With every release, we update the data model to better support evolving needs and new feature functionality. With this release, we’ve added the following components to the Regulatory data model. These data model updates are automatically included in all Regulatory Vaults, but Admins must make configuration changes to make them available. For information on feature functionality, see What’s New in 20R2.
Added the following components to support the Submission Join Filters feature:
- Added the Application (
application__v) field to the following objects:- Submission Active Substance (
submission_active_substance__rim) - Submission Clinical Study (
submission_clinical_study__rim) - Submission Country (
submission_country__rim) - Submission Inactive Ingredient (
submission_inactive_ingredient__rim) - Submission Indication (
submission_indication__rim) - Submission Language (
submission_language__rim) - Submission Nonclinical Study (
submission_nonclinical_study__rim) - Submission Packaging (
submission_packaging__rim) - Submission Pharmaceutical Product (
submission_pharmaceutical_product__rim) - Submission Product Classification (
submission_product_classification__v) - Submission Regulatory Objective (
submission_regulatory_objective__v)
- Submission Active Substance (
Note: By adding this field to the Submission Regulatory Objective object, we are converting this object from a simple join to a complex join object. When creating a Submission record from the related object section on the Regulatory Objective object record detail page, and vice versa, users will continue to see the Add button instead of a Create button because the Relate Multiple Records setting will be enabled by default as part of this change. In the related object grids on the object record detail pages, users will now see the Submission Regulatory Objective Name column. System-managed naming is also enabled on the Submission Regulatory Objective object. Your organization can adjust the naming pattern if desired.
Added the following components to support the GCC v1.5 (DTD 1.1) eCTD feature:
- Added the Related Application (
related_application__v) object
Added the following components to support the Manage Registered Details for Medical Devices feature:
- Added the Regulatory Objective (
regulatory_objective__v) field to the following objects:- Registered Product Classification (
registered_product_classification__v) - Registered Product Characteristic (
registered_product_characteristic__v) - Registered Packaging Characteristic (
registered_packaging_characteristic__v)
- Registered Product Classification (
Added the following components to support the TH v1.0 eCTD Publishing feature:
- Added the Licensee Type (
licensee_type__v) field to the Application (application__v) object.
Added the following components to support the South Africa eCTD DTD 2.1 Publishing & Validation feature:
- Added the Submission Efficacy Data Type (
sub_eff_data_type__v) value to the Controlled Vocabulary Type (controlled_vocabulary_type__rim) picklist.
Added the following components to support the Merge PDF Error Handling feature:
- Added the Exclude from Post Processing on Failure (
exclude_from_post_processing_on_failure__v) field on the Publishing Validation Criteria (publishing_validation_criteria__v) object.
Added the following components to support the Registration History View feature:
- Added the Registered Markets (
registered_markets__v) field to the Product (drug_product__v). - Added the Registered Markets (
registered_markets__v) picklist.
Added the following components to support the Verification of Registration Data feature:
- Added the Unverified Registration Data (
unverified_registration_data__v) object. This object is added to all RIM application Vaults but is only unlocked in Registrations Vaults. This object includes the following object types:- Unverified Data (
unverified_registration_data__v.unverified_data__v) - Summary of Changes (
unverified_registration_data__v.summary_of_changes__v)
- Unverified Data (
- Added the Registration Data Verification (
registration_data_verification__v) object workflows with notifications. - Added the Action Type (
action_type__v) picklist. - Added the Impacted Record (
impacted_record__v) picklist.
Added the following components to support the Auto-Match Previously Matched Documents to Multiple Submissions Related to the Same Application feature:
- Added the Include Previously Matched Documents (
include_previously_matched_documents__v) field to the Submission (submission__v) object.
Added the following components to support the IDMP Phase 1: Algorithms feature:
- Added the IDMP Product Data Submission (
idmp_product_data_submission__v) object. - Added the IDMP Element (
idmp_element__v) object. - Added the IDMP Attachment (
idmp_attachment__v) object. - Added the IDMP Classification System (
idmp_classification_system__v) object with object types:- ATC Code (
idmp_classification_system__v.anatomical_therapeutic_classification__v) - Legal Basis (
idmp_classification_system__v.legal_basis__v) - Medicinal Product Category (
idmp_classification_system__v.medicinal_product_category__v) - Paediatric Use (
idmp_classification_system__v.paediatric_use__v) - XEVMPD Product Type Information (
idmp_classification_system__v.xevmpd_product_type_information__v)
- ATC Code (
- Added the IDMP Master File (
idmp_master_file__v) object. - Added the IDMP Medicinal Product Element (
idmp_medicinal_product_element__v) object. - Added the IDMP Medicinal Product Full Name (
idmp_medicinal_product_full_name__v) object. - Added the IDMP Name Part (
idmp_name_part__v) object. - Added the IDMP Pharmaceutical Product Element (
idmp_pharmaceutical_product_element__v) object. - Added the IDMP Product Cross Reference (
idmp_product_cross_reference__v) object. - Added the IDMP Regulatory Authorisation (
idmp_regulatory_authorisation__v) object with object type:- Orphan Designation (
idmp_regulatory_authorisation__v.orphan_designation__v)
- Orphan Designation (
- Added the IDMP Route of Administration (
idmp_route_of_administration__v) object. - Added the Product Cross Reference (
product_cross_reference__v) object. - Added the Medical Device Type (
medical_device_type__v) field to the Administered Product (administered_product__rim) object. - Added the Domain (
domain__v) field to the Application (application__v) object. - Added the following fields to the Classification System (
classification_system__rim) object:- ATC (
atc__v); also added this field to the ATC object type - Medicinal Product Category (
medicinal_product_category__v) - Paediatric Use Indication (
paediatric_use_indication__v); also added this field to the Paediatric Use object type
- ATC (
- Added the Medicinal Product Category (
classification_system__rim.medicinal_product_category__v) object type to the Classification System (classification_system__rim) object. - Added the Contact Subtype (
contact_subtype__v) field to the Contact (contact__rim) object. - Added the SPOR Referential ID (
spor_referential_id__v) field to the Language (language__rim) object. - Added the following fields to the Medicinal Product (
medicinal_product__rim) object:- EURD ID (
eurd_id__v) - Authorisation Type (
authorisation_type__v) - PMS ID (
pms_id__v)
- EURD ID (
- Added the Name Part Type (IDMP) (
name_part_type_idmp__v) field to the Medicinal Product Part Name (medicinal_product_name_part__rim) object. - Added the Master File Type (
master_file_type__v) field to the Organization (organization__rim) object. - Added the Orphan Designation (
orphan_designation__v) field to the Registered Indication (registered_indication__rim) object. - Added the Regulatory Authorisation (
regulatory_authorisation__v) object with object type:- Orphan Designation (
regulatory_authorisation__v.orphan_designation__v)
- Orphan Designation (
- Added new values to the Controlled Vocabulary Type (
controlled_vocabulary_type__rim) picklist. - Added the following shared document fields:
- IDMP Document Type (
idmp_document_type__v) - IDMP Effective Date (
idmp_effective_date__v) - IDMP File Type (
idmp_file_type__v) - IDMP PMS ID (
idmp_pms_id__v)
- IDMP Document Type (
Added the following components to support the Submission Import from Vault File Manager feature:
- Added new picklist values to the Dossier Status (
dossier_status__v) picklist. - Added the Upload Package ID (
upload_package_id__v) field on Submission (submission__v) object
In addition to the changes supporting new features, we added the following components:
- Added a new field to the Product (
drug_product__v) object to indicate the markets where the product is registered. This field can be leveraged for reporting when one market wishes to see data related to all registrations globally after it is approved in a key market, such as the EU. - Added the Country Language (
country_language__v) object. - Added the Product Type Jurisdiction (
constraint__rim.product_type_jurisdiction__v) object type to the Constraint (constraint__v) object. - Added the Organization (
organization__v) field to the Health Authority (health_authority__rim) object. - Added the Product Type Jurisdiction (
product_type_jurisdiction__v) value to the Constraint Scope (constraint_scope__v) picklist. - Updated the Description on the Correspondence Event (
correspondence_event__v) object.
In this release, we have also enabled numerous attributes, such as Required, System Managed Name, and more, on many standard objects and fields. These attributes allow organizations to configure these components according to their business requirements without needing to contact Veeva Support or Product Management to make these configuration changes. In order to utilize these newly-enabled attributes, Admins must perform the desired configuration to make them available for users.