The Q&A Procedure is followed when additional guidance is considered necessary to help the interpretation of certain ICH harmonised Guidelines and ensure a smooth and consistent implementation in the ICH regions and beyond. The additional guidance is usually developed in the form of Questions and Answers "Q&As".
The Q&A Procedure is driven by questions/issues raised by stakeholders, which serve as the basis for the development of model questions for which standard answers are developed. To assist the process, stakeholders are often invited via the ICH website to submit their questions on a specific Guideline.
The procedure is initiated with the endorsement by the ICH Assembly of a Concept Paper. In the case of major implementation activities, the Assembly may also consider the need for Business Plan. An Implementation Working Group (IWG) is subsequently established. The IWG works to reach consensus on a draft Q&A document and makes a recommendation to the Assembly on whether the document should be a Step 2b draft Document published for consultation or a Step 4 final Document published as final without consultation. This recommendation is based on the level of information provided by the answers.
The document then follows the normal path of a Step 2/Step 4 Document as per the Formal ICH Procedure.