M2 Recommendations & Technical References

About M2 EWG

The M2 EWG was established in 1994 to facilitate electronic communication between pharmaceutical companies and regulators.

Original Objectives

• Recommend technologies and standards that create measurable time and resource savings for both industry and regulators
• Recommend non-proprietary Electronic Standards for the Transfer of Regulatory Information (ESTRI)

Current Remit

• ICH topic assessment
  • Make recommendations on transport, format, and security of information; and technical evaluation of EWG materials.
• Consultative support
  • Provide technical consultative support to other EWGs.
• SDO relationship management
  • Manage the interface between ICH and Standards Development Organizations (SDO) like ISO/TC215, HL7 and EDQM.
• Technology and Regulatory Trends
  • Gather and evaluate intelligence on technology and regulatory trends.

Technical Recommendations

The M2 EWG has provided valuable functionality to the diverse international information exchange needs identified by the members of the ICH regions and observers. The M2 EWG Recommendations provide a well-defined approach for the evaluation and recommendation of standards. The M2 tasks have led to the recommendation of various open international standards that allow for the international transmission of information regardless of the technical infrastructure.

The recommendations have been endorsed by the ICH Steering Committee / ICH Management Committee and Assembly. The Recommendations are categorized as follows:

• General
• File Format
• Information Transfer
• File Integrity

The process of developing the technological framework and recommending solutions followed the logical path of gathering requirements, assigning specific tasks, evaluating international standards and products, and recommending a functional architecture. The M2 EWG has developed a file format criteria document which describes required and desired aspects and functionality to be considered in the evaluation of a file format as acceptable for the exchange of regulatory information. This document is not intended to be a prescriptive set of criteria to be met.

Current M2 Recommendations

**Check with Regulator for specifics

Notes

• Technical terms in the above Recommendations are defined in the Glossary
• The previous categories "Physical Media" and "Network" have now been retired.
• See Recommendations Document History for details. 

Technical References and Information Papers

• OIDs - Recent ICH technical specifications (e.g., E2B(R3), eCTD V4.0) utilise unique identifiers such as OIDs and UUIDs to reference external content and entities (e.g., documents, organizations, controlled vocabularies, etc.). An information paper outlining the use of OIDs and UUIDs is available here.
• Redaction - Recently a number of regulatory authorities have produced guidance on the need to publish redacted versions of documents that they have received on their public websites. The intent of the redacted version is to remove from view information that may, for example, be of a personal nature or commercially sensitive. An information paper, entitled "Redaction: Points to Consider" is available here.
• PDF files  – To support electronic regulatory submissions in ICH regions a specification document (available here) has been developed that describes the way PDF files should be prepared. All ICH regional regulatory authorities are able to read and accept PDF files saved as PDF version 1.4 through 1.7 compliant to ISO 32000-1:2008. For regions accepting PDF/A, see chart above. Regulatory authorities should not need any additional software to read and navigate the PDF files.

Code list

(under construction)