Download our Drug Approval Ontology

Lettria’s Drug Approval ontology maps the intricate requirements for US and European drug applications in line with the official texts that govern them.

‍Use case: Organize information relating to new drug applications, with precise references to the documents where this information can be found.

‍Documents:
- Application for FDA approval to market a new drug
- ICH Topic M 4 Q Common Technical Document for the Registration of Pharmaceuticals for Human Use - Quality
- ICH Topic M 4 Q Location issues for Common Technical Document for the Registration of Pharmaceuticals for Human Use – Quality Questions and Answers

Ontology generated with Lettria’s Ontology Toolkit.
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Class count: 145
Object property count: 41
Data property count: 21