In support of its conclusions, the M2 EWG has produced ten recommendations. Eight of these recommendations were endorsed in March of 1997, by the ICH Steering Committee at the meeting held in Narita, Japan.

Note:  The recommendations are PDF documents. To read the PDF files, download the free Adobe Acrobat Reader.

• General 1.1 - Procedure for Recommendations
• General 1.2 - Gateway Recommendation for the Electronic Transfer of Regulatory Information (ESTRI Gateway)
• General 1.3 - Core Standard Set
• Physical Media 2.1 -Floppy Disks
• Physical Media 2.2 - CD-ROM
• Network 3.1 - Messaging
• Security 4.1 - Secure EDI Transmission over the Internet (SMTP/MIME)
• Format 5.1 - Electronic Document Format

Recommendations 5.2 and 5.3 were endorsed in July of 1997, by the Steering Committee at the ICH-4 meeting held in Brussels, Belgium.

• Format 5.2 - SGML DTD Electronic Format for the Exchange of Individual Case Safety Reports (E2B Message)
• Format 5.3 - EDI Header Specification for the E2B Message.

Specifications for the electronic submission of  Individual Case Safety Reports (ICSR):

• DTD Version 1.0

• M2 Specification Version 2.24 DTD Version 2.0

• M2 Specification Version 2.3   DTD Version 2.1

Main | Background | Objectives | Approach | Recommendations
Functionality | Meetings | Glossary | Future | Contacts