ICH guideline
ICH M15 EWG: General Principles for Model-Informed Drug Development
ICH guideline · Multidisciplinary Guidelines · Step 5
Key facts
| ICH code | M15 EWG |
|---|---|
| Title | General Principles for Model-Informed Drug Development |
| Guideline series | Multidisciplinary Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | This topic was endorsed by the ICH Assembly in May 2020. Further to the ICH Management Committee's endorsement of the M15 Concept Paper and Business Plan in November 2022, the M15 EWG was established to develop the ICH M15 Guideline to harmonise Model-Informed Drug Development General Principles (MIDD). The overarching… |
| File | ICH Step 4 Presentation |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- ICH Step 4 Presentation 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.