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# ICH Pharmacoepidemiological Study Guidance Out
- URL: https://www.fdaweb.com/ich-pharmacoepidemiological-study-guidance-out/
- Published: 2024-05-28T12:00:00.000Z
- Updated: 2026-09-14T14:31:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157067

FDA has published for public comment the International Council for Harmonization M14 guidance, *General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies that Utilize Real-World Data for Safety Assessment of Medicines*. The [document](https://database.ich.org/sites/default/files/ICH%5FM14%5FStep3%5FDraftGuideline%5F2024%5F0521.pdf?ref=fdaweb.com) recommends international standards for, and promotes harmonization of, the general principles on planning, designing, and analyzing observational (non-interventional) pharmacoepidemiological studies that use fit-for-purpose data for safety assessment of medicines.

The guidance says it includes recommendations for studies using real-world data conducted to evaluate the post-marketing safety of medicinal products. “It is beyond the scope of this document to provide guidance on whether a clinical trial or a pharmacoepidemiological study is the most appropriate approach,” it says, “nor is it intended as a comprehensive source of knowledge for pharmacoepidemiological methods.”