2. GUIDELINES

The process begins with a document submission to the Q4B EWG . For PDG proposed pharmacopoeial text , the document submission should be provided as soon as possible after PDG Stage 5B sign-off ( refer to Attachment II ) .The document submission should outline any issues for resolution and should contain any appropriate supporting data .The Q4B EWG can revise the annex based on comments received and submits a final draft of the annex to the ICH Steering Committee .