ICH guideline
ICH M5: Data Elements and Standards for Drug Dictionaries
ICH guideline · Multidisciplinary Guidelines
Key facts
| ICH code | M5 |
|---|---|
| Title | Data Elements and Standards for Drug Dictionaries |
| Guideline series | Multidisciplinary Guidelines |
| ICH summary (excerpt) | In November 2003, the ICH Steering Committee endorsed a Concept Paper for Topic M5 and subsequently formed the M5 EWG to develop ICH requirements for the standardisation of medicinal product identifiers and related terminology. In particular, a need was identified to harmonise product information that would facilitate… |
| File | Presentation SDOs |
| File type | PowerPoint |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- Presentation SDOs Files published by ICH
- None FDA guidance documents based on this guideline
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About ICH guidelines
ICH guidelines harmonise the technical requirements for registering medicines in the ICH regions. Each guideline moves through a five-step process, from concept paper to adoption and implementation by regulators.