Japanese Electronic Medicinal Product Information (ePI-JP), published by Gravitate Health Project. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/cander2/epi-jp/ and changes regularly. See the Directory of published versions

Mapping to ePI

High Level FHIR Resource Mappings to PMDA XML in ePI-JP IG

The following is a high level mapping describing how elements from the PMDA XML schema for Japanese Package Inserts could be translated into the ePI-JP Implementation Guide, based on the core ePI IG. It ensures structured, interoperable representation of product information, with each FHIR resource handling specific aspects of the XML data.

Below is a high-level overview of the mappings, focusing on major PMDA XML elements like Document/ProductName, Indications, DosageForm, Document/Manufacturer, ActiveIngredient/Name, Packaging, ApprovalDate, and PhysicoChemicalProperties:

Only the specified FHIR resources are in scope: Bundle, Composition, MedicinalProductDefinition, Ingredient, ManufacturedItemDefinition, AdministrableProductDefinition, PackagedProductDefinition, RegulatedAuthorization, ClinicalUseDefinition (Indication, Contraindication, Interaction, UndesirableEffect subtypes), MedicationKnowledge, Binary, Organization, and SubstanceDefinition.

The table below details the mapping.

FHIR ePI Resource	PMDA XML Element	Notes
Composition	Date of preparation	In Composition.date or extension for preparation date.
	Date of Revision	In Composition.version or event history.
	Version	In Composition.version.
	Language	In Composition.language.
	Warnings	In Composition.section for warnings/precautions.
	Important precautions	In Composition.section for precautions.
	Category Name for Free Items	In Composition.section.title for free text sections.
	Content for Free Items	In Composition.section.text.
	Title	In Composition.title or section.title.
	Footer	In Composition.section.text or extension.
	Precautions	In section for precautions.
	Clinical use	In clinical studies section.
	Non-clinical trials	In non-clinical data section.
	MainLiterature	In references section.
MedicinalProductDefinition	Japanese Standard Commodity Classification Number (Sccj no)	In MedicinalProductDefinition.classification or identifier.
	Therapeutic Classification Name	In MedicinalProductDefinition.classification.
	StandardName	In MedicinalProductDefinition.name.productName or additionalName.
	Regulatory Classification	In MedicinalProductDefinition.classification.
	GenericName	In MedicinalProductDefinition.name.productName (generic variant).
	Brand name	In MedicinalProductDefinition.name.productName.
	YJ code	In MedicinalProductDefinition.identifier (YJ code system).
	Trademark name (English)	In MedicinalProductDefinition.name.productName with language code.
	Brand name hiragana	In MedicinalProductDefinition.name.productName with language variant.
	Brand name	In MedicinalProductDefinition.name.productName.
	RegulatoryClassificationCode	In MedicinalProductDefinition.classification.code.
	Drug name	In name.
Ingredient	Composition	Overall composition in ManufacturedItemDefinition or Ingredient.
	Active ingredient	In Ingredient.substance.
	Excipients	In Ingredient for non-active components.
ManufacturedItemDefinition	Property	In ManufacturedItemDefinition.property.
	Physical characteristics (size, colour, shape, flavour, imprint, score, image, text description, Size (diameter, long diameter, short diameter, total length, thickness, area)	In ManufacturedItemDefinition.property for characteristics like size, color, shape; Binary for images.
	Appearance Surface, back, side, other	In ManufacturedItemDefinition.property or Binary for images.
	Dose form	In manufacturedDoseForm
	Odour	In property.
	Taste	In property.
AdministrableProductDefinition	Dose form	In AdministrableProductDefinition.formOf or doseForm.
PackagedProductDefinition	Storage, Expiration Period	In PackagedProductDefinition.shelfLifeStorage.
	Shelf life and storage	In PackagedProductDefinition.shelfLifeStorage.
	packaging	Primary packaging details.
RegulatedAuthorization	Approval Number, Starting Date of Marketing	In RegulatedAuthorization.identifier (approval number) and RegulatedAuthorization.validityPeriod (start date).
	ApprovalNo	In RegulatedAuthorization.identifier.
	StartingDateOfMarketing	In RegulatedAuthorization.validityPeriod.start.
ClinicalUseDefinition (Indication subtype)	Indications	Specific for indications.
ClinicalUseDefinition (Contraindication subtype)	Contraindications	Specific resource for contraindications.
ClinicalUseDefinition (UndesirableEffect subtype)	Serious Adverse Events	For adverse reactions and serious events.
	Undesirable effects	For adverse effects.
MedicationKnowledge	Dose and administration	In Composition.section for dosage instructions.
	Dosage precautions	In dosage section precautions.
Organization	Manufacturers and Distributors	Referenced in RegulatedAuthorization.holder or other resources.
	Manufacturer	For manufacturer organization.
	Reference Request and Contact Information	In contact section.
SubstanceDefinition	Physicochemical Knowledge of Active Ingredients	In SubstanceDefinition.property for physicochemical info.
	ChemicalName	In name.
	StructuralFormula	SubstanceDefinition reference to Binary for structure.
	MolecularFormula	In molecularFormula.
	MolecularWeight	In molecularWeight.
	DescriptionOfActiveIngredients	In description.
	MeltingPoint	In property.
	PartitionCoefficient	In property.
	Osmotic Pressure Ratio	In property extension.
	Mechanism of action	In MedicationKnowledge.monograph for MoA.