ICH M2 ESTRI Main

The International Conference on Harmonisation (ICH) - Multi-disciplinary Group 2 (M2) Expert Working Group (EWG) was established during the ICH meeting 1994 in Brussels to facilitate international electronic communication by evaluating and recommending, open and non-proprietary - to the extent possible - Electronic Standards for the Transfer of Regulatory Information (ESTRI) that will meet the requirements of the pharmaceutical companies and regulatory authorities.

Due to the information technology (IT) nature of the topic, some of the activities of the EWG result in Recommendations. These Recommendations do not undergo the formal ICH step process to allow flexible change as both science, and technologies evolve. They are agreed in the EWG, signed by all parties of the EWG, and are approved and signed off by the ICH Steering Committee within the M2 Recommendation Notebook.

The first Specification developed by the M2 EWG to follow the Step process was the Individual Case Safety Report (ICSR), created as the electronic message for the ICH E2BM step 4 document version 4.4, Data Elements for Transmission of Individual Case Safety Reports.

The second Specification developed by the M2 EWG was the Electronic Common Technical Document (eCTD) created as the electronic message for the Common Technical Document developed by the ICH M4.

The most recent Specification developed by the M2 EWG is the Study Tagging File (STF) Specification. The STF is supplemental to the eCTD.

eCTD Version 3.2.2 and STF 2.6.1 published....