# publisher
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

# description
Codes are found within the vocabulary package at the link above which is available from this page: [https://ich.org/page/ich-electronic-common-technical-document-ectd-v40](https://ich.org/page/ich-electronic-common-technical-document-ectd-v40). Specifically, the codes are in the “ICH Context of Use” tab of the "ICH M8 OID Listing_eCTDv4_v5.xlsx" workbook. The codes are part of the ICH implementation of HL7 V3 Standard: Regulated Studies; Regulated Product Submissions (RPS), Release 2 Normative (described here: [https://www.hl7.org/implement/standards/product_brief.cfm?product_id=38](https://www.hl7.org/implement/standards/product_brief.cfm?product_id=38))

When using this uri in FHIR, the version identifier is mandatory and the code system uri cannot be used without it.

This system uses an integer based versioning system in conjunction with an OID update. For example, if the version of the system is v5, the OID is 2.16.840.1.113883.3.989.2.2.1.1.5. This system has an OID stem of 2.16.840.1.113883.3.989.2.2.1.1.

# copyright
"The information, material and photographic content provided on this website are protected by copyright and may, with the exception of the ICH logo, be used, reproduced, incorporated into other works, adapted, modified, translated or distributed under a public license provided that ICH's copyright in the information and material is acknowledged at all times. In case of any adaption, modification or translation of the information, material or photographic content, reasonable steps must be taken to clearly label, demarcate or otherwise identify that changes were made to or based on the original information or material. Any impression that the adaption, modification or translation of the original information or material is endorsed or sponsored by the ICH must be avoided."

For more information, see [https://ich.org/page/legal-mentions](https://ich.org/page/legal-mentions)

# concept[].display
m3.2.p.4.5 excipients of human or animal origin

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m3.2.p.4.3 validation of analytical procedures

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m3.2.a.2 adventitious agents safety evaluation

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m3.2.p.8.2 post-approval stability protocol and stability commitment

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m3.2.s.2.4 controls of critical steps and intermediates

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m3.2.p.2.1 components of the drug product

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m2.3.a.2 adventitious agents safety evaluation

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m5.3.2.3 reports of studies using other human biomaterials

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m5.3.3.4 extrinsic factor pk study reports

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m5.3.5.3 reports of analyses of data from more than one study

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m5.3.6 reports of postmarketing experience

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m3.2.s.7.1 stability summary and conclusions

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m4.2.1 4 pharmacodynamic drug interactions

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m5.3.1 4 reports of bioanalytical and analytical methods for human studies

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m3.2.p.3.5 process validation and/or  evaluation

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m5.3.3 3 intrinsic factor pk study reports

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m5.3.5.2 study reports of uncontrolled clinical studies

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m5.3.4.1 healthy subject pd and pk/pd study reports

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m3.2.s.2.5 process validation and/or  evaluation

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m5.3.2.1 plasma protein binding study reports

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m3.2.s.2.2 description of manufacturing process and process controls

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m3.2.s.5 reference standards or materials

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m3.2.s.3.1 elucidation of structure and other characteristics

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m5.3.2.2 reports of hepatic metabolism and drug interaction studies

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m5.3.1 2 comparative ba and bioequivalence study reports

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m5.3.5.1 study reports of controlled clinical studies pertinent to the claimed indication

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m3.2.p.5.3 validation of analytical procedures

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m5.2 tabular listing of all clinical studies

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m2.7.1 summary of biopharmaceutic studies and associated analytical methods

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m4.2.3.5.1 fertility and early embryonic development

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m3.2.p.1 description and composition of the drug product

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m4.2.3.5.4 studies in which the offspring juvenile animals are dosed and/or further evaluated

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m3.2.p.3.3 description of manufacturing process and process controls

# concept[].display
m5.3.4.2 patient pd and pk/pd study reports

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m2.7.2 summary of clinical pharmacology studies

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m3.2.p.6 reference standards or materials

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m3.2.p.3.4 controls of critical steps and intermediates

# concept[].display
m5.3.1 3 in vitro  in vivo correlation study reports

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m4.2.3.5.3 prenatal and postnatal development, including maternal function

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m5.3.7 case report forms and individual patient listings

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m5.3.3.2 patient pk and initial tolerability study reports

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m3.2.s.4.3 validation of analytical procedures

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m4.2.2.1 analytical methods and validation reports

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m5.3.3.1 healthy subject pk and initial tolerability study reports

# concept[].display
m3.2.s.7.2 post-approval stability protocol and stability commitment

# concept[].display
m3.2.p.8.1 stability summary and conclusion