eCTD Editor® - user guide

Creating eCTD submission is now easier than you would ever expect.

Obsah:

Working with Medicinal Products

Creating a Medicinal Product

First, you need to create a medicinal product folder for which you will be creating an eCTD submission. To start on this icon:

A dialog window appears.

Use the “Product Name” box to enter the name of the product.

This information is not part of the export will not be sent to the regulatory authority, however the specification criteria allow only some characters. The software will verify if you have used allowed characters immediately.

In the „Local Module“ box specify the module 1. This selection is decisive for all subsequent sequences. Currently, you can choose from:

  • Canada
  • EU
  • USA
  • Switzerland

In case of an EU option, you must also choose the subdirectories that are repeated in the M1:

These subdirectories can later be created individually, updated, or added to where the specification allows. Press OK. A new product will appear in the product folder tree just below the toolbar.

The created product will be added to the grid of products as a new selected record.

Changing the Product’s Name

To rename the product, select its name in the directory tree on the left. Rename it in the Properties panel of the selected directory:

Product renaming

The product can be renamed if no submission has been generated and if you have selected its name in the tree on the left. The form with the cell for its name is displayed in the right part of the Properties panel.

Deleting the Medicinal Product

The medicinal product can be deleted only if no submission has been exported. To delete it use this icon:

In case any submission has been already exported it is necessary first delete each sequence.

Finding a Medicinal Product

In the left part of the screen there is the “Queries” panel, which is implicitly hidden. Click the vertical button “Queries”, two folders you can click on appear:

  • Products with unsent submission - products that have at least one non-exported (published) sequence appear
  • All products - all products appear

Folders for products filtering

The search result is displayed in the table. Product records in the table can be sorted by individual columns. It is also possible to create filters.

Working with Sequences

Creating a New Sequence

A new sequence can be created by this icon:

Adding of a new sequence

The sequence can be created only if the previous sequence has been exported. To create a new sequence you need to select the product.

Deleting a Sequence

To delete the sequence use this icon:

If a sequence is selected and if it is the last sequence of the product, and if there is no generated export for that sequence, then the icon is available in the menu and the sequence can be deleted.

Working with EU Envelope, USA Administrative part, Canada Admin Information part

M1 EU Envelope

The envelope can be created when you choose the EU folder in the tree.

Creating of an EU envelope

In the Properties panel an Add Envelope button appears.

EU envolope form fields

The individual fields are provided with help. Dropdown controls also include explanatory notes for abbreviations. The user does not need to search for the help.

Formulář zobrazuje o každé kolonce nápovědu z poslední verze specifikace. Uživatel nemusí příslušnou nápovědu dohledávat. Roletky obsahují ke každé volbě komentáře.

Some fields allow you to enter multiple values (Invented Names, Inns, Tracking). To add any value to the list press the Add button. To remove any value press the Remove button. The Remove button is available only if the value is selected.

More envelopes can be created depending on the number of countries. All are saved at once by pressing the OK button. Incorrectly filled columns are indicated in red and error is described.

EU envolope form fields

The box „Related sequence“ states the number of sequence which started any regulatory activity, e.g. initial variation application. In case of the first sequence of the regulatory activity, e.g. variation application, the number should be same as the number of the sequence which is created.

M1 USA Administrative Part

The Administrative part of the US FDA specification is displayed if you select the US folder.

Creating of a US FDA admininstrative part

The Administrative part must contain at least one contact and at least one application.

Contacts

Add a new contact using the Add Contact button.

Deletion is done using the Drop Contact button. A deleted contact must be selected beforehand.

You can enter multiple emails and more phones for a contact. Use the Add Email and Add Telephone Number buttons.

Deletion of e-mail or phone number is done using the Drop Email or Drop Telephone Number buttons. A deleted contact must be selected beforehand.

Adding of an email to a contact person

Application

Add a new application using the Add Application button.

Deletion is done using the Drop Application button. A deleted application must be selected beforehand.

Usually one sequence contains only one application.

You can also enter multiple applications. This allows you to create group submissions. In the case of group submissions the Containing Files field must be marked with one application line. This is the sequence that contains the files. The other fields are only a reference to other medicinal products and in this case the form requires to specify which other medicinal products belongs to the sequence.

The structure of the form varies according to which choices are selected in the individual dropdown controls.

The meaning of the fields is given by the help - see the Submission Id field in the image. This field has the same meaning as the Related Sequence field in the EU envelope.

Adding and application

All fields are provided with help.

Working with Folders

Creating a New Folder

In certain places of the eCTD structure the technical specification allows adding a new folder. If the creation of a new subfolder is possible the relevant icon in the menu appears

The dialog for addition of new folder looks as follows:

Přidání nové složky

If you then choose the dialog the Properties panel may contain more columns for inserting additional information:

Properties of a folder - attribute fields

Deleting a Folder

To delete a folder click the icon:

The folder can be deleted only if this folder was previously created by the user and if the sequence has not been exported yet.

Working with Documenents

Uploading a Document

If the conditions for document upload are met:

  • the sequence is not exported,
  • a folder allows document upload,
  • specification content type allows more documents of this type to be uploaded or this is the first document of that content type

the icon for upload appears:

This icon allows you to add a document. When clicked a dialog box appears, which allows you to select a file using the Browse button, or drag by the mouse to a gray rectangle, as shown in the figure:

The software allows to upload only documents complaining with specification or which can be converted accordingly (MS Office).

After uploading the document the software checks the document name. If the only one name is possible the document is renamed.

If the multiple names are possible or the name is not pre-defined the software deletes it and provides you help to choose a right name of the document.

The dialog also includes these fields:

  • Element Type - Folders typically allow you to paste multiple content types. You must select the one that corresponds to the inserted document, see below.

Selection of a content type

  • Operation - When you create the first submission the only possible action is new. In other cases also choices as append, replace, delete are also possible. After selecting “append”, “replace“ or “delete” the dialogue will display also documents from previous submissions that can be – according to the type of action - used:

Selection of an operation type

  • Modified File - - A list of documents from previous submissions which have not been replaced or deleted yet. The software ensures that a document that was removed in the previous submission could not be replaced in the following submission, etc. The “File” attribute includes a reference and enables you to open a relevant document from the previous submission so you are absolutely certain which document you are going to modify.
  • Other attributes (Substance, Manufacturer etc.) - For some documents the specification prescribes the obligation to record additional data. Without inserting the values of these attributes it is not possible to save the document.

Product Name, Dosageform, Manufacturer fields

Values of these attributes can be updated later on as long as the submission has not been generated. All you need to do is to select the relevant document record. The form for doing this is in the Properties panel.

Updating of attributes such as Product Name, Dosageform etc

Deleting a Document

If no submission has been generated yet the document can be deleted from the folder with this icon as long as it has been selected in the directory folder panel.

Deleting of a document

Submission Validation

The software allows you to validate the sequence. In addition to internal validation any other external validators can be used.

The program checks almost all specification rules of an eCTD submission at the moment when the submission is being created. However, as not all these rules can be checked immediately, it is necessary to carry out a final validation of each submission.

You can validate the sequence by click on this icon:

The resulting validation protocol looks like this:

The validation report - result of validation

It is not necessary to search for errors in the list of all criteria. All you need to do is to use the Show Errors Only button:

The list of validation errors

The error message says that submission misses the envelope data.

As soon as the envelope is created, the submission validation succeeds.

Validation result - pass fail criteria are fullfiled

Exporting Sequence

eCTD Format

If the sequence is valid the submission can be exported using this icon:

The software starts conversion of MS Word documents into the pdf format. The software converts pdf files with version lower then 1.3 to a new one. The editor also checks html links and does many other things. The software then records the sequence and offers it for downloading.

Deleting eCTD export

Once the sequence has been exported the submission cannot be changed. But you can delete the exported sequence using this icon:

It is possible to delete only the export of the last sequence. It is neccesary to delete export carefuly and only in case it has not been sent to regulatory authority.

NeeS Format

In case the sequence is exported to eCTD format it is possible to export it to NeeS format using this icon:

Deleting NeeS Export

If export in NeeS format has been created, it is possible to delete it using this icon: