Reference:ICH ICH E6 Guideline R3 (2025) GLOSSARY - Regulatory Authorities
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| Document information | |
|---|---|
| Reference | ICH ICH E6 Guideline R3 (2025) |
| Validity area | ICH |
| Scope(s) | HM |
| Document name | ICH E6 Guideline |
| Version / Revision | R3 (2025) |
| Status | Current |
| Document type | International guideline |
| Language(s) | EN |
| Description | GUIDELINE FOR GOOD CLINICAL PRACTICE |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 1 — Unit 1.5.2 |
| Scope | G |
| Document part | GLOSSARY - Regulatory Authorities |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Competent authority, Definition, Inspection |
Content
Regulatory Authorities Bodies having the power to regulate, including those that review submitted protocols and clinical data and those that conduct inspections. These bodies are sometimes referred to as competent authorities.
