ICH to adopt final guideline on drug interaction studies early next year

The pharmaceutical industry would like to get more clarity on the timing of drug-drug interaction (DDI) studies and the scope of these DDI studies in their comments to regulators on the proposed International Council for Harmonization’s (ICH) M12 guideline, said a regulator at an ICH regional meeting sponsored by the US Food and Drug Administration (FDA) and Health Canada on 24 February.
 
Rajanikanth Madabushi, associate director for guidance and scientific policy at FDA’s Office of Pharmacology, and a member of the M12 working group, provided an update on the status of the revision at the meeting.
 
The objective of the guideline, which was released last year for public comment, is to promote a consistent approach in designing and conducting DDI studies during the development of a new therapeutic product, said Madabushi. (RELATED: EMA consults on ICH M12 guideline for drug-drug interaction studies, Regulatory Focus 25 July 2022)
 
Currently, the regional disparities in conducting these studies lead to increased drug development costs and delayed patient access to new drugs.
 
Madabushi said the ICH M12 guideline generated over 1,000 comments from 20 pharmaceutical companies, four consortium groups and associations, and a member of academia. The public comment period closed on 30 November 2022.
 
Many of the comments sought clarification on the scope of the guidelines; the current scope is limited to pharmacokinetic interactions, with a focus on enzyme- and transporter-mediated interactions.
 
There were also questions on the timing of DDI evaluations. The guideline states that the timing of the different non-clinical and clinical studies is dependent on the context and type of product. Stakeholders also wanted clarity on the in vitro and in vivo extrapolation criteria for these studies.
 
A meeting will be held in March in Geneva where these comments will be addressed by various subgroups.
 
There are plans to adopt a Step 4 guideline during the first quarter of 2024.
 
The regional meeting aims to solicit input on ICH guidelines prior to the next ICH biennial Assembly meeting in June 2023 in Vancouver, Canada. The meeting included presentations by FDA and Health Canada.
 
In the US, comments on the guideline focused on clarity on rifampin and stakeholders wanted more information on biomarkers. (RELATED: ICH M12: Pharma industry wants clarity on rifampin dosing, more information on biomarkers, Regulatory Focus 7 October 2022)
 
Public meeting