The ICH ESTRI Standards page (Electronic Standards for the Transfer of Regulatory Information � “ESTRI”:http://estri.ich.org ) was updated this week with several items of note resulting from the June 2015 ICH meeting. E2B (R3) issued a revised code list for �Route of Administration� and provided an updated document describing OIDs and UUIDs. The M8 (eCTD) group issued one new Q&A dealing with a Module 3 issue. But perhaps the most interesting news is the recommendation for DOCX as a submission file format (see “Recommendations”:http://estri.org/recommendations ). DOCX is an ISO standard and has the ability to contain custom embedded XML elements making it suitable for the submission of structured information. Regulators are now expected to provide plans for implementation.
August 26, 2015