ICH guideline
ICH M9 Q&As: Q&As on Biopharmaceutics Classification System-based Biowaivers
ICH guideline · Multidisciplinary Guidelines · Step 5
Key facts
| ICH code | M9 Q&As |
|---|---|
| Title | Q&As on Biopharmaceutics Classification System-based Biowaivers |
| Guideline series | Multidisciplinary Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The ICH M9 Q&As provide clarity to support the implementation of the ICH M9 Guideline on Biopharmaceutics Classification System (BCS)-based biowaivers in ICH Regulatory Member countries/regions. |
| File | M9 Q&As |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- M9 Q&As 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.