[25] The United States Food and Drug Administration requires in its Manual of Policies and Procedures (MaPP) 7400.13 dated July 18, 2013 and updated on July 25, 2018, that MED-RT be used for selecting an established pharmacologic class (EPC) for the Highlights of Prescribing Information in drug labeling.
MOA, PE, and CS standardized indexing concepts may or may not be related to the therapeutic effect of the active moiety for a particular indication, but they should still be scientifically valid and clinically meaningful.
Even if the MOA, PE, and CS standardized indexing concepts are not known with certainty to be related to the therapeutic effect, they may still be useful for identifying drug interactions and permitting other safety assessments for a moiety based upon appropriate and relevant considerations, such as enzyme inhibition and enzyme induction.
MOA, PE, and CS concepts are maintained in a standardized format as part of the MED-RT hierarchy.
https://www.fda.gov/media/86437/download The United States Food and Drug Administration Study Data Technical Conformance Guide dated July 2020 states, "6.5 Pharmacologic Class 6.5.1 Medication Reference Terminology 6.5.1.1 General Considerations The Veterans Administration's Medication Reference Terminology (MED-RT) should be used to identify the pharmacologic class(es) of all active investigational substances that are used in a study (either clinical or nonclinical).
Pharmacologic class is a complex concept that is made up of one or more component concepts: mechanism of action (MOA), physiologic effect (PE), and chemical structure (CS).51 The established pharmacologic class is generally the MOA, PE, or CS term that is considered the most scientifically valid and clinically meaningful.
https://www.fda.gov/media/136460/download The United States Food and Drug Administration publishes a Data Standards Catalog that lists the data standards and terminologies that FDA supports for use in regulatory submissions to better enable the evaluation of safety, effectiveness, and quality of FDA-regulated products.
Where the Catalog expresses support for more than one standard or terminology for a specific use, the sponsor or applicant may select one to use or can discuss, as appropriate, with their review division.
[29] SNOMED CT contains more than 311,000 active concepts with unique meanings and formal logic-based definitions organised into hierarchies.
[28] SNOMED CT can be used by anyone with an Affiliate License, 40 low income countries defined by the World Bank or qualifying research, humanitarian and charitable projects.
Maintained by the World Health Organization (WHO),[30] its primary purpose is to categorise diseases for morbidity and mortality reporting.
ICD has a hierarchical structure, and coding in this context, is the term applied when representations are assigned to the words they represent.
The current version of the ICD, ICD-10, was endorsed by WHO in 1990. WHO Member states began using the ICD-10 classification system from 1994 for both morbidity and mortality reporting.
The next major version of the ICD, ICD-11, was ratified by the 72nd World Health Assembly on 25 May 2019, and member countries have been able to report data using ICD-11 codes since 1 January 2022.
It includes extension codes, a terminology system, with medicaments, chemicals, infections agents, histopathology, anatomy and mechanisms, objects and animals, and other elements that serve to describe sources of injury or harm.
[31] As a core terminology for the EHR, SNOMED CT and ICD-11 provide a common language that enables a consistent way of capturing, and sharing health data across specialities and sites of care.
In contrast to SNOMED, ICD-11 allows full clinical documentation while permitting internationally agreed statistical aggregation for specific use cases.
The foundation of ICD-11 together with the WHO Classification of Health Interventions (ICHI) and the WHO Classification for Functioning, Disability and Health (ICF), comprising also the WHO lists of anatomy, substances and more, are a complete ecosystem for lossless documentation in digital records and at the same time they address specific usecases for data aggregation in a multilingual, freely usable way.
SNOMED CT concepts are defined logically by their attributes, as is the case in ICD-11, that in addition has textual rules and definitions.