Editing Medical classification (section)

====Medication Reference Terminology (MED-RT)====
Medication Reference Terminology (MED-RT) is a terminology created and maintained by [[Veterans Health Administration]] in the [[United States]].<ref>{{cite web|title=National Drug File – Reference Terminology (NDF-RT™) Documentation|publisher=U.S. Veterans Health Administration|url=https://evs.nci.nih.gov/ftp1/NDF-RT/NDF-RT%20Documentation.pdf}}</ref> In 2018, it replaced NDF-RT that was used during 2005–2017. Med-RT is not included in RxNorm but is included in National Library of Medicine's [[UMLS Metathesaurus]]. Prior 2017, NDF-RT was included in RxNorm. The first release of MED-RT was in the spring of 2018.<ref>{{cite web|url=https://evs.nci.nih.gov/ftp1/NDF-RT/Introduction%20to%20MED-RT.pdf |title=Introduction to MED-RT as the Replacement for NDF-RT |publisher=U.S. Veterans Health Administration}}</ref>

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.  Each EPC text phrase is associated with a term known as an EPC concept.  EPC concepts use a standardized format derived from the U.S. Department of Veterans Affairs, Veterans Health Administration (VHA) Medication Reference Terminology (MED-RT).  Each EPC concept also has a unique standardized alphanumeric identifier code, used as the machine-readable tag for the concept.  These codes enable SPL indexing.  The exact EPC text phrase used in INDICATIONS AND USAGE in Highlights might not be identical to the wording used to describe the EPC concept, because the standardized language used for the EPC concept might not be considered sufficiently clear to the readers of the labeling. Each active moiety also may be assigned MOA, PE, and CS standardized indexing concepts, which are also linked to unique standardized alphanumeric identifier codes.  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://web.archive.org/web/20191203114807/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). This information should be provided in the SDTM TS domain when a full TS is indicated. The information should be provided as one or more records in TS, where TSPARMCD= PCLAS. 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. Sponsors should include in TS (the full TS) the established pharmacologic class of all active moieties of investigational products used in a study. FDA maintains a list of established pharmacologic classes of approved moieties.52 If the established pharmacologic class is not available for an active moiety, then the sponsor should discuss the appropriate MOA, PE, and CS terms with the review division. For unapproved investigational active moieties where the pharmacologic class is unknown, the PCLAS record may not be available." 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.  In addition, the FDA has the statutory and regulatory authority to require certain standards and terminologies and these are identified in the Catalog with the date the requirement begins and, as needed, the date the requirement ends, and information sources. The submission of data using standards or terminologies not listed in the Catalog should be discussed with the Agency in advance. 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.  Version 7.0 of the FDA Data Standards Catalog dated 03-15-2021, specifies that MED-RT was a required terminology by the White House Consolidated Health Informatics Initiative in various Federal Register Notices beginning as early as May 6, 2004, for NDAs, ANDAs, and certain BLAs beginning on December 17, 2016, and for certain IND's beginning on December 17, 2017. [https://web.archive.org/web/20190914015733/https://www.fda.gov/media/85137/download]