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# ICH E9 Guideline Published
- URL: https://www.fdaweb.com/ich-e9-guideline-published/
- Published: 2019-07-16T12:00:00.000Z
- Updated: 2026-09-15T01:38:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144545

FDA has published the International Conference on Harmonization E9 guideline, *Optimization of Safety Data Collection*. The [document](https://www.fda.gov/media/128313/download?ref=fdaweb.com) says it is intended to provide internationally harmonized guidance on an optimized approach to safety data collection in some late-stage pre-approval or post-approval studies when the safety profile of a drug is sufficiently characterized.

“Optimization of safety data collection using a selective approach may improve the efficiency of clinical studies while reducing the burden to study participants,” the guideline says. Adoption of an internationally harmonized approach to selective safety data collection may facilitate global participation in clinical studies.”

The document includes an Introduction, General Principles, Methods of Implementation, and Relationship with Other Guidelines/Regulations.