ICH guideline
ICH M1: MedDRA - Medical Dictionary for Regulatory Activities
ICH guideline · Multidisciplinary Guidelines · Step 5
Key facts
| ICH code | M1 |
|---|---|
| Title | MedDRA - Medical Dictionary for Regulatory Activities |
| Guideline series | Multidisciplinary Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The development of a Medical Dictionary for Regulatory Activities (MedDRA) was approved by the ICH Steering Committee in 1997, and the terminology was launched in 1999. Due to the development of this topic over the years, all information about MedDRA and the Points to Consider documents developed for every MedDRA… |
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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.