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  1. FDA Resources for Data Standards

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 which is maintained by the National Cancer Institute / Enterprise Vocabulary Service. Some of the use cases for the FDA Terminology include: content of structured product labeling (package insert); drug registration and listing; and risk evaluation and mitigation strategies (REMS).

FDA Terminology does not comply with the ISO 11239 standard for use in international IDMP. ISO 11239 and the ISO Technical Specification (TS) 20440:2016 specify mandatory attributes for regional dosage form terminologies that cannot be complied with, for example, that each term must be associated with one or more of the following characteristics:  

  1. state of matter
  2. basic dose form
  3. release characteristics
  4. intended site
  5. transformation
  6. administration method

For use in global IDMP and, specifically, for Pharmaceutical Product IDs (PhPIDs), the dosage form code for a particular medicinal product must be the same across regions.  Currently, FDA is working with the ISO Technical Committee 215 Work Group 6  to revise ISO TS20440 and ISO 11239 to ensure that all regions will be able to implement global IDMP.

 

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