ESTRI (M2, E2B, M5, M8)

The International Conference on Harmonisation (ICH) Multi-disciplinary Group 2 (M2) Expert Working Group (EWG) was established during the 1994 ICH Meeting 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 M2 EWG result in Recommendations. These Recommendations do not undergo the formal ICH step process in order 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 June 30, 2011.

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 was provided for public awareness on June 26, 2009. It was open for comment until 22 July 2009. A further revision to the specification was provided for feasibility testing on July 26, 2010.

A draft Implementation Guide (IG) for Electronic Transmission of Individual Case Safety Reports (ICSRs), Data elements and Message Specification was first provided for public awareness on June 26, 2009 and an updated version of the IG was provided for feasibility testing on July 26, 2010. In June 2011, a further updated IG finally reached Step 2, and was published for public consultation until March 2012. The IG is being updated to address the comments received from the public consultation and a final version of the IG will be published on the ICSR web page.

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 M4 EWG. The eCTD page was last updated November, 2012.

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 July 3, 2012.

The ICH M2 Expert Working Group (EWG) has initiated the development of the ICH eCTD v4.0 to improve robustness, flexibility and long term stability of the message. In accordance with the decision by the ICH Steering Committee that technical specifications should no longer be developed solely within ICH, but should be created in collaboration with Standards Development Organisations (SDOs), ICH eCTD v4.0 will be developed jointly with the HL7 Regulated Product Submission (RPS) project. The eCTD v4.0 Step 2 for Testing page was last updated November, 2012.