ICH guideline
ICH M8 EWG/IWG: Electronic Common Technical Document (eCTD)
ICH guideline · Multidisciplinary Guidelines · Step 5
Key facts
| ICH code | M8 EWG/IWG |
|---|---|
| Title | Electronic Common Technical Document (eCTD) |
| Guideline series | Multidisciplinary Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | ICH M8 EWG was formed in November 2010 to take over the development and revision of eCTD v4.0 Implementation Guide and related documents from the ICH M2 eCTD Subgroup. The eCTD v4.0 requirements were addressed by the Standard Development Organisation process and are included in the Health Level Seven Version 3… |
| File | M8 Work Plan |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- M8 Work Plan Files published by ICH
- None 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.