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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 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 to consultation.

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