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Dosage Form and Route of Administration

ISO 11239 Dosage Form (DF) and Route of Administration (RoA) specifies data elements and structure that uniquely, and with certainty, identifies pharmaceutical dosage forms, units of presentation and routes of administration related to medicinal product.

FDA’s regional terminology for dosage form and route of administration is the FDA Terminology for Structured Product Labeling (FDA Terminology) which is maintained by the National Cancer Institute / Enterprise Vocabulary Service.  Examples of use cases for the FDA Terminology includes:  content of structured product labeling (package insert); drug registration and listing; and risk evaluation and mitigation strategies (REMS).

Currently, the FDA Terminology does not comply with the ISO 11239 standard for use in global IDMP and specifically for global PhPID.  ISO 11239 and its ISO Technical Specification 20440:2016 specifies hierarchical and mandatory attributes for regional dosage form terminologies that are not part of the structure of the FDA Terminology. 

There is no central standardized dose form terminology for use in global IDMP.   FDA has worked with the ISO Technical Committee 215 Work Group 6 and the Global IDMP Working Group to develop a process that utilizes EDQM dose form characteristics and codes to describe dose forms for use in global IDMP and to revise the ISO TS 20440 and ISO 11239 documents, as needed.

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