The International Council for Harmonisation (ICH) has adopted its M12 guidance, which promotes a harmonized approach in conducting and interpreting enzyme- or transporter-mediated in vitro and clinical drug-drug interaction (DDI) studies during the development of an investigational therapeutic drug. Step 4 means the document is ready for regulators to adopt in their jurisdictions.
ICH also announced the availability of the ICH M14 guidance on use of real-world data (RWD) to support drug development on 24 May.
The ICH M12 DDI guidance was released for public consultation in May 2022. (RELATED: EMA consults on ICH M12 guideline for drug-drug interaction studies, Regulatory Focus 25 July 2022)
The M12 guidance generated over 1,000 comments from 20 pharmaceutical companies; the industry said it wanted more clarity on the timing of DDI studies as well as the scope of these studies. (RELATED: ICH to adopt final guideline on drug interaction studies early next year, Regulatory Focus 27 February 2023)…
