Regulatory document
ICH Q5E Biotechnological/biological products subject to changes in their manufacturing…
EMA · Guidance · EU · Jun 1, 2005
Key facts
| Title | ICH Q5E Biotechnological/biological products subject to changes in their manufacturing process: comparability of biotechnological/biological products - Scientific guideline |
|---|---|
| Issuer | European Medicines Agency |
| Source | EMA |
| Document type | Guidance |
| Country or region | EU |
| Date | Jun 1, 2005 |
| Document | ema.europa.eu |
| Issuer website | ema.europa.eu |
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