Pharmaceutical Quality (Industry)
1.0.0-ballot - ballot International flag

Pharmaceutical Quality (Industry), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of and changes regularly. See the Directory of published versions


Details about each facility or legal entity involved in the manufacture of the medicinal product. This includes but is not limited to: name, identifier, and location address, for marketing authorization holders, sponsors, regulatory authorities, manufacturers, supplier, test site, packaging site.


OrganizationA company or site that performed a test is a manufacturer


eCTD section synthetic source data samples (PDF):

XML and JSON examples of synthetic CTD data:

HTML presentation example of synthetic CTD data:


See Artifacts Index: Organizations