ICH guideline
ICH M8 eCTD v4.0: Electronic Common Technical Document (eCTD) v4.0
ICH guideline · Multidisciplinary Guidelines · Step 5
Key facts
| ICH code | M8 eCTD v4.0 |
|---|---|
| Title | Electronic Common Technical Document (eCTD) v4.0 |
| Guideline series | Multidisciplinary Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The ICH M8 electronic Common Technical Document (eCTD) v4.0 is maintained by the M8 EWG/IWG. The Implementation Guide and related documents can be found on the ESTRI page. |
At a glance
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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.