4 December 2011

At their meetings in Seville, in November 2011, the ICH E2B(R3) and M8 working groups finalised further documentation related to the development of ICH electronic standards.

M8 eCTD: The Q&A document summarizing the results of the change request process for the eCTD Specification has been updated with five new Q&As, including four Q&As related to how to handle excipient sections. The updated document also reflects the withdrawal of Q&A #4.

E2B(R3) ICSR: The EWG finalised further supportive information to help the technical audience during the public consultation of the ICH E2B(R3) ICSR Implementation Guide. This includes: Reference Instance v2, updated with ICH OIDs; a set of lists of ICH OIDs and codes; and E2B(R3) OID Information Paper.

All documents can be downloaded from the eCTD page and ICSR – Public Consultation page of the ESTRI site, under ICH Work Products / Electronic Standards.