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Background
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Objectives

ICH-M2 Expert Working Group's (EWG) objective is to recommend multinationally acceptable standards.

Keeping in line with ICH's overall goal of harmonizing initiatives by delivering streamlined and more rapid information exchange, ICH-M2 recommends, to the extent possible, global technical standards that are supported by multiple vendors, affordable and mature, at low risk of obsolescence, and capable of providing the following functionality:

  • Structured messaging
  • File transfer to complement structured messaging
  • Directory services to manage and access data
  • Documents to handle heterogeneous data formats, like simple text, multi-lingual text, tables, graphics, pictures, and complex/compound documents
  • Formatted data for transferring information between heterogeneous databases (Electronic Data Interchange)
  • Security to ensure, if and when required, confidentiality, integrity, authentication, and non-repudiation.

Main | Background | Objectives | Approach | Recommendations

 Functionality | Meetings | Glossary | Future | Contacts