Ennov InSight 7.3.4 Release Notes

The Release Notes contain information about updated files, new functionality, resolved issues, and any open issues or workarounds in this release of Ennov InSight 7.3.4.

The details in these Release Notes supersede all similar details that appear anywhere else in this release of the product or its other documentation.

eCTD 4.0

Ennov InSight 7.3.4 introduces the following enhancements for eCTD 4.0:

  • In the forward compatibility assembly, the functions on leafs will be the same as in eCTD 3.2.
  • Leafs migrated with forward compatibility are published with a different leaf reference format.
  • For forward compatibility, eCTD 4.0 leaf now includes the reference to the eCTD 3.2 leaf.
  • Envelope field values and sender-defined keywords are automatically migrated from the submitted 3.2 assembly to the working 4.0 assembly.
  • The sender-defined keywords are created from the text values in metadata.
  • The envelope fields are populated automatically in some cases.
  • After making any changes to the Sender-defined Keywords, the Sender-defined Keywords tab now remains available on the Application Attributes page. This enhancement eliminates the need to navigate to the Sender-defined Keywords tab.
  • Publishing of JP eCTD 4.0 submissions is improved in this release.
  • When a whole module node is added and the Create eCTD Wizard is used, the repeatable folders are no longer sorted. The sub-nodes of repeatable folders, however, are sorted.
  • In the Create eCTD Wizard for eCTD 4.0, the fields on the Set Submission Metadata page are now combined into groups which can be expanded and collapsed so that it is easy to focus on the specific set of metadata and work with many data at the same time.

Regulatory Updates

Ennov InSight 7.3.4 now introduces Ukraine (UA) v1.0 submissions:

For more information about new UA values, extensions, and rules, see

  • Ennov InSight Data Migration 7.3 > Ennov InSight 7.3.4 Updates
  • Ennov InSight Administration 7.3 > eCTD Codes > eCTD Codes for Filing Types > eCTD Filing Types for UA v1.0
  • Ennov InSight Administration 7.3 > eCTD Codes > eCTD Codes for Procedure Types
  • Ennov InSight Administration 7.3 > eCTD Codes > eCTD Codes for Country Values T-Z
  • Ennov InSight Administration 7.3 > Assembly XML Specification > Extensions > Groups of Extensions by Version and Country
  • Ennov InSight Administration 7.3 > Assembly XML Specification > Extensions > Folder Extensions > envelope-ua > Envelope-ua v1.0
  • Ennov InSight Administration 7.3 > Administrative Activities > Manage eCTD and eCTD 4.0 Templates > eCTD Templates
  • Ennov InSight Publishing 7.3 > Use eCTD Templates > eCTD and NeeS Template Files
  • Ennov InSight Publishing 7.3 > Use eCTD Templates > Mapped eCTD Template Profiles
  • Ennov InSight Publishing 7.3 > Extended Attributes Name, Type, and Version
  • Ennov InSight Publishing 7.3 > Submissions > Create eCTD Wizard > Ukraine-v1.0
  • Ennov InSight Publishing 7.3 > Extension Type and Usage > Extension Type: Regional Folders > Ukraine

Ennov InSight 7.3.4 now introduces Australia (AU) v3.2 submissions:

For more information about new AU values, extensions, and rules, see:

  • Ennov InSight Data Migration 7.3 > Ennov InSight 7.3.4 Updates
  • Ennov InSight Administration 7.3 > Assembly XML Specification > Extensions > Groups of Extensions by Version and Country
  • Ennov InSight Administration 7.3 > Assembly XML Specification > Extensions > Folder Extensions > m1-au v3.2
  • Ennov InSight Administration 7.3 > Administrative Activities > Import eCTD Applications > Prepare for Bulk eCTD Import
  • Ennov InSight Administration 7.3 > Administrative Activities > Manage eCTD and eCTD 4.0 Templates > eCTD Templates
  • Ennov InSight Administration 7.3 > eCTD Codes > eCTD Codes for Filing Types > AU v3.2
  • Ennov InSight Publishing 7.3 > Use eCTD Templates > eCTD and NeeS Template Files
  • Ennov InSight Publishing 7.3 > Extended Attributes Name, Type, and Version
  • Ennov InSight Publishing 7.3 > Use eCTD Templates > Mapped eCTD Template Profiles
  • Ennov InSight Publishing 7.3 > Extension Type and Usage > Extension Type: Regional Folders > Australia

Ennov InSight 7.3.4 now supports the Centralized Procedure type for the West African Health Organization (WAHO), in preparation for future implementation for WAHO submissions:

For more information about new WAHO values, extensions, and rules, see:

  • Ennov InSight Data Migration 7.3 > Ennov InSight 7.3.4 Updates
  • Ennov InSight 7.3 Administration > eCTD Codes > eCTD Codes for Procedure Types > WAHO
  • Ennov InSight 7.3 Administration > Application Maintenance > Application Maintenance: Application Values > Procedure Type Values
  • Ennov InSight 7.3 Registration > Applications
  • Ennov InSight 7.3 Registration > Applications > Create Application Wizard > CTA, CTR and IND Application
  • Ennov InSight 7.3 Registration > Applications > Create Application Wizard > CTA, CTR and IND Application > Create a CTA, CTR or an IND Application
  • Ennov InSight 7.3 Registration > Global Project Planning > Create a Project > New Applications Package Set Registration Project > Create a New Applications Package Set Registration Project
  • Ennov InSight 7.3 Registration > Global Project Planning > Create Product Registrations for Project Events
  • Ennov InSight 7.3 Registration > Applications > Copy Applications
  • Ennov InSight 7.3 Registration > Applications > Application Countries > Remove Application Countries
  • Ennov InSight 7.3 Registration > Events > Event-Country Statuses, Actual Dates, Projected Dates, and Lead Times
  • Ennov InSight 7.3 Publisher > Ennov InSight Publishing
  • Ennov InSight 7.3 Publisher > Create Submission Wizard > Major Update Submission
  • Ennov InSight 7.3 Publisher > Create Submission Wizard > Initial Application Submission
  • Ennov InSight 7.3 Publisher > Create Submission Wizard > Initial Application Submission > Initial Application Submission Attributes
  • Ennov InSight 7.3 Publisher > Create Submission Wizard > Major Update Submission
  • Ennov InSight 7.3 Publisher > Create Submission Wizard > Amendment Submission > Amendment Submission Attributes

Common Enhancements

For better search and selection capability, an improved version of Product Selection widget is included in the Create Submission and GPP wizards. For details, see the Product Selection section under Wizard Sections Updated: Ennov InSight 7.3.4.

IDMP Updates

To comply with the latest EMA IDMP implementation Guide (Chapter 2 version 2.2) and also improve the user experience, Ennov InSight now includes various updates for IDMP data capture:

  • The following fields have been added to the Phamaceutical Product Active Ingredient, Pharmaceutical Product Substance, Manufactured Item Active Ingredient, and Manufactured Item Substance entities:
    • Origin of Substance
    • Composition Grouping Description
  • Ability to create same Substance value with the Same Substance Name and Type and different Composition Grouping Description field.
  • By default, the Origin of Substance and Composition Grouping Description fields are hidden on the PDS > Active Ingredient Detail and PDS > Substance Detail pages.
  • The Manufacturing Authorisation Reference Number under Data Administration > Manufacturer is enabled for extra fields functionality.
  • It is now possible to use RMS mapping for Data Administration > File Identifier Type Values to RMS Master File Identifier Type list.
  • It is now possible to edit the Confidentiality Indicator under Data Administration > Manufacturer Values > Global Product Details.
  • The new field Required for IDMP? is now included for all PDS > Manufacturer Details.
  • The field type for Medicinal Product Names > Full Name is changed from Text field to Text area. This allows up to 4000 characters to be entered for the Medicinal Product Names > Full Name entity.
  • The Manufacturer value now displays as a concatenation of Manufacturer Name + Address Line + Country Code + (Location ID, when associated to OMS and Location ID Status when not active). For details, see Manufacturer Value section under Entity Fields, Columns and Options Updated: Ennov InSight 7.3.4.

  • For a Registration Package Set entity, the field Legal Status of Supply is moved from Registration Package Set Country to Registration Package Set.

  • Registration Package Set has been removed from the Pending Changes wizard → Change Scope drop-down field.

  • New fields have been added for IDMP Strengths and existing fields have been modified to comply with EMA's implementation guide for IDMP.

    • For more information about about the new fields added, see Presentation Strength section under Entity Fields, Columns and Options Added: Ennov InSight 7.3.4.
    • For more information on the changes made to the existing fields, see Presentation Strength and Concentration Strength sections under Entity Fields, Columns and Options Updated: Ennov InSight 7.3.4.
  • For the Package Item - MI Quantity Unit and Device Quantity Unit fields under PDS Packaging Details, values are shown from both the Unit of Presentation and Unit of Measurement Data Administration lists.
  • The hierarchy for PMSID is updated based on IDMP specification changes. In addition, the IDMP tab on the Application Attributes page is updated.
  • For all Application Procedure Types, the new field Package PMSID is included for Registration Package Set.
  • To prepare for IDMP, the Associate Term icon is available on Data Administration > Substance Values and allows SMS values to be associated.
  • For Packaging PDS Detail, the new field Parent Package is included with a logic. For more information, see Entity Fields, Columns and Options Added: Ennov InSight 7.3.4.

Publishing

When using the Remove Submissions from Lifecycle to this Sequence option to remove multiple sequences from lifecycle, the confirmation message now specifies the number of sequences that will be removed.

Registration

  • It is now possible to disassociate multiple Change Details from an Event simultaneously.

XEVMPD

  • The new option Full Product Presentation under the same Registration per each Package Set is used is now available to create a copy of the original Full Product Presentation for each Package Set selected under the same Registration. Using this option does not update the Package Description field.
  • Full Product Presentation entity
    • The Country field on Full Product Presentation has been hidden OOTB. It has also been hidden in the Copy FPP wizards.
    • The new field MAH/Organisation Transferred To is available when Authorisation Status Not Valid - Superseded by Marketing Authorisation Transfer is selected for FPP entity.
      • XEVMPD Submission Wizard is updated to include the new tag in the XML structure.
  • The Copy Full Product Presentation wizard is enhanced to copy the following fields that were not copied earlier. For details, see New in Ennov InSight 7.3.4: XEVMPD.

API

It is now possible to search by substanceReference and manufacturers fields using the API query endpoint.