ICH guideline
ICH M1 PtC WG: MedDRA Points to Consider
ICH guideline · Multidisciplinary Guidelines
Key facts
| ICH code | M1 PtC WG |
|---|---|
| Title | MedDRA Points to Consider |
| Guideline series | Multidisciplinary Guidelines |
| ICH summary (excerpt) | The MedDRA (Medical Dictionary for Regulatory Activities) terminology was launched in 1999.To support the use of MedDRA, the M1 PtC WG updates with each MedDRA release the two Points to Consider (PtC) documents on MedDRA Term Selection and MedDRA Data Retrieval and Presentation, available in English and Japanese, as… |
| File | M1 PtC Working Group |
| File type | |
| File on ich.org | database.ich.org |
At a glance
- Yes Full text searchable in Orca1
- M1 PtC Working Group 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.