a target regulation, the target regulation file system containing a tree-shaped parent-child node relationship, preserving the original version sequence files to be converted and identifying an original version file system, and establishing one-to-one file mapping between the original version file system and the target regulation file system; if the mapping cannot be completed, a first folder attribute that cannot be mapped is obtained, a structure adjustment record of the associated first folder recorded in a current regulation database is queried, and the related folders are modified and then the relationship mapping is performed again, specifically including: Each folder in the original version file structure system is mapped to the target regulation file structure system, if there is a target folder in the target regulation file structure system that is the same as the original folder name and path position in the original version file structure system, the original folder is successfully mapped; if there is a first folder that cannot be mapped in the original version file structure system, a structure adjustment record of the first folder recorded in a regulation history database between the original regulation version and the target regulation version is queried; corresponding system file adjustment rules are found and obtained according to the structure adjustment record, the first folder and / or the related folders are modified according to the corresponding system file adjustment rules, and the second folder formed after the modification is subjected to relationship mapping again. If the structural adjustment record contains a merge record of the first folder and the associated folder, the information of the associated folder in the merge record and the information of the target folder after merging are obtained, and the first folder and the associated folder are merged according to the merging rule in the system file adjustment rule and then mapped to the target folder; If the structural adjustment record contains a split record of the first folder, the mapping keywords of the folder names not yet mapped in the target regulatory file structure system are extracted, each mapping keyword is matched with the first folder name and / or the document name in the first folder, and the target folders corresponding to the keywords contained in the first folder name or the internal document name are obtained as the mapping target of the first folder; If the structural adjustment record contains a cancel record of the first folder, the first folder name and the internal document name are identified and the corresponding matching keywords are extracted, the associated keywords are obtained by querying the database according to the matching keywords, and the matching keywords and the associated keywords are matched with the folder names not yet mapped in the target regulatory file system, and if the matching is successful, the folder names are taken as the mapping target of the first folder; S53, after completing the file mapping, the entity files in the original version sequence file are separated from the original version file system, re-bound to the target regulatory file system, and a new file path is generated.

2. The eCTD conversion method of the NeeS electronic document according to claim 1, characterized in that: The original folder includes a regional regulatory folder, an active ingredient folder, a product folder, an auxiliary material folder, a research folder, and an indication folder.

3. The eCTD conversion method of NeeS electronic document according to claim 2, wherein: The S3 further includes: finding the path of the entity document stored in all directories of the first module content folder, filtering out the empty directories without entity documents, and sequentially matching each entity file with the corresponding eCTD specification generation leaf tag, checking with md5 and adding each attribute.

4. An eCTD conversion system of NeeS electronic documents, characterized by, It includes: The classification module is configured to select a country requiring conversion and download a corresponding country regulatory version template, establish and name each original folder according to a preset definition rule, and place the NeeS electronic document to be converted into each original folder according to the function and category; The file creation module is configured to enter the first module content folder directory of the country regulatory template, parse the country and the regulatory version according to the rule, and create a regional backbone file; The information supplementing module is configured to find the envelope information rule directory in the first module content folder, parse the document in the envelope directory, and supplement the envelope information filling position in the regional backbone file. The file generation module is used for respectively searching for corresponding rule directories in the second module content folder, the third module content folder, the fourth module content folder and the fifth module content folder, adding active ingredient, product, auxiliary material, indication, research information specific directory, and generating the eCTD format sequence file of the target country regulation version; copying the eCTD format sequence file as the original version sequence file to be replaced, identifying the country regulation version information in the original version sequence file to be replaced, using the version format of the target regulation to establish the blank directory of the target regulation file system, the target regulation file system containing the tree parent-child node relationship, reserving the original version sequence file to be replaced and identifying the original version file system, and establishing one-to-one file mapping between the original version file system and the target regulation file system. The entity files in the original version sequence file are separated from the original version file system, re-bound to the target regulatory file system, and a new file path is generated, specifically including: identifying the national regulatory version information to be replaced in the original version sequence file, the national regulatory version information including a national number and a version number, the original version sequence file including a skeleton file and a plurality of module content folders; using the version format of the target regulation to establish a blank directory of the target regulatory file system, the target regulatory file system containing a tree-shaped parent-child node relationship, retaining the original version sequence file to be converted and identifying the original version file system, establishing a one-to-one file mapping between the original version file system and the target regulatory file system; if the entire mapping cannot be completed, the first folder attribute that cannot be mapped is obtained, the structure adjustment record of the associated first folder recorded in the current regulation database is queried, the related folders are modified and the relationship mapping is performed again, specifically: mapping each folder in the original version file structure system to the target regulatory file structure system, if there is a target folder in the target regulatory file structure system that is the same as the original folder name and path position in the original version file structure system, the original folder is successfully mapped; if there is a first folder that cannot be mapped in the original version file structure system, the structure adjustment record of the first folder between the original regulatory version and the target regulatory version recorded in the regulation history database is queried; according to the structure adjustment record, the corresponding system file adjustment rule is found and obtained, the first folder and / or the related folder are modified according to the corresponding system file adjustment rule, and the second folder formed after the modification is subjected to relationship mapping again; if the structure adjustment record contains a merging record of the first folder and the associated folder, the associated folder information and the target folder information after merging in the merging record are obtained, and the first folder and the associated folder are merged and mapped to the target folder according to the merging rule in the system file adjustment rule; if the structure adjustment record contains a splitting record of the first folder, the mapping keywords of the folder names that have not been mapped in the target regulatory file structure system are extracted, each mapping keyword is matched with the first folder name and / or the document name in the first folder, a plurality of target folders containing the keywords in the first folder name or the internal document name are obtained as the mapping target of the first folder; if the structure adjustment record contains a cancellation record of the first folder, the first folder name and the internal document name are identified and the corresponding matching keywords are extracted, and the matching keywords are queried in the database to obtain associated keywords, the matching keywords and the associated keywords are matched with the folder names that have not been mapped in the target regulatory file system, if the matching is successful, they are taken as the mapping target of the first folder; after completing the file mapping, the entity files in the original version sequence file are separated from the original version file system, re-bound to the target regulatory file system, and a new file path is generated.

5. The eCTD conversion system of NeeS electronic documents according to claim 4, wherein: The original folder includes a regional regulation folder, an active ingredient folder, a product folder, an auxiliary material folder, a research folder and an indication folder.

6. The eCTD conversion system of NeeS electronic documents according to claim 5, wherein: The information supplementing module is further configured to find paths where entity documents are stored under all directories of the first module content folder, filter out empty directories without entity documents, and sequentially match each entity document with a corresponding eCTD specification to generate a leaf tag, check with md5 and add attributes.

7. An eCTD conversion apparatus for NeeS electronic documents, comprising a memory, a processor, and a computer program stored in the memory and executable on the processor, characterized in that: The processor executes the computer program to implement the steps of the method of any one of claims 1-3.

8. A computer-readable storage medium, the computer-readable storage medium storing a computer program, characterized in that: The computer program is executed by the processor to implement the steps of the method of any one of claims 1-3.

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