CN115809649A - eCTD conversion method, system and storage medium for NeeS electronic document - Google Patents
eCTD conversion method, system and storage medium for NeeS electronic document Download PDFInfo
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Abstract
The invention discloses an eCTD conversion method, a system and a storage medium of a NeeS electronic document, wherein the NeeS electronic document to be converted is respectively placed into original folders according to the action and the category after the original folders are established and named according to a preset definition rule by selecting the country to be converted and downloading a corresponding country rule version template; then entering a first module content folder directory of a national regulation template, and analyzing the national and regulation versions according to rules to create regional backbone files; then searching an envelope information rule directory in the first module content folder, analyzing a document in the envelope directory, and supplementing the document to an envelope information filling position in the regional backbone file; and then respectively searching 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 to generate an eCTD format sequence file of a target national regulation version, thereby realizing the conversion of the NeeS electronic document into an eCTD format material according to a preset rule.
Description
Technical Field
The invention relates to the technical field of information, in particular to an eCTD (eCTD-based transformation) method, system and storage medium for a NeeS electronic document.
Background
Under the background of the declaration that electronic materials replace paper materials, the ICH promotes the standard declaration format of the eCTD electronic general technical document, and the eCTD format is popularized in a plurality of countries and regions around the world. eCTD is an electronic medicine declaration format and is a general file in the aspects of quality, safety and effectiveness of medicines. This is a form of information transmission from pharmaceutical companies to drug regulatory agencies, the contents of which are required to meet the requirements of the Common Technical Document (CTD). An applicant firstly writes various data, experimental data and the like, then constructs an eCTD structured document according to relevant regulation requirements, and then submits a declaration document to a drug monitoring department through an electronic transmission channel established in advance by a declaration principal. In the whole process, the characteristics of convenience, high efficiency, standardization and environmental protection are main characteristics, so that the eCTD is favored by domestic drug approval departments of all countries due to the advantages of the eCTD in the drug registration and declaration link. With the development of the eCTD technology, the previous NeeS mode declaration (non-eCTD electronic submission) is gradually replaced, and a large amount of original NeeS mode documents are urgently required to be quickly and efficiently converted into eCTD documents to meet the requirement of using an eCTD format subsequently.
Disclosure of Invention
Aiming at the defects in the prior art, the invention provides an eCTD conversion method of a NeeS electronic document, which comprises the following steps:
s1, selecting a country to be converted, downloading a corresponding country rule version template, establishing and naming original folders according to a preset definition rule, and respectively placing a NeeS electronic document to be converted into the original folders according to functions and categories;
s2, entering a first module content folder directory of a national regulation template, analyzing the country and the regulation version according to rules, and creating a regional backbone file;
s3, searching an envelope information rule directory in the first module content folder, analyzing a document in the envelope directory, and supplementing the document to an envelope information filling position in the regional backbone file;
and S4, respectively searching 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 ingredients, products, auxiliary materials, indications and research information specific directories, and generating an eCTD format sequence file of a target national regulation version.
Preferably, the original folders comprise a regional regulation folder, an active ingredient folder, a product folder, an auxiliary material folder, a research folder and an indication folder.
Preferably, the step S3 further includes: and searching paths for storing entity documents under all directories of the first module content folder, filtering empty directories without entity documents, matching corresponding eCTD specifications for each entity document in sequence to generate leaf tags, checking by using md5, and adding each attribute.
Preferably, the eCTD conversion method for the NeeS electronic document further includes:
s5, copying an eCTD format sequence file as an original version sequence file to be replaced, identifying national regulation version information in the original version sequence file to be replaced, establishing a blank directory of a target regulation file system by using a version format of a target regulation, wherein the target regulation file system comprises a tree-shaped parent-child node relation, reserving the original version sequence file to be replaced, identifying the original version file system, and establishing one-to-one file mapping of the original version file system and the target regulation file system; and extracting the entity files in the original version sequence files from the original version file system, rebinding the entity files to the target rule file system, and generating a new file path.
Preferably, the step S5 further includes:
s51, identifying national regulation version information in an original version sequence file to be replaced, wherein the national regulation version information comprises a national number and a version number, and the original version sequence file comprises a skeleton file and a plurality of module content folders;
s52, establishing a blank directory of a target rule file system by using a version format of a target rule, wherein the target rule file system comprises a tree parent-child node relationship, reserving an original version sequence file to be converted, identifying the original version file system, and establishing one-to-one file mapping between the original version file system and the target rule file system;
and S53, after the file mapping is completed, extracting the entity file in the original version sequence file from the original version file system, rebinding the entity file to the target rule file system, and generating a new file path.
The invention also discloses an eCTD conversion system of the NeeS electronic document, which comprises the following steps: the classification module is used for selecting countries needing conversion, downloading corresponding national rule version templates, establishing and naming original folders according to preset definition rules, and respectively placing the NeeS electronic documents to be converted into the original folders according to functions and categories; the file creating module is used for entering a first module content folder directory of a national regulation template, analyzing the national and regulation versions according to rules and creating regional backbone files; the information supplementing module is used for searching an envelope information rule directory in the first module content folder, analyzing a document in the envelope directory and supplementing the document to an envelope information filling position in the regional backbone file; and the file generation module is used for respectively searching 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 ingredients, products, auxiliary materials, indications and research information specific directories, and generating an eCTD (eCTD) format sequence file of a target national regulation version.
Preferably, the original folders comprise a regional regulation folder, an active ingredient folder, a product folder, an auxiliary material folder, a research folder and an indication folder.
Preferably, the information supplementing module is further configured to find a path in which entity documents are stored in all directories of the first module content folder, filter an empty directory without the entity documents, sequentially match corresponding eCTD specifications to each entity document to generate a leaf tag, check with md5, and add each attribute.
The invention also discloses an eCTD conversion device of a NeeS electronic document, which comprises a memory, a processor and a computer program stored in the memory and capable of running on the processor, wherein the processor executes the computer program to realize the steps of any one of the methods.
The invention also discloses a computer-readable storage medium, in which a computer program is stored, which, when being executed by a processor, carries out the steps of the method as set forth in any one of the above.
According to the eCTD conversion method, the eCTD conversion system and the storage medium of the NeeS electronic document, the states needing to be converted are selected, corresponding state rule version templates are downloaded, and the NeeS electronic document to be converted is respectively placed into each original folder according to the action and the category after each original folder is established and named according to the preset definition rule; then entering a first module content folder directory of a national regulation template, and analyzing the national and regulation versions according to rules to create regional backbone files; then searching an envelope information rule directory in the first module content folder, analyzing a document in the envelope directory, and supplementing the document to an envelope information filling position in the regional backbone file; and then 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 are respectively searched to generate an eCTD format sequence file of a target national regulation version, so that the NeeS electronic document is converted into an eCTD format material according to a preset rule.
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.
Drawings
The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this application, illustrate embodiment(s) of the invention and together with the description serve to explain the invention without limiting the invention. In the drawings:
fig. 1 is a schematic flow chart of an eCTD conversion method for a NeeS electronic document disclosed in this embodiment.
Fig. 2 is an example of the australian M1 regulation catalog template disclosed in this embodiment.
Fig. 3 is a schematic flowchart of step S5 according to an embodiment.
Fig. 4 is a schematic diagram of a sequence of directories disclosed in this embodiment.
Detailed Description
In order to make the objects, 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 drawings of the embodiments of the present invention. It should be apparent that the described embodiments are only some of the embodiments of the present invention, and not all of them. All other embodiments, which can be derived by a person skilled in the art from the described embodiments of the invention without inventive step, are within the scope of protection of the invention.
Unless defined otherwise, technical or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The use of "first," "second," and similar terms in the description and in the claims of the present application does not denote any order, quantity, or importance, but rather the terms are used to distinguish one element from another. Also, the use of the terms a, an, etc. do not denote a limitation of quantity, but rather denote the presence of at least one.
In order to meet the requirement of NeeS for converting the eCTD, the embodiment discloses an eCTD conversion method for a NeeS electronic document, as shown in fig. 1, the method includes the following steps:
s1, selecting a country to be converted, downloading a corresponding country rule version template, establishing and naming original folders according to a preset definition rule, and respectively placing a NeeS electronic document to be converted into each original folder according to the action and the category. The original folders comprise a regional regulation folder, an active ingredient folder, a product folder, an auxiliary material folder, a research folder and an indication folder.
Specifically, the eCTD directory format mainly has the following types to be converted: m1 regional regulation catalogue, active ingredient catalogue, product catalogue, auxiliary material catalogue, research catalogue, indication catalogue. The folder is named through a preset definition rule, so that the subsequent import program can identify and automatically generate different types of directories according to the name of the folder. According to the country to be converted, a corresponding catalog format is downloaded, such as the catalog template of the M1 regulation in australia shown in fig. 2. Some examples of preset rules follow.
[ country number ] @ [ eCTD version number ]: the system automatically matches this rule to the m1 directory. au stands for eCTD declaration for Australia. @ is used as a segmentation symbol. 3.1, the eCTD version of the trial document is shown, the corresponding numbers and directory name identification rules of different versions are different, and the system is automatically switched according to the country and the version.
[ NUMBER ] to [ CATALOG NAME ]: the directory where the corresponding document is to be placed is planned by the directory number and name, such as 100-coreespondance. The directory corresponds to the system directory automatically, and files below the directory can be placed in the eCTD automatically.
[ national number ] -envelope: and identifying corresponding envelope information through the country number.
[ envelope field ] @ [ envelope field value ]: and the eCTD envelope information is completely supplemented in an envelope field @ envelope value mode. This directory allows for multiple levels of nesting.
[ active ingredient ] @ [ abbreviation of active ingredient ] # producer @ [ abbreviation of producer ]: the system automatically matches this rule in the subdirectory of m 23-intersection, m32-body-of-data, such as "Ibuprofen @ Ibuprofen # Bright Zhiyun @ mdzy" to identify that the active ingredient is Ibuprofen and the manufacturer is Bright. Optional padding following # number.
[ PRODUCTS ] PRODUCT [ PRODUCT abbreviations ] # [ PRODUCTS ] # [ FORMULATION ]: the system automatically matches this rule into a subdirectory of m 23-interaction, m 32-body-of-data. Optional padding following # number.
[ adjuvants ] @ [ adjuvants abbreviation ]: the system automatically matches this rule into the subdirectory of the m32p 5-control-of-drug-product.
[ indications ] @ [ abbreviations for indications ]: the system automatically matches this rule into a subdirectory of m27-clinical-summary, m 53-clinical-study-reports.
[ study number ] @ [ study name ] # [ study class 1 ] # [ study class 2 ]: the system automates to the parent directory of the study corresponding to m4 and m5, directories such as m4211-primary-pharmacodynamics, m5311-bioavailability-study-reports, etc., match this rule. Optional padding following # number. If there are multiple study categories, multiple records are created. Research is also distinguished according to countries, such as China and the United states, a system is required to automatically generate stf and other format files and dataset data sets, and the European Union automatically creates extension nodes according to directory names.
After the catalog sorting stage, the corresponding files are placed in different catalogs according to the functions and categories.
And S2, entering a first module content folder directory of a national regulation template, analyzing the country and the regulation version according to rules, and creating a regional backbone file.
Specifically, an m1 directory is entered, and according to rules, a country and a regulation version are parsed, an au-region. Xml file is created, and an < m1-au > tag (similar in other countries) is generated.
And S3, searching an envelope information rule directory in the first module content folder, analyzing a document in the envelope directory, and supplementing the document to an envelope information filling position in the regional backbone file.
In this embodiment, the step S3 further includes: and searching paths for storing entity documents under all directories of the first module content folder, filtering empty directories without the entity documents, matching corresponding eCTD specifications to each entity document in sequence to generate a leaf label, checking by using md5, and adding each attribute.
Specifically, a path with files under all directories of m1 is found, and empty directories are filtered out. According to the matching of the [ serial number ] - [ directory name ] with the corresponding eCTD specification, if 100-correspondance, the < m 1-0-correspondance > is generated, if 1001-cover, the < m1-0-1-cover > is generated, and if the corresponding file cover. Xml file contains all directories and files.
And S4, respectively searching 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 ingredients, products, auxiliary materials, indications and research information specific directories, and generating an eCTD (eCTD) format sequence file of a target national regulation version. According to the mode, corresponding rule catalogues in M2, M3, M4 and M5 are searched, and specific catalogues such as active ingredients, products, auxiliary materials, indications and researches are added.
In this embodiment, the eCTD conversion method for the NeeS electronic document further includes the following steps.
S5, copying an eCTD format sequence file as an original version sequence file to be replaced, identifying national regulation version information in the original version sequence file to be replaced, establishing a blank directory of a target regulation file system by using a version format of a target regulation, reserving the original version sequence file to be replaced, identifying the original version file system, and establishing one-to-one file mapping of the original version file system and the target regulation file system; and extracting the entity files in the original version sequence files from the original version file system, rebinding the entity files to the target rule file system, and generating a new file path.
In this embodiment, as shown in fig. 3, the step S5 may further include the following steps.
Step S51, identifying national regulation version information in an original version sequence file to be replaced, wherein the national regulation version information comprises a national number and a version number, and the original version sequence file comprises a skeleton file and a plurality of module content folders. The national regulation and the version number of the original material are determined. Fig. 4 shows a general directory format of a target sequence file to be converted, i.e. an original material file to be upgraded, which includes a skeleton file index.
In the present embodiment, the step S51 may include the following.
Inquiring whether an area skeleton file exists in an area folder or not in a first module content folder of an original version sequence file, if so, identifying a country number and a version number in the skeleton file, otherwise, searching a dtd or xsd format file in a tool folder in the first module content folder, and identifying the country number and the version number from the dtd or xsd format file.
If the dtd/xsd format file in the tool folder is not searched or the country number and the version number are not identified, the corresponding regional skeleton file is restored according to the directory or the file with the country characteristic content, and the country number and the version number are identified again. And identifying the acquired country number and version number, and matching the corresponding target regulation version supported and converted in the system database.
And S52, establishing a blank directory of a target rule file system by using a version format of the target rule, wherein the target rule file system comprises a tree parent-child node relationship, reserving an original version sequence file to be converted, identifying the original version file system, and establishing one-to-one file mapping between the original version file system and the target rule file system.
Specifically, the step may include:
establishing each blank folder and support file in a target regulation system by using a version format of a target regulation, wherein each blank folder comprises a plurality of module content folders, defining the parent-child relationship of each blank folder by using a tree structure, and determining the sequence of brothers. Specifically, the version format of the target regulation, such as us-ver3.3, is used firstly, a blank directory of the target regulation system, such as module content folders m1-m5, and other necessary files, such as format definition files in util, are established, the tree structure is used for defining the parent-child relationship of the system files, and the sequence between brothers and brothers is strictly determined.
The original version sequence file to be converted is retained and an original version file structure system is identified by reading the directory file and the region skeleton file, the original version file structure system including folder information, leaf node attributes and a superior-inferior relationship.
And mapping the original edition file structure system into a target regulation file structure system in a one-to-one manner, acquiring the attribute of the first folder which cannot be mapped if the mapping cannot be completed, inquiring the structure adjustment record which is recorded in the existing regulation database and is associated with the first folder, and performing relational mapping again after the relevant folder is correspondingly modified. The step includes a multiple relation mapping process, which specifically includes:
and mapping all folders in the original edition file structure system into a target regulation file structure system respectively, wherein if a target folder with the same name and path position as the original folder in the original version file structure system exists in the target regulation file structure system, the original folder is successfully mapped. And if the first folder which cannot be mapped exists in the structural system of the original edition file, inquiring the structural adjustment record of the first folder between the original regulation version and the target regulation version, which is recorded in the regulation history database. And searching and acquiring a corresponding system file adjustment rule according to the structure adjustment record, modifying the first folder and/or the related folder according to the corresponding system file adjustment rule, and performing re-relational mapping on the second folder formed after modification.
And if the structure adjustment record contains a combination record of the first folder and the associated folder, acquiring associated folder information and combined target folder information in the combination record, combining the first folder and the associated folder according to a combination rule in the system file adjustment rule, and mapping the first folder and the associated folder to the target folder.
In this embodiment, if the structure adjustment record includes a splitting record of the first folder, a mapping keyword of each folder name that does not implement mapping in the target regulation file structure system is extracted, each mapping keyword is matched with the first folder name and/or each document name in the first folder, and a plurality of target folders corresponding to the keywords included in the first folder name or the document names therein are obtained as mapping targets of the first folder.
And if the structure adjustment record contains a cancel record of the first folder, identifying the name of the first folder and the names of all internal documents, extracting corresponding matched keywords, inquiring in a database according to the matched keywords to obtain associated keywords, respectively matching the matched keywords and the associated keywords with the names of all folders which are not mapped in a target rule file system, and if the matching is successful, taking the matched keywords and the associated keywords as the mapping target of the first folder.
And S53, after the file mapping is finished, extracting the entity file in the original version sequence file from the original version file system, binding the entity file to the target rule file system again, and generating a new file path. And after the file mapping is finished, extracting the entity file in the original version sequence file, namely the original format file, from the original tree structure system, binding the tree structure system of the target file, and generating a new file path. Xml's leaf tag is identified, and basic attributes of the file such as title, operation, ID, etc. are extracted. And generating corresponding directories and file nodes in the system until all files are analyzed, and recording the related attributes of the original files. After the original sequence is imported, the system supports manual adjustment of files with errors in position and reconfigures the association relationship of the files. If a plurality of sequence files are required to be imported, such as 0000,0001,0002 and the like, the sequence files are imported by sequentially referring to the steps in the above embodiments for version conversion or upgrading. Establishing a one-to-one file mapping of an original edition file system and a target regulation file system; after the file mapping is completed, the entity files in the original version sequence files are extracted from the original version file system, bound to the target regulation file system again and generate a new file path, and compatible conversion of eCTD electronic declaration materials of different versions among different regulation versions is achieved.
According to the eCTD conversion method of the NeeS electronic document disclosed by the embodiment, the countries needing conversion are selected, corresponding national regulation version templates are downloaded, and after the original folders are established and named according to the preset definition rules, the NeeS electronic document to be converted is respectively placed into the original folders according to the action and the category; then entering a first module content folder directory of a national regulation template, and analyzing the national and regulation versions according to rules to create regional backbone files; then searching an envelope information rule directory in the first module content folder, analyzing a document in the envelope directory, and supplementing the document to an envelope information filling position in the regional backbone file; and then respectively searching 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, adding active ingredients, products, auxiliary materials, indications and research information specific directories, and generating an eCTD format sequence file of a target national regulation version. The NeeS electronic document is converted into an eCTD format material according to a preset rule.
In another embodiment, an eCTD conversion system for NeeS electronic documents is further disclosed, comprising: the classification module is used for selecting countries needing conversion, downloading corresponding national rule version templates, establishing and naming original folders according to preset definition rules, and respectively placing the NeeS electronic documents to be converted into the original folders according to functions and categories; the file creating module is used for entering a first module content folder directory of a national rule template, analyzing the country and rule versions according to rules and creating regional backbone files; the information supplementing module is used for searching an envelope information rule directory in the content folder of the first module, analyzing a document in the envelope directory and supplementing the document to an envelope information filling position in the regional backbone file; and the file generation module is used for respectively searching 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 ingredients, products, auxiliary materials, indications and research information specific directories, and generating an eCTD format sequence file of a target national regulation version.
In this embodiment, the original folders include a regional regulation folder, an active ingredient folder, a product folder, an auxiliary material folder, a research folder, and an indication folder.
In this embodiment, the information supplementing module is further configured to find a path in which entity documents are stored in all directories of the first module content folder, filter out empty directories without entity documents, sequentially match corresponding eCTD specifications for each entity document to generate a leaf tag, check with md5, and add each attribute.
It should be noted that, in the present specification, the embodiments are described in a progressive manner, each embodiment focuses on differences from other embodiments, and the same and similar parts among the embodiments may be referred to each other. For the eCTD conversion system of the NeeS electronic document disclosed by the embodiment, the description is relatively simple because the eCTD conversion system corresponds to the eCTD conversion method of the NeeS electronic document disclosed by the embodiment, and related points can be referred to the description of the method part.
In further embodiments, there is provided 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, wherein the processor when executing the computer program implements the steps of the eCTD conversion method for NeeS electronic documents as described in the embodiments above.
The eCTD conversion device of the NeeS electronic document can include, but is not limited to, a processor and a memory. It will be appreciated by those skilled in the art that the schematic diagram is merely an example of the eCTD conversion apparatus of a NeeS electronic document and does not constitute a limitation of the eCTD conversion apparatus of a NeeS electronic document, and may include more or fewer components than those shown, or some components in combination, or different components, for example, the eCTD conversion apparatus of a NeeS electronic document may also include input and output devices, network access devices, buses, etc.
The Processor may be a Central Processing Unit (CPU), other general purpose Processor, a Digital Signal Processor (DSP), an Application Specific Integrated Circuit (ASIC), an off-the-shelf Programmable Gate Array (FPGA) or other Programmable logic device, discrete Gate or transistor logic, discrete hardware components, etc. The general purpose processor may be a microprocessor or the processor may be any conventional processor or the like that is the control center for the eCTD conversion equipment of the NeeS electronic document, with various interfaces and lines connecting the various parts of the eCTD conversion equipment of the entire NeeS electronic document.
The memory may be configured to store the computer programs and/or modules, and the processor may implement the various functions of the eCTD conversion apparatus device of the NeeS electronic document by executing or executing the computer programs 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, wherein the program storage area may store an operating system, an application program required for at least one function, and the like, and the memory may include a high speed random access memory, and may further include a non-volatile memory, such as a hard disk, a memory, a plug-in hard disk, a Smart Media Card (SMC), a Secure Digital (SD) Card, a Flash memory Card (Flash Card), at least one magnetic disk storage device, a Flash memory device, or other volatile solid state storage device.
The eCTD conversion device of the NeeS electronic document can be stored in a computer readable storage medium if the eCTD conversion device is realized in the form of a software functional unit and sold or used as a stand-alone product. Based on such understanding, all or part of the processes in the method according to the embodiments of the present invention may also be implemented by a computer program, which may be stored in a computer-readable storage medium, and when the computer program is executed by a processor, the computer program may implement the steps of the foregoing eCTD conversion method embodiments of the NeeS electronic document. Wherein the computer program comprises computer program code, which may be in the form of source code, object code, an executable file or some intermediate form, etc. The computer-readable medium may include: any entity or device capable of carrying the computer program code, recording medium, usb disk, removable hard disk, magnetic disk, optical disk, computer Memory, read-Only Memory (ROM), random Access Memory (RAM), electrical carrier wave signals, telecommunications signals, software distribution medium, and the like. It should be noted that the computer readable medium may contain content that is subject to appropriate increase or decrease as required by legislation and patent practice in jurisdictions, for example, in some jurisdictions, computer readable media does not include electrical carrier signals and telecommunications signals as is required by legislation and patent practice.
Finally, it should be noted that: the above examples are only intended to illustrate the technical solution of the present invention, and not to limit it; although the present invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some technical features may be equivalently replaced; and the modifications or the substitutions do not make the essence of the corresponding technical solutions depart from the scope of the technical solutions of the embodiments of the present invention.
In summary, the above-mentioned embodiments are only preferred embodiments of the present invention, and all equivalent changes and modifications made in the claims of the present invention should be covered by the claims of the present invention.
Claims (10)
1. An eCTD conversion method of a NeeS electronic document is characterized by comprising the following steps:
s1, selecting a country to be converted, downloading a corresponding country rule version template, establishing and naming original folders according to a preset definition rule, and respectively placing a NeeS electronic document to be converted into the original folders according to functions and categories;
s2, entering a first module content folder directory of a national regulation template, analyzing the country and the regulation version according to rules, and creating a regional backbone file;
s3, searching an envelope information rule directory in the first module content folder, analyzing a document in the envelope directory, and supplementing the document to an envelope information filling position in the regional backbone file;
and S4, respectively searching 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 ingredients, products, auxiliary materials, indications and research information specific directories, and generating an eCTD format sequence file of a target national regulation version.
2. The eCTD conversion method for NeeS electronic documents according to claim 1, wherein: the original folders comprise a regional regulation folder, an active ingredient folder, a product folder, an auxiliary material folder, a research folder and an indication folder.
3. An eCTD conversion method of a NeeS electronic document according to claim 2, characterized in that: the step S3 further includes: and searching paths for storing entity documents under all directories of the first module content folder, filtering empty directories without entity documents, matching corresponding eCTD specifications for each entity document in sequence to generate leaf tags, checking by using md5, and adding each attribute.
4. The eCTD conversion method for NeeS electronic documents according to claim 3, wherein: further comprising:
s5, copying an eCTD format sequence file as an original version sequence file to be replaced, identifying national regulation version information in the original version sequence file to be replaced, establishing a blank directory of a target regulation file system by using a version format of a target regulation, wherein the target regulation file system comprises a tree-shaped parent-child node relation, reserving the original version sequence file to be replaced, identifying the original version file system, and establishing one-to-one file mapping of the original version file system and the target regulation file system; and extracting the entity files in the original version sequence files from the original version file system, rebinding the entity files to the target rule file system, and generating a new file path.
5. An eCTD conversion method for a NeeS electronic document according to claim 4, wherein said step S5 further comprises:
s51, identifying national regulation version information in an original version sequence file to be replaced, wherein the national regulation version information comprises a national number and a version number, and the original version sequence file comprises a skeleton file and a plurality of module content folders;
s52, establishing a blank directory of a target rule file system by using a version format of a target rule, wherein the target rule file system comprises a tree parent-child node relationship, reserving an original version sequence file to be converted, identifying the original version file system, and establishing one-to-one file mapping between the original version file system and the target rule file system;
and S53, after the file mapping is finished, extracting the entity file in the original version sequence file from the original version file system, binding the entity file to the target rule file system again, and generating a new file path.
6. An eCTD conversion system for a NeeS electronic document, comprising:
the classification module is used for selecting countries needing conversion, downloading corresponding national rule version templates, establishing and naming original folders according to preset definition rules, and respectively placing the NeeS electronic documents to be converted into the original folders according to functions and categories;
the file creating module is used for entering a first module content folder directory of a national regulation template, analyzing the national and regulation versions according to rules and creating regional backbone files;
the information supplementing module is used for searching an envelope information rule directory in the first module content folder, analyzing a document in the envelope directory and supplementing the document to an envelope information filling position in the regional backbone file;
and the file generation module is used for respectively searching 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 ingredients, products, auxiliary materials, indications and research information specific directories, and generating an eCTD format sequence file of a target national regulation version.
7. An eCTD conversion system for NeeS electronic documents as claimed in claim 6, wherein: the original folders comprise a regional regulation folder, an active ingredient folder, a product folder, an auxiliary material folder, a research folder and an indication folder.
8. An eCTD conversion system for NeeS electronic documents as claimed in claim 7, wherein: the information supplementing module is also configured to find paths in which entity documents are stored under all directories of the first module content folder, filter empty directories without the entity documents, sequentially match corresponding eCTD specifications for each entity document to generate leaf tags, check by md5 and add each attribute.
9. An eCTD conversion apparatus for a NeeS electronic document, comprising a memory, a processor, and a computer program stored in the memory and executable on the processor, wherein: the processor when executing the computer program realizes the steps of the method according to any of claims 1-5.
10. A computer-readable storage medium storing a computer program, characterized in that: the computer program realizing the steps of the method according to any of claims 1-5 when executed by a processor.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN116955300A (en) * | 2023-09-18 | 2023-10-27 | 云南瀚文科技有限公司 | File generation method and system based on label technology |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN116955300A (en) * | 2023-09-18 | 2023-10-27 | 云南瀚文科技有限公司 | File generation method and system based on label technology |
| CN116955300B (en) * | 2023-09-18 | 2023-11-28 | 云南瀚文科技有限公司 | File generation method and system based on label technology |
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