23R3 Data Model Changes: Regulatory

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 23R3.

• Added the Parameter (parameter__v) field to the Publishing Validation Criteria (publishing_validation_criteria__v) object to support the Configurable Validation Rules feature.

• Added the following components for the Support for Certification Bodies in Multiple Markets for Medical Devices Applications feature:
  • Added the following to the Constraint (constraint__rim) object:
    • Organization (organization__v) field
    • Region Specific Entry (region_specific_entry__v) object type
  • Added the Certification Body (certification_body__v) picklist value to the Constraint Scope (constraint_scope__v) picklist
  • Added the Certification Body (certification_body__v) field to the Registration (registration__rim) object
• Added or updated the following components for the UDI Data Model Updates for EU and US feature:
  • Added the following picklists:
    • PI Types (pi_types__v)
    • Sterilization Methods (sterilization_methods__v)
    • Non-Medical Purpose (nonmedical_purpose__v)
  • Added the Not Evaluated (not_evaluated__v) picklist value to the MRI Safety Status (mri_safety_status__v) picklist
  • Added the Package Type (package_type__v) field to the Packaging (packaging__rim) object
  • Added the UDI Publish Date (udi_publish_date__v) field to the Registered Packaged Product (registered_packaged_medicinal_product__v) object
  • Added the UDI Attribute Set (udi_attribute_set__v) object, as well as page layouts for its object types
  • Added the Product UDI Attribute Set (product_udi_attribute_set__v) object.
  • Added the Packaging UDI Attribute Set (packaging_udi_attribute_set__v) object
  • To the below objects, added the Basic UDI Attributes (basic_udi_attributes__v) object type, as well as object fields Basic UDI Attribute Set (basic_udi_attribute_set__v), Autoname Calculation (autoname_calculation__v), Basic UDI-DI (basic_udidi__v), and Medical Device Type (medical_device_type__v). Note: Only items marked with a * include the Medical Device Type field.
    • Registered Product Characteristic (registered_product_characteristic__v)*
    • Event Product Characteristic (event_product_characteristic__v)
    • Application Product Characteristic (application_product_characteristic__v)
    • Reg Objective Product Characteristic (reg_objective_product_characteristic__v)
    • Submission Product Characteristic (submission_product_characteristic__v)
  • To the below objects, added the UDI Attributes (udi_attributes__v) object type, as well as object fields UDI Attribute Set (udi_attribute_set__v), Autoname Calculation (autoname_calculation__v), UDI-DI (udidi__v), Basic UDI-DI (basic_udidi__v), and Medical Device Type (medical_device_type__v). Note: Only items marked with a * include the Medical Device Type field.
    • Registered Packaging Characteristic (registered_packaging_characteristic__v)*
    • Event Packaging Characteristic (event_packaging_characteristic__v)
    • Application Packaging Characteristic (application_packaging_characteristic__v)
    • Reg Objective Packaging Characteristic (reg_objective_packaging_characteristic__v)
    • Submission Packaging Characteristic (submission_packaging_characteristic__v)
  • To the below objects, added the UDI Clinical Size (udi_clinical_size__v) object type, as well as object fields Product (product__v), Product Variant (product_variant__v), Global Size (global_size__v), and Local Size (local_size__v). Note: Only items marked with a * include the Local Size field.
    • Registered Packaging Characteristic (registered_packaging_characteristic__v)*
    • Event Packaging Characteristic (event_packaging_characteristic__v)
    • Application Packaging Characteristic (application_packaging_characteristic__v)*
    • Reg Objective Packaging Characteristic (reg_objective_packaging_characteristic__v)*
    • Submission Packaging Characteristic (submission_packaging_characteristic__v)*
  • Added the Packaging (packaging__v) field to the following objects:
    • Product Nomenclature Code (product_classification__v)
    • Registered Nomenclature Code (registered_product_classification__v)
    • Event Nomenclature Code (event_product_classification__v)
    • Application Nomenclature Code (application_product_classification__v)
    • Regulatory Objective Nomenclature Code (reg_objective_product_classification__v)
    • Submission Nomenclature Code (submission_product_classification__v)
  • Added the Packaging Authorization (packaging_authorization__v) object.
  • Added the Packaging (packaging__v) field to the following objects:
    • Registered Authorization (registered_authorization__v)
    • Event Authorization (event_authorization__v)
    • Application Authorization (application_authorization__v)
    • Regulatory Objective Authorization (regulatory_objective_authorization__v)
    • Submission Authorization (submission_authorization__v)
  • Added the Alternative Country Code (alternative_country_code__v) field to the Country (country__v) object
• In all RIM Vaults, increased the field length of the Risk Class (risk_class__v) field within the Health Authority Code (health_authority_code__v) object (to 25 characters)
• In all RIM Vaults, enabled the Values must be unique configuration for the below object fields (identified first by object):
  • Application (application__v) object: Folder Name (folder_name__v)
  • Organization (organization__rim) object: DUNS Number (duns_number__v)
  • Application Pharmaceutical Form (application_pharmaceutical_form__v) object: Pharmaceutical Form (pharmaceutical_form__v)
  • Submission Pharmaceutical Form (submission_pharmaceutical_form__v) object: Pharmaceutical Form (pharmaceutical_form__v)
  • Event Pharmaceutical Form (event_pharmaceutical_form__v) object: Pharmaceutical Form (pharmaceutical_form__v)
  • Organization (organization__rim) object: Pharmaceutical Form (spor_location_id__v)
• In all RIM Vaults, enabled the User must always enter a value (required) configuration for the below object fields (identified first by object):
  • Packaging Container (packaging_container__rim) object:
    • Quantity (quantity__rim)
    • Quantity Unit (quantity_unit__v)
  • Packaging Container Component (packaging_container_component__rim) object: Quantity (quantity__rim)
  • Packaging Product Variant (packaging_product_detail__rim) object:
    • Quantity (quantity__rim)
    • Quantity Unit (quantity_unit__v)
  • Packaging Shelf Life or Condition (packaging_shelf_life__rim) object:
    • Storage Condition (storage_condition__v)
    • Product (product__v)
    • Product Variant (product_variant__v)
  • Regulatory Objective Packaging (regulatory_objective_packaging__v) object: Product Variant (product_detail__v)
  • Submission Packaging (submission_packaging__rim) object: Product Variant (product_detail__rim)
  • Event Packaging (event_packaging__rim) object: Product Variant (product_detail__rim)
  • Activity (activity__rim) object: Planned Completion Date (planned_completion_date__rim)
  • Data Carrier (data_carrier__rim) object: Identifier (identifier__rim) field
  • Medicinal Product Registration (medicinal_product_registration__v) object: Medicinal Product Full Name (medicinal_product_full_name__v)
  • Activity Labeling Concept (activity_labeling_concept__v) object: Name (name__v) This data model change was documented in error.
• In all RIM Vaults, enabled the System manages field value (read-only) configuration for the Name (name__v) field in the following objects:
  • Activity Labeling Concept (activity_labeling_concept__v)
  • Product (drug_product__v)
• In all RIM Vaults, enabled Admins to update the Picklist Status Value for the listed values in the following picklists:
  • Controlled Vocabulary Type (controlled_vocabulary_type__rim) picklist values: 
    • UDI Submission Type (udi_submission_type__v)
    • Record Status (record_status__v)
  • Identifier Type (identifier_type__v) picklist values:
    • Packaging UDI-DI (packaging_udidi__v)
    • Direct Mark UDI-DI (direct_mark_udidi__v)
    • Unit of Use UDI-DI (unit_of_use_udidi__v)
    • Secondary UDI-DI (secondary_udidi__v)
    • Primary UDI-DI (primary_udidi__v)
    • Catalog Number (catalog_number__v)
    • Model or Version (model_or_version__v)
  • Safety Category (safety_category__v) picklist values:
    • Class I (class_i__v)
    • Class II (class_ii__v)
    • Class III (class_iii__v)
    • Class IV (class_iv__v)
• For the Wizard Support for Full Indication Text & Orphan Designation feature, added the below fields to the Event Indication (event_indication__rim) and Submission Indication (submission_indication__rim) objects:
  • Full Indication Text (full_indication_text__v)
  • Orphan Designation (orphan_designation__v)
• To support the Submission Wizard Support for Registrations Fields feature, updated field configuration in all RIM Vaults such that when the Enable Application Relationships setting is enabled, Vault clears any default values and locks the field configuration (preventing any additional Admin configuration). This is also the new default behavior in all Vaults where the setting is not yet enabled. Note: Fields marked with a * are also new fields added in this release.
  • Use for Registrations (use_for_registrations__v) field in the following objects:
    • Regulatory Objective Active Substance (regulatory_objective_active_substance__v)
    • Regulatory Objective Clinical Study (regulatory_objective_clinical_study__v)
    • Regulatory Objective Inactive Ingredient (regulatory_objective_inactive_ingredient__v)
    • Regulatory Objective Indication (regulatory_objective_indication__v)
    • Regulatory Objective Nonclinical Study (regulatory_objective_nonclinical_study__v)
    • Regulatory Objective Product (regulatory_objective_drug_product__v)
    • Submission Active Substance (submission_active_substance__rim)
    • Submission Clinical Study (submission_clinical_study__rim)
    • Submission Inactive Ingredient (submission_inactive_ingredient__rim)
    • Submission Indication (submission_indication__rim)
    • Submission Nonclinical Study (submission_nonclinical_study__rim)
    • Submission Product (submission_pharmaceutical_product__rim)
  • Species (species__v) field in the following objects:
    • Submission Product (submission_pharmaceutical_product__rim)
    • Regulatory Objective Product (regulatory_objective_drug_product__v)
  • Withdrawal Period (withdrawal_period__v) field in the following objects:
    • Submission Product (submission_pharmaceutical_product__rim)
    • Regulatory Objective Product (regulatory_objective_drug_product__v)
  • Distributor Type (distributor_type__v) field in the following objects:
    • Submission Organization (submission_site_organization__v)
    • Regulatory Objective Organization (regulatory_objective_site_organization__v)
  • The below fields in the Submission Product (submission_pharmaceutical_product__rim) and Regulatory Objective Product (regulatory_objective_drug_product__v) objects:
    • Co-Packaged or Integral Device (copackaged_or_integral_device__v)
    • Drug Product (device_drug_product__v)
    • Drug Product Variant (device_drug_product_variant__v_)
  • The below fields in the Submission Indication (submission_indication__rim) object:
    • Full Indication Text (full_indication_text__v)
    • Orphan Designation (orphan_designation__v)
  • The Regulatory Text Translation (regulatory_text_translation__v) field in the below objects.
    • Submission Regulatory Text (submission_regulatory_text__v)
    • Regulatory Objective Regulatory Text (regulatory_objective_regulatory_text__v)
  • In the Submission Product Characteristic (submission_product_characteristic__v) object: Basic UDI Attribute Set (basic_udi_attribute_set__v) field
  • The below fields in the Submission Packaging Characteristic (submission_packaging_characteristic__v) object:
    • UDI Attribute Set (udi_attribute_set__v)
    • Product (product__v)
    • Product Variant (product_variant__v)
    • Global Size (global_size__v)
    • Local Size (local_size__v)
  • In the Submission Nomenclature Code (submission_product_classification__v) object: Packaging (packaging__v) field
  • In the Submission Authorization (submission_authorization__v) object: the Packaging (packaging__v) field
  • In the Reg Objective Product Characteristic (reg_objective_product_characteristic__v) object: Basic UDI Attribute Set (basic_udi_attribute_set__v) field
  • The below fields in the Reg Objective Packaging Characteristic (reg_objective_packaging_characteristic__v) object:
    • UDI Attribute Set (udi_attribute_set__v)
    • Product (product__v)
    • Product Variant (product_variant__v)
    • Global Size (global_size__v)
    • Local Size (local_size__v)
  • In the Regulatory Objective Nomenclature Code (reg_objective_product_classification__v) object: Packaging (packaging__v) field
  • In the Regulatory Objective Authorization (regulatory_objective_authorization__v) object: Packaging (packaging__v) field
• To support the Active Dossier Module 1 & Module 2 Support feature, added the 23.3 (23_3__v) picklist value to the Version Introduced (version_introduced__v) picklist.
• To support the Drug-Led Combination Product Registration Enhancements for IDMP feature, added object fields Device Product (device_drug_product__v) and Device Product Variant (device_drug_product_variant__v)*, to the following objects:
  • Event Product (event_drug_product__rim)
  • Application Product (application_pharmaceutical_product__v)
  • Submission Product (submission_pharmaceutical_product__rim)
  • Regulatory Objective Product (regulatory_objective_drug_product__v)
  • Registered Product (registered_drug_product__rim)
  • *This listing previously included the Co-Packaged or Integral Device (copackaged_or_integral_device__v) field in error. The field was released in 23R1.
• Added the following components to support the Generate Active Dossier from Event (Manual Support) feature:
  • Added the following fields to the Active Dossier Item Detail (active_dossier_item_detail__v) object*:
    • Event (event__v)
    • Activity (activity__v)
    • *This listing previously included the Active Dossier Loader (active_dossier_loader__v) object, now deferred to a later release.
  • Added the Dispatched (dispatched__v) picklist value to the Active Dossier Status (active_dossier_status__v) picklist
• In all RIM Vaults, added the Submission Date (submission_date__v) field to the Submission Country (submission_country__rim) object to support the Submission Date on Submission Country for EU MRP/DCP feature.
• In all RIM Vaults, added the following components to support the Health Authority Meeting Object feature:
  • Added the following objects:
    • Health Authority Meeting (ha_meeting__v)
    • HA Meeting Clinical Study (ha_meeting_clinical_study__v)
    • HA Meeting Commitment (ha_meeting_commitment__v)
    • HA Meeting HAQ (ha_meeting_haq__v)
    • HA Meeting Product Family (ha_meeting_product_family__v)
    • HA Meeting Regulatory Objective (ha_meeting_regulatory_objective__v)
  • Added the following picklists:
    • Meeting Type (meeting_type__v)
    • Requested By (requested_by__v)
    • Meeting Format (meeting_format__v)
  • Added the Health Authority Meeting (health_authority_meeting__v) shared document field.
  • Added the HA Meeting Lifecycle (ha_meeting_lifecycle__v) object lifecycle
• For the Support for Multiple Drug Trade Names with Translations feature, added or updated the following components:
  • Added the Language (language__v) field to the Regulatory Text (regulatory_text__v) object
  • Added the Regulatory Text Translation (regulatory_text_translation__v) field to the following relationship objects:
    • Application Regulatory Text (application_regulatory_text__v)
    • Event Regulatory Text (event_regulatory_text__v)
    • Registered Regulatory Text (registered_regulatory_text__v)
    • Regulatory Objective Regulatory Text (regulatory_objective_regulatory_text__v)
  • Added the Drug Trade Name (drug_trade_name__v) object type to the following objects:
    • Regulatory Text (regulatory_text__v)
    • Regulatory Text Translation (regulatory_text_translation__v)
    • Application Regulatory Text (application_regulatory_text__v)
    • Event Regulatory Text (event_regulatory_text__v)
    • Registered Regulatory Text (registered_regulatory_text__v)
    • Regulatory Objective Regulatory Text (regulatory_objective_regulatory_text__v)
• For the New Labeling Document Fields feature, added the following components:
  • Added the following picklists:
    • Carton or Container Label Type (carton_or_container_label_type__v)
    • Labeling Components Included (labeling_components_included__v)
  • Added the following shared document fields:
    • Carton or Container Label Type (carton_or_container_label_type__v)
    • Labeling Components Included (labeling_components_included__v)
    • Tracked Changes/Redlines (tracked_changesredlines__v)
• Added the KR (kr__v) picklist value to the HA Code Source (ha_code_source__rim) picklist to support the Publishing South Korea eCTD 1.0 feature.
• To support the Link Evaluator feature:
  • Added the Publishing Metadata (publishing_metadata__v) object
  • Added the Publishing Metadata (publishing_metadata__v) field to the Content Plan Item (edl_item__v) object and all of its object types
• To support the Automated Hyperlinking feature, added or updated the following components:
  • Added the following objects:
    • Automated Linking Rule (automated_linking_rule__v)
    • Automated Linking Group (automated_linking_group__v)
    • Automated Linking Rule Group (automated_linking_rule_group__v)
    • Automated Linking Destination Type (automated_linking_destination_type__v)
    • Automated Linking Rule Destination Type (automated_linking_rule_dest_type__v)
  • Added the Automated Linking Group (automated_linking_group__v) field to the following objects:
    • Content Plan Item (edl_item__v)
    • Content Plan Item Template (edl_item_template__v)
  • Added the following picklists:
    • Target Uniqueness Policy (target_uniqueness_policy__v)
    • Sequence Search Type (sequence_search_type__v)
    • Target Search Type (target_search_type__v)
    • Target Destination Search Type (target_destination_search_type__v)
• To support the Review & Refine Related Records feature, added the In Data Review (in_data_review_state_type__v) lifecycle state type on the Event object lifecycle (events_lifecycle__c).