GUIDANGE ONGEOTXICTY ESTING ADDAT INERPTAION FRPHARMCEUTICALS INTEDD FORHUMAN USE2(R1)

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 Steering Committee to the regulatory authorities of the three ICH regions ( the European Union .Code as per the new codification system adopted by the ICH Steering Committee in November 2007.