Home / News & Events

Public consultations

You are invited to provide comments on any of the draft Step 2b ICH guidelines (see list below for current consultations).

Note that stakeholders from ICH Member countries/regions are encouraged to submit their comments directly to their respective Regulatory Authorities, noting the deadline for comments indicated beneath each draft Guideline.

Stakeholders can also provide their comments by e-mailing the ICH Secretariat at step2comments@ich.org. For this purpose please make sure to use the ICH Template in Excel format.

Please note that comments provided to the ICH Secretariat will be shared with the appointed participants of the relevant ICH Working Group responsible for the development of draft documents submitted for consultation.

Ongoing public consultations

E22 Public Consultation


Public consultation on the ICH E22 draft Guideline on General Considerations for Patient Preference Studies, released at Step 2b on 21 October 2025.
Visit Page

Recently closed consultations

Q1 Public Consultation


Public consultation on the ICH Q1 draft Guideline on Stability Testing of Drug Substances and Drug Products, released at Step 2b on 11 April 2025.
Visit Page

E21 Public Consultation


Public consultation on the ICH E21 draft Guideline on Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials, released at Step 2b on 14 May 2025.
Visit Page

E20 Public Consultation


Public consultation on the ICH E20 draft Guideline on Adaptive Designs for Clinical Trials, released at Step 2b on 25 June 2025.
Visit Page

Q3E Public Consultation


Public consultation on the ICH Q3E draft Guideline for Extractables and Leachables, released at Step 2b on 1 August 2025.
Visit Page

M4Q(R2) Public Consultation


Public consultation on the ICH M4Q(R2) draft Guideline, the revision of the CTD Quality module, released at Step 2b on 14 May 2025.
Visit Page