Any attached file that contains a graphical representation

Any attached file that contains analytical instrument data

An attached PDF file

A profile that represents the document or diagram in base64.

A Document Reference to any attachment tha contains a graphical representation

abstract profile to ensure the reference portion of a codeable reference is used, and that the reference is a literal reference to some resource in a bundle

abstract profile to ensure the reference is always a literal reference. Used in conjuction with a rule set to ensure every reference is also bundled

Any attached file in a submission is required to have a type, data, and a title

Any attached file that contains structure data (e.g. SDFiles, MolFiles, INCHI)

A Document Reference to any attachment that contains structure data

abstract profile for the common scenario where only the text field is used and is required. Doesn't stop the coding portion from being used but it will not be parsed

A profile for the data elements required to identify the sponsor of the drug products or substances, Suppliers.

The Drug Product produced by the batch formula.

Definition for a document bundle with the CMC eCTD 32P1 profiles.

Definition for a document bundle with the CMC eCTD 32P32 profiles (Product Batch Formula).

Definition for a document bundle with the CMC eCTD 32P55 profile (Product Characterisation of Impurities).

Definition for a document bundle with the CMC eCTD 32S1 profiles.

Definition for a document bundle with the CMC eCTD 32S23 profiles.

Definition for a document bundle with the CMC eCTD 32S3 profiles.

Definition for a document bundle with the CMC eCTD SP4151 profiles.

Any raw material intended for use in the manufacture of a drug substance, or any ingredient intended for use in the manufacture of a drug product including those that may not appear in such drug product.

Container Closure for drug product referred to in Drug Product Description.

Listing of all components of the dosage form to be used in the manufacture, their amounts on a per batch basis, including overages, and reference to their quality standards.

The amount details about the drug product ingredients in the batch. Use for Batch Formula.

The amount details about the drug product components to define the product composition in a product unit. Use composition.

Includes the properties of the drug product and components. Profile of Drug Product profile.

Includes the essential identifying information of the drug product required to link to other profiles about the product in the eCTD structure.

List of drug product impurities. Profile of Drug Product profile.

Drug Substance (Active Ingredient) nomenclature and characterisation.

Provides sufficient information to identify a drug substance. Profile on SubstanceDefinition.

Any component of the drug substance that is not the chemical entity for procduct composition.

Provides sufficient information to identify an inactive substance and raw materials and its source when stability data is required in the submission.

The manufactured drug product defined by all its parts or layers. If the drug product composition is homogeneous it will have a single part or component.

Alternate structure present in the drug substance

A quality specification is for a drug product or drug substance (excipient, API or raw material).

Substance General Information containing Drug Substance (Active Ingredient) nomenclature (3.2.S.1.1) and Substance Structure (3.2.S.1.2) profile.

The fields needed to represent the Product Batch Formula to be included under the eCTD. References Sponsor Organization and Batch Formula

The fields needed to represent the Product Characterisation of Impurities in a to be included under the eCTD. References Sponsor Organization and Product Characterisation of Impurities

The fields needed to represent the Product Description, Container Closure and Composition of the Drug Product to be included under the 3.2.P.1 heading of the eCTD. References Sponsor Organization, Drug Product Description, and Product Container Closure System.

The fields needed to represent Quality Specifications for APIs, Drug Substances, Excipients and Raw Materials.

The fields needed to represent the Substance Structure and Impurities to be included under the 3.2.S.3 heading of the eCTD. References Sponsor Organization, Drug Substance Structure, and Drug Substance Impurities

The fields needed to represent the Substance Control of Materials to be included under the eCTD 3.2.S.2.3 heading. References Sponsor Organization and Drug Substance Materials.

The fields needed to represent the Substance Nomenclature and Structure to be included under the 3.2.S.1 heading of the eCTD. References Sponsor Organization.

pq-specific Constraints on the Address datatype dealing with US addresses.

Any additional information that that the submitter wishes to provide to the FDA that is not structured in the IG. The content of the information submitted via Additional Information may be analyzed at some point in the future, to identify candidate elements for structuring in future iterations of the IG.

represent an amount as a ratio in ManufacturedItemDefinition

Extension for measurement properties for ingredients in the batch formla.

Extension for strenght as a string for ingredients in the batch formla.

A classification of the regulatory status of the specification.

Strength Type (for API)

The FHIR Range datatype uses Simple Quantities to represent the high and low bounds, which do not allow a comparator to be set. This extension allows the high and low bounds to have a comparator

The acceptable file types that can be used in Analytical Instrument Data Files

Terminology used to qualify the information pertaining to batch utilization in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

A category of terminology used to qualify the information pertaining to the classification of a capsule in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

Terminology used to qualify the information pertaining to chemical structure data file types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

Terminology used to qualify the information pertaining to closure types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

A category of terminology used to qualify the information pertaining to the coating purpose in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

Terminology used to qualify the information pertaining to container types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

Terminology used to qualify the information pertaining to drug product component function categories in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

Terminology used for representation of the information on pharmaceutical product route of administration in the framework of the Structured Product Labeling documents.

Terminology used to qualify the information pertaining to excipient functions in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

The 3 letter country codes used in GENC and ISO have significant overlap: only the country codes in ISO 3166 that have an equivalent code in GENC may be used

The acceptable file types that can be used in graphical files

Terminology used to qualify the information pertaining to impurity classifications in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

A category of terminology used to qualify the information pertaining to the location of an ingredient within a product in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

Terminology used to qualify the information pertaining to the manufactured dose form.

Units of Measure terminologies that do not represent percentages

Terminology used to qualify the information pertaining to the sponsor or testing site unique identifier types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

Terminology used to qualify the information pertaining to Name Part data in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

Units of Measure terminologies that represent the concept of a percentage

Terminology used for representation of the information on pharmaceutical product dosage form in the framework of the SPL documents.

The type of the product name. Often the proprietary name is unknow at the time of submission.

A category of terminology used to qualify the information pertaining to the product part type in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

Terminology used to qualify the information pertaining to quality benchmarks in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

A category of terminology used to qualify the information pertaining to release mechanism in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

A category of terminology used to qualify the information pertaining to release profile in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

The different types of representations (graphical, structure/file and structure/text)

Terminology used to qualify the information pertaining to source types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

Local value set of all codes in Specification Type codes

Terminology used to qualify the information pertaining to specification statuses in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

Terminology used to qualify the information pertaining to specification types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

Terminology used to qualify the information pertaining to strength types in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

The acceptable file types that can be used in Structure Data Files (MOL,SDF,INCHI,etc)

Substance classes

A category of terminology used to quality the information pertaining to the type of substance name in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

Terminology used to qualify the information pertaining to test categories in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

Terminology used to qualify the information pertaining to test method origins in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

Terminology used to qualify the information pertaining to test usage in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents.

Terminology used to qualify the information pertaining to units of measure in the framework of the Pharmaceutical Quality/Chemistry, Manufacturing and Controls documents. Note: Includes SPL Unit of Presentation Terminology

Value set of all codes in Code system PQCMC Comp Section Types.

Provides hierarchical relationships for value sets as a CodeSystem supplement to the NCI Thesaurus (NCIt)

Example of a document bunlde for 3.2.S.3

FHIR document bundle with the CMC eCTD SP4151 profile for an Excipient

FHIR document bundle with the CMC eCTD 32P55 profile for a Drug Product

Bundle containng nomenclature and molecular structure

A bundle for 3.2.P.1.0

FHIR bundle with a CMC eCTD 32P32 profile

FHIR bundle with a CMC eCTD 32P32 profile - with layers

FHIR document bundle with the CMC eCTD SP4151 profile for a Drug Product

FHIR document bundle with the CMC eCTD SP4151 profile for a Drug Substance

An SDF file in a Structure Reference

This is an example of the Substance Control of Materials bundle profile. It is to submit Module 3 of CTD 3.2.S.2.3 folder content to the FDA.