21R3 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 21R3.

With this release, we’ve added the following components to the Regulatory data model to support new features:

• Added the following components to support the Label Concept Management feature:
  • New objects:
    • Activity Labeling Deviation (activity_labeling_deviation__v)
    • Labeling Concept (labeling_concept__v)
    • Labeling Deviation (labeling_deviation__v)
  • Added the following fields to the Activity (activity__rim) object:
    • Labeling Impact (labeling_impact__v)
    • Resulting Local Label (resulting_local_label__v)
  • Added the following fields to the Event (event__rim) object:
    • CCDS to be Updated (ccds_to_be_updated__v)
    • CCDS with Changes Reflected (ccds_with_changes_reflected__v)
    • Due Date (due_date__v)
    • Labeling Impact (labeling_impact__v)
    • Safety Category (safety_category__v)
    • Trigger Date (trigger_date__v)
  • Added the following fields to the Regulatory Objective (regulatory_objective__rim) object:
    • Corresponding CCDS (corresponding_ccds__v)
    • Due Date (due_date__v)
    • Labeling Impact (labeling_impact__v)
    • Resulting Local Label (resulting_local_label__v)
    • Safety Category (safety_category__v)
    • Trigger Date (trigger_date__v)
• Added the World Health Organization (WHO) (country_who__v) to the Active Dossier Item (active_dossier_item__v) object.
• Added the Use for Content Planning (use_for_content_planning__v) field to the Country Language (country_language__v) object.
• Added the following fields within the Content Plan Item (edl_item__v) and Content Plan Item Template (edl_item_template__v) objects to support the Content Plan Creation Logic Updates feature:
  • Region (region__v)
  • Lead Market Country (lead_market_country__v)
  • Language for Submission (language_for_submission__v)
• Added the Content Plan (content_plan__v) and Content Plan Item (content_plan_item__v) fields to the Active Dossier Item Detail (active_dossier_item_detail__v) object to support the Sourcing Active Dossier from Submission Content Plans feature.
• Added the following fields to the Application (application__v) object:
  • Content Plan Template (content_plan_template__v)
  • Create Node Extension (create_node_extension__v) 
  • Dossier Format (dossier_format__v)
  • Gateway Format (gateway_format__v)
  • Validation Criteria Version (validation_criteria_version__v)
  • XML ICH DTD / XSD Version (xml_ich_dtd_xsd_version__v)
  • XML Regional DTD / XSD Version (xml_reg_dtd_xsd_version__v)
  • XML STF DTD / XSD Version (xml_stf_dtd_xsd_version__v)

To support the Extend Content Plan Tokens feature, added document and object fields as follows:

• Added Output Name (output_name__v) object field to the following submission join objects:
  • Submission Product (submission_pharmaceutical_product__rim)
  • Submission Active Substance (submission_active_substance__rim)
  • Submission Inactive Ingredient (submission_inactive_ingredient__rim)
  • Submission Indication (submission_indication__rim)
  • Submission Clinical Study (submission_country__rim)
  • Submission Nonclinical Study (submission_nonclinical_study__rim)
• Added document fields:
  • eCTD Title (ectd_title__v)
  • Output Name (output_name__v)

Added the following new fields to support the Empty Section Indicator feature:

• Empty Section Indicator Update Pending (esi_update_pending__v) document field to the Submissions Archive > Structure (structure__v) document subtype
• Is Empty (is_empty__v) object field to the Submission Metadata object

Added the following fields to the Submission Metadata (submission_metadata__v) object to support the EAEU Import &Viewing R.022 XML feature:

• XML Section ID (xml_section_id__v)
• Document Creation Date (document_creation_date__v)

Added the following components to support the IDMP Data Model & Algorithm Updates feature: 

• Added the following objects:
  • IDMP Manufactured Item Description (idmp_manufactured_item_description__v)
  • IDMP Reference Strength (idmp_reference_strength__v)
  • IDMP Pack Size (idmp_pack_size__v)
  • IDMP Pharmaceutical Product Description (idmp_pharmaceutical_product__v)
• Added the following document fields:
  • IDMP Alternate ID System (idmp_alternate_id_system__v)
  • IDMP ID System (idmp_id_system__v)
• Added the following fields to the IDMP Attachment (idmp_attachment__v) object:
  • Alternate ID System (alternate_id_system__v)
  • Alternate ID System Code (alternate_id_system_code__v)
  • Alternate ID System Code Text (alternate_id_system_code_text__v)
  • Alternate ID System Term (alternate_id_system_term__v)
  • Alternate ID System Term Text (alternate_id_system_term_text__v)
  • Document Type Term (document_type_term__v)
  • Document Type Term Text (document_type_term_text__v)
  • Identifier System (identifier_system__v)
  • Identifier System Code (identifier_system_code__v)
  • Identifier System Code Text (identifier_system_code_text__v)
  • Identifier System Term (identifier_system_term__v)
  • Identifier System Term Text (identifier_system_term_text__v)
  • Language Term (language_term__v)
  • Language Term Text (language_term_text__v)
• Added the following fields to the IDMP Classification System (idmp_classification_system__v) object:
  • ATC Flag (atc_flag__v)
  • ATC Flag Text (atc_flag_text__v)
  • ATC Term (atc_term__v)
  • ATC Term Text (atc_term_text__v)
  • GMO (gmo__v)
  • GMO Text (gmo_text__v)
  • Legal Basis Term (legal_basis_term__v)
  • Legal Basis Term Text (legal_basis_term_text__v)
  • Medicinal Product Category Term (medicinal_product_category_term__v)
  • Medicinal Product Category Term Text (medicinal_product_category_term_text__v)
  • Paediatric Use Term (paediatric_use_term__v)
  • Paediatric Use Term Text (paediatric_use_term_text__v)
  • XEVMPD Product Type Term (xevmpd_product_type_term__v)
  • XEVMPD Product Type Term Text (xevmpd_product_type_term_text__v)
• Added the following fields to the IDMP Component (idmp_component__v) object:
  • Component Type Term (component_type_term__v)
  • Component Type Term Text (component_type_term_text__v)
• Added the following fields to the IDMP Component Material (idmp_component_material__v) object:
  • Material Term (material_term__v)
  • Material Term Text (material_term_text__v)
• Added the following fields to the IDMP Container (idmp_container__v) object:
  • Container Type Term (container_type_term__v)
  • Container Type Term Text (container_type_term_text__v)
• Added the Registered Packaged Medicinal Product (registered_packaged_medcinal_product__v) field to the IDMP Container Data Carrier (idmp_container_data_carrier__v) object.
• Added the following fields to the IDMP Container Material (idmp_container_material__v) object:
  • Material Term (material_term__v)
  • Material Term Text (material_term_text__v)
• Added the following fields to the IDMP Container Reference Item (idmp_container_reference_item__v) object:
  • Device (device_reference__v)
  • Device Identifier (device_identifier__v)
  • Device Identifier Text (device_identifier_text__v)
  • Device Trade Name (device_trade_name__v)
  • Device Trade Name Text (device_trade_name_text__v)
  • Device Type (device_type__v)
  • Device Type Code (device_type_code__v)
  • Device Type Code Text (device_type_code_text__v)
  • Device Type Term (device_type_term__v)
  • Device Type Term Text (device_type_term_text__v)
  • Product (product__v)
  • Product Variant (product_variant__v)
  • Quantity Unit Term (quantity_unit_term__v)
  • Quantity Unit Term Text (quantity_unit_term_text__v)
  • Registered Product (registered_product__v)
  • Registered Regulatory Text (registered_regulatory_text__v)
  • Registration (registration__v)
  • Regulatory Text (regulatory_text__v)
  • Type of Combination (type_of_combination__v)
  • Type of Combination Code (type_of_combination_code__v)
  • Type of Combination Code Text (type_of_combination_code_text__v)
  • Type of Combination Term (type_of_combination_term__v)
  • Type of Combination Term Text (type_of_combination_term_text__v)
• Added the following fields to the IDMP Ingredient Element (idmp_ingredient_element__v) object:
  • AP Active Substance Term (ap_active_substance_term__v)
  • AP Active Substance Term Text (ap_active_substance_term_text__v)
  • AP Inactive Ingredient Term (ap_inactive_ingredient_term__v)
  • AP Inactive Ingredient Term Text (ap_inactive_ingredient_term_text__v)
  • CHL Denominator Unit Term (chl_denominator_unit_term__v)
  • CHL Denominator Unit Term Text (chl_denominator_unit_term_text__v)
  • CHL Numerator Unit Term (chl_numerator_unit_term__v)
  • CHL Numerator Unit Term Text (chl_numerator_unit_term_text__v)
  • CLL Denominator Unit Term (cll_denominator_unit_term__v)
  • CLL Denominator Unit Term Text (cll_denominator_unit_term_text__v)
  • CLL Numerator Unit Term (cll_numerator_unit_term__v)
  • CLL Numerator Unit Term Text (cll_numerator_unit_term_text__v)
  • Composition Grouping Description (composition_grouping_description__v)
  • Composition Grouping Description Text (composition_grouping_description_text__v)
  • Ingredient Role Term (ingredient_role_term__v)
  • Ingredient Role Term Text (ingredient_role_term_text__v)
  • Origin of the Substance (origin_of_the_substance__v)
  • Origin of the Substance Code (origin_of_the_substance_code__v)
  • Origin of the Substance Code Text (origin_of_the_substance_code_text__v)
  • Origin of the Substance Term (origin_of_the_substance_term__v)
  • Origin of the Substance Term Text (origin_of_the_substance_term_text__v)
  • PHL Denominator Unit Term (phl_denominator_unit_term__v)
  • PHL Denominator Unit Term Text (phl_denominator_unit_term_text__v)
  • PHL Numerator Unit Term (phl_numerator_unit_term__v)
  • PHL Numerator Unit Term Text (phl_numerator_unit_term_text__v)
  • PLL Denominator Unit Term (pll_denominator_unit_term__v)
  • PLL Denominator Unit Term Text (pll_denominator_unit_term_text__v)
  • PLL Numerator Unit Term (pll_numerator_unit_term__v)
  • PLL Numerator Unit Term Text (pll_numerator_unit_term_text__v)
  • Quantity Operator (quantity_operator__v)
  • Quantity Operator Code (quantity_operator_code__v)
  • Quantity Operator Code Text (quantity_operator_code_text__v)
  • Quantity Operator Term (quantity_operator_term__v)
  • Quantity Operator Term Text (quantity_operator_term_text__v)
• Added the following fields to the IDMP Manufactured Item (idmp_manufactured_item__v) object:
  • Manufactured Dose Form Term (manufactured_dose_form_term__v)
  • Manufactured Dose Form Term Text (manufactured_dose_form_term_text__v)
  • Manufactured Item Quantity Unit Term (manufactured_item_quantity_unit_term__v)
  • Manufactured Item Quantity Unit Term Text (manuf_item_quantity_unit_term_text__v)
  • Unit of Presentation Term (unit_of_presentation_term__v)
  • Unit of Presentation Term Text (unit_of_presentation_term_text__v)
• Added the following fields to the IDMP Manufactured Item Ingredient (idmp_manufactured_ingredient_item__v) object:
  • CHL Denominator Unit Term (chl_denominator_unit_term__v)
  • CHL Denominator Unit Term Text (chl_denominator_unit_term_text__v)
  • CHL Numerator Unit Term (chl_numerator_unit_term__v)
  • CHL Numerator Unit Term Text (chl_numerator_unit_term_text__v)
  • CLL Denominator Unit Term (cll_denominator_unit_term__v)
  • CLL Denominator Unit Term Text (cll_denominator_unit_term_text__v)
  • CLL Numerator Unit Term (cll_numerator_unit_term__v)
  • CLL Numerator Unit Term Text (cll_numerator_unit_term_text__v)
  • Composition Grouping Description (composition_grouping_description__v)
  • Composition Grouping Description Text (composition_grouping_description_text__v)
  • Ingredient Role Term (ingredient_role_term__v)
  • Ingredient Role Term Text (ingredient_role_term_text__v)
  • Origin of the Substance (origin_of_the_substance__v)
  • Origin of the Substance Code (origin_of_the_substance_code__v)
  • Origin of the Substance Code Text (origin_of_the_substance_code_text__v)
  • Origin of the Substance Term (origin_of_the_substance_term__v)
  • Origin of the Substance Term Text (origin_of_the_substance_term_text__v)
  • PHL Denominator Unit Term (phl_denominator_unit_term__v)
  • PHL Denominator Unit Term Text (phl_denominator_unit_term_text__v)
  • PHL Numerator Unit Term (phl_numerator_unit_term__v)
  • PHL Numerator Unit Term Text (phl_numerator_unit_term_text__v)
  • PLL Denominator Unit Term (pll_denominator_unit_term__v)
  • PLL Denominator Unit Term Text (pll_denominator_unit_term_text__v)
  • PLL Numerator Unit Term (pll_numerator_unit_term__v)
  • PLL Numerator Unit Term Text (pll_numerator_unit_term_text__v)
  • PV Active Substance Term (pv_active_substance_term__v)
  • PV Active Substance Term Text (pv_active_substance_term_text__v)
  • PV Inactive Ingredient Term (pv_inactive_ingredient_term__v)
  • PV Inactive Ingredient Term Text (pv_inactive_ingredient_term_text__v)
• Added the following fields to the IDMP Manufacturing Site (idmp_manufacturing_site__v) object:
  • Confidentiality Indicator Term (confidentiality_indicator_term__v)
  • Confidentiality Indicator Term Text (confidentiality_indicator_term_text__v)
  • Operation Type Term (operation_type_term__v)
  • Operation Type Term Text (operation_type_term_text__v)
• Added the following fields to the IDMP Marketing Authorisation Element (idmp_marketing_authorisation_element__v) object:
  • Authorisation Status Term (authorisation_status_term__v)
  • Authorisation Status Term Text (authorisation_status_term_text__v)
  • Country Term (country_term__v)
  • Country Term Text (country_term_text__v)
  • Marketing Authorisation Regulator (marketing_authorisation_regulator__v)
  • Procedure End Date (procedure_end_date__v)
  • Procedure End Date Text (procedure_end_date_text__v)
  • Procedure Submission Start Date (procedure_submission_start_date__v)
  • Procedure Submission Start Date Text (procedure_submission_start_date_text__v)
  • Procedure Type Term (procedure_type_term__v)
  • Procedure Type Term Text (procedure_type_term_text__v)
  • Reg Application Procedure Type Term (reg_application_procedure_type_term__v)
  • Reg Application Procedure Type Term Text (reg_application_procedure_type_term_text__v)
  • Regulatory Application End Date (regulatory_application_end_date__v)
  • Regulatory Application End Date Text (regulatory_application_end_date_text__v)
  • Regulatory Authorisation Type Term (regulatory_authorisation_type_term__v)
  • Regulatory Authorisation Type Term Text (regulatory_authorisation_type_term_text__v)
• Added the following fields to the IDMP Master File (idmp_master_file__v) object:
  • Master File Type Term (master_file_type_term__v)
  • Master File Type Term Text (master_file_type_term_text__v)
• Added the following fields to the IDMP Medicinal Product Element (idmp_medicinal_product_element__v) object:
  • Authorised Pharmaceutical Form (authorised_pharmaceutical_form__v)
  • Authorised Pharmaceutical Form Code (authorised_pharmaceutical_form_code__v)
  • Authorised Pharmaceutical Form Code Text (authorised_pharmaceutical_form_code_text__v)
  • Authorised Pharmaceutical Form Term (authorised_pharmaceutical_form_term__v)
  • Authorised Pharmaceutical Form Term Text (authorised_pharmaceutical_form_term_text__v)
  • Combined Pharma Dosage Form Term (combined_pharma_dosage_form_term__v)
  • Combined Pharma Dosage Form Term Text (combined_pharma_dosage_form_term_text__v)
  • Domain Term (domain_term__v)
  • Domain Term Text (domain_term_text__v)
  • Legal Status of Supply Term (legal_status_of_supply_term__v)
  • Legal Status of Supply Term Text (legal_status_of_supply_term_text__v)
  • Medicinal Product Type Term (medicinal_product_type_term__v)
  • Medicinal Product Type Term Text (medicinal_product_type_term_text__v)
  • PMS ID (pms_id__v)
  • PMS ID Text (pms_id_text__v)
  • Role Term (role_term__v)
  • Role Term Text (role_term_text__v)
• Added the following fields to the IDMP Medicinal Product Full Name (idmp_medicinal_product_full_name__v) object:
  • Country Term (country_term__v)
  • Country Term Text (country_term_text__v)
  • Language Term (language_term__v)
  • Language Term Text (language_term_text__v)
• Added the following fields to the IDMP Medicinal Product Indication (idmp_medicinal_product_indication__v) object:
  • Language Term (language_term__v)
  • Language Term Text (language_term_text__v)
• Added the following fields to the IDMP Name Part (idmp_name_part__v) object:
  • Name Part Type Term (name_part_type_term__v)
  • Name Part Type Term Text (name_part_type_term_text__v)
• Added the following fields to the IDMP Package Authorisation Status (idmp_package_authorisation_status__v)  object:
  • Authorisation Status Term (authorisation_status_term__v)
  • Authorisation Status Term Text (authorisation_status_term_text__v)
  • Country Term (country_term__v)
  • Country Term Text (country_term_text__v)
  • Regulatory Authorisation Type Term (regulatory_authorisation_type_term__v)
  • Regulatory Authorisation Type Term Text (regulatory_authorisation_type_term_text__v)
• Added the following fields to the IDMP Package Description (idmp_package_description__v) object:
  • Language Term (language_term__v)
  • Language Term Text (language_term_text__v)
• Added the following fields to the IDMP Package Marketing Status (idmp_package_marketing_status__v) object:
  • Country Term (country_term__v)
  • Country Term Text (country_term_text__v)
  • Marketing Status Term (marketing_status_term__v)
  • Marketing Status Term Text (marketing_status_term_text__v)
  • Restore Date (restore_date__v)
  • Restore Date Text (restore_date_text__v)
  • Risk of Supply Shortage (risk_of_supply_shortage__v)
  • Risk of Supply Shortage Comment (risk_of_supply_shortage_comment__v)
  • Risk of Supply Shortage Comment Text (risk_of_supply_shortage_comment_text__v)
  • Risk of Supply Shortage Text (risk_of_supply_shortage_text__v)
  • Status Reason (status_reason__v)
  • Status Reason Code (status_reason_code__v)
  • Status Reason Code Text (status_reason_code_text__v)
  • Status Reason Term (status_reason_term__v)
  • Status Reason Term Text (status_reason_term_text__v)
• Added the following fields to the IDMP Packaged Medicinal Product Element (idmp_packaged_medicinal_product_element__v) object:
  • Legal Status of Supply Term (legal_status_of_supply_term__v)
  • Legal Status of Supply Term Text (legal_status_of_supply_term_text__v)
• Added the following fields to the IDMP Pharmaceutical Product Element (idmp_pharmaceutical_product_element__v) object:
  • Administrable Dosage Form Term (administrable_dosage_form_term__v)
  • Administrable Dosage Form Term Text (administrable_dosage_form_term_text__v)
  • Medical Device Type Term (medical_device_type_term__v)
  • Medical Device Type Term Text (medical_device_type_term_text__v)
  • Unit of Presentation Term (unit_of_presentation_term__v)
  • Unit of Presentation Term Text (unit_of_presentation_term_text__v)
• Added the following fields to the IDMP Name Part (idmp_name_part__v) object:
  • Reference Product Type Term (reference_product_type_term__v)
  • Reference Product Type Term Text (reference_product_type_term_text__v)
• Added the following fields to the IDMP Product Cross Reference (idmp_product_cross_reference__v) object:
  • Reference Product Type Term (reference_product_type_term__v)
  • Reference Product Type Term Text (reference_product_type_term_text__v)
• Added the following fields to the IDMP Regulatory Authorisation (idmp_regulatory_authorisation__v) object:
  • Orphan Designation Status Term (orphan_designation_status_term__v)
  • Orphan Designation Status Term Text (orphan_designation_status_term_text__v)
  • Regulatory Authorisation Type Term (regulatory_authorisation_type_term__v)
  • Regulatory Authorisation Type Term Text (regulatory_authorisation_type_term_text__v)
• Added the following fields to the IDMP Route of Administration (idmp_route_of_administration__v) object:
  • Route of Administration Term (route_of_administration_term__v)
  • Route of Administration Term Text (route_of_administration_term_text__v)
• Added the following fields to the IDMP Shelf Life (idmp_shelf_life__v) object:
  • Shelf Life Time Period Unit Term (shelf_life_time_period_unit_term__v)
  • Shelf Life Time Period Unit Term Text (shelf_life_time_period_unit_term_text__v)
  • Shelf Life Type Term (shelf_life_type_term__v)
  • Shelf Life Type Term Text (shelf_life_type_term_text__v)
• Added the following fields to the IDMP Storage Precaution (idmp_storage_precautions__v) object:
  • Storage Precautions Term (storage_precaution_term__v)
  • Storage Precautions Term Text (storage_precaution_term_text__v)

Added the following components to support the Publish with Overlays feature:

• Added the Include eSignatures (include_esignatures__v) field to the Content Plan Item (edl_item__v) object.
• Added the Default Overlay (default_overlay__v) field to the Submission (submission__v) and Report Level Content Plan (report_level_content_plan__v) objects.
• Added the Overlay ID (overlay_id__v) field to the Publishing Element (publishing_element__v) object.
• The TocTemplate (toc_template__v) and Page Numbering (page_number__v) fields on the Publishing Element (publishing_element__v) object are no longer required.
• Added an app control field (publishing_element_overlay__c) to the Publishing Element (publishing_element__v) object (enabled via Page Layouts).

Added the following components to support Manage Registered Details Enhancements:

• Objects:
  • Registered Authorization (registered_authorization__v)
  • Registered Regulatory Text (registered_regulatory_text__v)
• Impacted Record (impacted_record__v) picklist values: 
  • Registered Authorization (registered_authorization__v)
  • Registered Regulatory Text (registered_regulatory_text__v)

To support the EUDAMED UDI XML Generation for Regulation & Legacy Devices feature:

• Added the Submission Authorization (submission_authorization__v) object
• Added the Device Premarket Submission (device_premarket_submission__v) object type to the Registered Authorization (registered_authorization__v) object
• Added the following fields to the Classification (classification__v) object:
  • Parent (parent__v)
  • Category (category__v)
  • Lowest Level (lowest_level__v)
• Within the Organization (organization__rim) object:
  • Added the EUDAMED Sender ID (eudamed_sender_id__v) field
  • Increased the GUDID Code (gudid_code__v) field length to 128
  • Added the Use for UDI (use_for_udi__v) field to the following objects:
    • Submission Shelf Life or Condition (submission_shelf_life_storage__v)
    • Regulatory Objective ShelfLife Condition (regulatory_objective_shelf_life_storage__v)
• Added the Applicable Device Legislation (applicable_device_legislation__v) value to the Controlled Vocabulary Type (controlled_vocabulary_type__rim) picklist
• Updated the Characteristic Value (characteristic_value__v) field to be optional within the Regulatory Objective Packaging Characteristic (reg_objective_packaging_characteristic__v) object