ATTACHMENT ⅡPDG Document Submission Provided for ICH Q4B EWG Evaluation

This is an example of a document submission from the PDG : The Coordinating Pharmacopoeia , on behalf of PDG , is asked to provide , as soon as possible after PDG Stage 5B signoff and usually within six months .3 ) The texts as intended for adoption and publication in each pharmacopoeia together with a statement of any local differences with respect to the sign-off text .If any changes occur or additional differences are discovered after submission to Q4B for evaluation , the Q4B EWG should be informed promptly by the pharmacopoeia concerned .