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edmcouncil / idmp

This repository stores the OWL ontology built on the basis of the ISO standards for identification of medicinal products.
https://spec.edmcouncil.org/idmp/
MIT License
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Need to support jurisdiction-specific controlled vocabularies #227

Closed ElisaKendall closed 1 year ago

ElisaKendall commented 1 year ago

Values for some things may be different depending on the jurisdiction.

The pattern for jurisdictions should be revised to be similar to the FIBO pattern, which is more complicated than what we currently have, with a many to many relationship between regulatory agencies and jurisdictions.

For example, for marketing authorization in the EU - EMA is the regulatory agency that recommends isssuance of a marketing authority – EU, Liechtenstein, Norway and Iceland EC is the authorizing party that issues the marketing authority – EU

Note that there are multiple definitions for jurisdiction used - jurisdiction in terms of regulatory authority for enabling marketing of new drugs, jurisdiction in terms of oversight, and we may need to distinguish them.

ElisaKendall commented 1 year ago

Note that there are two Jira issues that correspond to this GitHub issue: IDMP-305 and IDMP-300. The notes above are from IDMP-300, which is a bit more complete than what is in IDMP-305.

ElisaKendall commented 1 year ago

This issue should be closed with respect to IDMP-305, which was merged via pull request #240. An extension to support additional concepts in IDMP-300 will be added under a separate issue.