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 Recommendations page was last updated on August 28, 2008.
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 ICSR page was last updated on October 25, 2005.
A
revised specification has been developed and is being provided for public
awareness. It will be open for comment until 22 July 2009. Full
details are provided on a separate ICSR – Public
Awareness page. [This page was created on June 26,
2009.]
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 eCTD page was last updated on June 26, 2009.
The most recent Specification developed by the M2 EWG is the Study Tagging File (STF) Specification. The STF is supplemental to the eCTD. The STF page was last updated on January 6, 2009.
| Last updated: June 26, 2009 |