INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED GUIDELINE CLINICAL ELECTRONIC STRUCTURED HARMONISED PROTOCOL (CeSHarP ) M11 TECHNICAL SPECIFICATION Step 3 Experts Draft At Step 2 of the ICH Process, a consensus draft text or guideline, agreed by the appropriate ICH Expert Working Group, is transmitted by the ICH Assembly to the regulatory authorities of the ICH regions for internal and external consultation, according to na tional or regional procedures.