Details
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Comment
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Resolution: Considered - No action required
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High
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FHIR Core (FHIR)
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R5
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Biomedical Research & Regulation
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Home (index)
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Description
The PQ/CMC project is in the US domain and does not conform to the US Core. The US core is for a specific patient focused use case, while the PQ/CMC use case is for the development and manufacture of pharmaceutical products. As an example, US Core requires a zip code which is very specific and very impractical. 99% of the ingredient for US manufactured drugs come from China and India. They do not have zip codes. The Index.html comparison report is attached for a review of the other variances. Details from the links can be provided. We are requesting an exemption from compliance with US Core.
Attachments
Issue Links
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FHIR-44844 Exemption from comparison to US Common Core -Document Reference Attachment
- Resolved - No Change
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FHIR-44845 Exemption from comparison to US Common Core - Sponsor Organization
- Resolved - No Change
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FHIR-44846 Exemption from comparison to US Common Core - Manufacturing and/or Test Site Organization
- Resolved - No Change
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FHIR-44848 Exemption from comparison to US Common Core - Multiple Result Observation
- Resolved - No Change
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FHIR-44849 Exemption from comparison to US Common Core - Result Observation
- Resolved - No Change
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FHIR-44850 Exemption from comparison to US Common Core - Batch Analysis
- Resolved - No Change
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FHIR-44851 Exemption from comparison to US Common Core - Drug Product Manufactured Instance
- Resolved - No Change
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FHIR-44852 Exemption from comparison to US Common Core - Stability Study Interval Report
- Resolved - No Change
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FHIR-44853 Exemption from comparison to US Common Core - Supplier Organization
- Resolved - No Change
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FHIR-44854 Non-clinical realm code
- Resolved - No Change