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Revision Procedure (Category 3)
If an adopted guideline needs to be revised, then the formal ICH Step procedure should take place rather than the Q&A process. Any revision or modification to an existing ICH guideline should fall into the "Revision Procedure" category.
This procedure is almost identical to the formal ICH procedure (Category 1), i.e. 5 ICH Steps. The only difference compared to Category 1 is the final outcome: in Category 3, the final outcome will be a revised version of a current existing guideline, whereas in Category 1 the final outcome is a new guideline.
In some cases, during the process of creation of a Q&A document, the revision of the original guideline may be considered necessary. In this case, the IWG Rapporteur, when presenting the Concept Paper to the Steering Committee, may also request the setting-up of a EWG to discuss the document modifications. To increase efficiency, the same members as those forming the IWG may develop both the Q&A document and revise the guideline.
The revision of a guideline is designated by the letter R1 after the usual denomination of the guideline. When a guideline is revised more than once, the document will be named R2, R3, R4, etc at each new revision.