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 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 is now being published for public consultation. Full details are available on a separate ICSR – Public Consultation page. [This page was created on September 12, 2011 and updated November 29, 2011.]

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 November 29, 2011 .

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 June 24, 2010 .

ICH M2 has initiated the development of the Next Major Version of the eCTD (eCTD NMV) 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), the eCTD NMV will be developed jointly with the HL7 RPS project. M2 has developed this list of requirements as input into the HL7 RPS Project. The list of requirements was last updated on November 11, 2010.