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# ICH M12 Drug Interaction Guideline Out
- URL: https://www.fdaweb.com/ich-m12-drug-interaction-guideline-out/
- Published: 2024-05-29T12:00:00.000Z
- Updated: 2026-09-14T14:31:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157077

The International Council for Harmonization (ICH) has published the M12 final guideline on drug interaction studies. The [document](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDIsInVyaSI6ImJwMjpjbGljayIsInVybCI6Imh0dHBzOi8vZGF0YWJhc2UuaWNoLm9yZy9zaXRlcy9kZWZhdWx0L2ZpbGVzL0lDSF9NMTJfU3RlcDRfUSUyNkFzXzIwMjNfMDUyMS5wZGY%5FdXRtX21lZGl1bT1lbWFpbCZ1dG1fc291cmNlPWdvdmRlbGl2ZXJ5IiwiYnVsbGV0aW5faWQiOiIyMDI0MDUyOS45NTQ4MTg5MSJ9.EtcCi2qOezUKQ6yc1xnLkDqvH%5F7qyza9FaA-%5FBF2xNU/s/1255931999/br/243260581268-l?ref=fdaweb.com) has recommendations to promote a consistent approach in designing, conducting, and interpreting enzyme- or transporter-mediated *in vitro* and clinical drug-drug interaction studies during the development of a therapeutic product.

The guideline says a consistent approach will reduce uncertainty for the pharmaceutical industry to meet the requirements of multiple regulatory agencies and lead to more efficient utilization of resources. It says the approach will lead to effective and safe treatment for patients who take multiple medications.

The guideline scope is limited to pharmacokinetic interactions, with a focus on metabolic enzyme- and transporter-mediated interactions. These aspects generally apply to the development of small chemical molecules, it says.

ICH says that in response to questions posted during the M12 comment period, a question-and-answer [document](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDEsInVyaSI6ImJwMjpjbGljayIsInVybCI6Imh0dHBzOi8vZGF0YWJhc2UuaWNoLm9yZy9zaXRlcy9kZWZhdWx0L2ZpbGVzL0lDSF9NMTJfU3RlcDRfR3VpZGVsaW5lXzIwMjRfMDUyMV8wLnBkZj91dG1fbWVkaXVtPWVtYWlsJnV0bV9zb3VyY2U9Z292ZGVsaXZlcnkiLCJidWxsZXRpbl9pZCI6IjIwMjQwNTI5Ljk1NDgxODkxIn0.ZZK03iCoFU7aOH2LPdWqwnggDmsBD5Q%5FhM9ZpHnhH5A/s/1255931999/br/243260581268-l?ref=fdaweb.com) was developed to provide clarity around some of the concepts related to evaluation of drug interaction covered in the M12 guideline.