ICH M2 Electronic Standards Guidelines


M2 Electronic Standards

M2 EWG Electronic Standards for the Transfer of Regulatory Information

The M2 Expert Working Group (EWG) was established by the ICH Steering Committee in 1994 with the objective of facilitating 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.

Since its establishment the M2 EWG has been involved in a number of activities including: recommendation for use by ICH of various open international standards (M2 Recommendations); ICH development of specifications for electronic messages for the E2B(R2) ICH Guideline on Clinical Safety Data Management Data Elements for Transmission of Individual Case Safety Reports, as well as the M4 Common Technical Document (CTD); and the provision of technical input to the ICH E2B(R3) and M5 EWGs in their activities to progress their respective standards through the Standards Development Organization (SDO) process.

In November 2010, the ICH Steering Committee modified the mandate of the M2 EWG. Important changes included agreement that work related to the Electronic Common Technical Document (eCTD) be undertaken by a newly established M8 EWG, and that the M2 EWG would no longer be directly involved in the development of technical solutions in relation to topics such as E2B(R3) and M5, but would instead provide the framework for the efficient and effective development of the solutions by groups dedicated to these topics. Under its new mandate, the M2 EWG continues to be responsible for the evaluation and recommendation of standards, and also has responsibility for SDO relationship management.

Endorsed Documents (Click the links below for complete guidelines)

Related Links

*These Guidelines Belongs to ICH website.

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