ICH guideline
ICH E16: Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure and…
ICH guideline · Efficacy Guidelines · Step 5
Key facts
| ICH code | E16 |
|---|---|
| Title | Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure and Format of Qualification Submissions |
| Guideline series | Efficacy Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The ICH Harmonised Guideline was finalised under Step 4 in August 2010. The Guideline describes recommendations regarding context, structure, and format of regulatory submissions for qualification of genomic biomarkers, as defined in ICH E15. |
| File | E16 Step 4 Audio Presentation (zip) |
| File type | Zip |
| File on ich.org | database.ich.org |
At a glance
- No Full text searchable in Orca1
- E16 Step 4 Audio Presentation (zip) Files published by ICH
- 1–9 FDA guidance documents based on this guideline
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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.