# M5International Conference on Harmonisation; Draft Guidance on M5 Data Elements and Standards for Drug Dictionaries - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/m5international-conference-on-harmonisation-draft-guidance-on-m5-data-elements-and-standards-for-drug-dictionaries/d4c223eb-7ce8-43b0-9cf7-93a7d505c695

> FDA guidance document: M5International Conference on Harmonisation; Draft Guidance on M5 Data Elements and Standards for Drug Dictionaries. Issue date: September 06, 2005. Get complete insights and analysis.

---

## Details

- Title: M5International Conference on Harmonisation; Draft Guidance on M5 Data Elements and Standards for Drug Dictionaries
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2005-09-06
- Last Changed: 2020-04-24
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2005-D-0459">FDA-2005-D-0459</a>

## Related Documents

- [Compliance Policy Guide Sec 390200 Determination by Secretary that Product Fails to Comply or has Defect - 21 CFR 100311](https://www.globalkeysolutions.net/guidances/compliance-policy-guide-cpg/compliance-policy-guide-sec-390200-determination-by-secretary-that-product-fails-to-comply-or-has-defect-21-cfr-100311/6f05a7c9-686e-476e-9f55-da69eef06462)
- [E2D Postapproval Safety Data Management: Definitions and Standards for Expedited Reporting](https://www.globalkeysolutions.net/guidances/guidance-document/e2d-postapproval-safety-data-management-definitions-and-standards-for-expedited-reporting/34c1364c-ea36-4314-8bc7-bb62b5e1de2f)
- [PDEs for Triethylamine and for Methylisobutylketone](https://www.globalkeysolutions.net/guidances/guidance-document/pdes-for-triethylamine-and-for-methylisobutylketone/c3d4c7db-7f2f-4f5c-a410-e930c81766c9)