Step 1 Consensus Building

The Regulatory Reporter prepares an initial draft of a guideline or recommendation, based on the objectives set out in the Concept Paper, and in consultation with experts designated to the EWG. The initial draft and successive revisions are circulated for comment, giving fixed deadlines for receipt of those comments.

To the extent possible, consultation will be carried out by correspondence, using fax and e-mail. Meetings of the Expert Working Group will normally only take place at the time and venue of the biannual Steering Committee meetings. Additional formal meetings of the ICH EWG need to be agreed upon in advance by the Steering Committee.

Interim reports are made at each meeting of the ICH Steering Committee. If consensus is reached within the agreed timetable, the consensus text with EWG signatures is submitted to the Steering Committee for adoption as step 2 of the ICH process.

When consensus is reached on the technical issues, all parties represented on an EWG would be invited to sign the document to indicate their agreement to the consensus text, which is then submitted to the Steering Committee. Circumstances could be envisaged, however, where not all parties are present or able to sign the consensus text. It would then be for the (Continued on next page)

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