ICH guideline
ICH Q8(R2): Pharmaceutical Development
ICH guideline · Quality Guidelines · Step 5
Key facts
| ICH code | Q8(R2) |
|---|---|
| Title | Pharmaceutical Development |
| Guideline series | Quality Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The core ICH Harmonised Guideline was finalised under Step 4 in November 2005. This Guideline is intended to provide guidance on the contents of Section 3.2.P.2 (Pharmaceutical Development) for drug products as defined in the scope of Module 3 of the Common Technical Document (ICH topic M4). The guideline does not… |
| File | ICH Q8(R2) Guideline |
| File type | |
| File on ich.org | database.ich.org |
At a glance
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- ICH Q8(R2) Guideline Files published by ICH
- 1–9 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.