M2 Recommendations & Technical References

 

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 at their different meetings. The Recommendations are categorized as follows:

  • General
  • File Format
  • Information Transfer
  • File Integrity

Current M2 Recommendations Updated

Category

Title

Version

Date Endorsed

Implemented

EU

JP

US

CA

CH

General

Procedure

3.0

June, 2015

Yes

Yes

Yes

Yes

Yes

General

ESTRI Gateway

3.0

June, 2015

Yes

Yes

Yes

Yes

Yes

File Format

PDF

2.0

April, 2011

Yes

Yes

Yes

Yes

Yes

File Format

XML

1.0

November, 2005

Yes

Yes

Yes 

Yes

Yes

File Format

PDF/A

1.0

June, 2014

Yes

Pending

Yes

Yes

Yes

File Format

DOCX

1.0 June, 2015 Yes ** Pending Yes ** Yes ** Pending

Information Transfer

Genericode

1.0

June, 2015

Yes Pending Yes Pending Pending

Information Transfer

EDIINT AS1/AS2

2.2

June, 2010

Yes

Yes

Yes

Yes

Yes

File Integrity

MD5

1.0

June, 2010

Yes

Yes

Yes

Yes

Yes

File Integrity

SHA-256

1.0

June, 2015

Pending Pending Yes Pending Pending

** 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. 
  • 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.

Objectives

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 and personal messaging
  • File transfer to complement structured messaging
  • Directory services to manage and access data
  • Documents to handle heterogeneous data formats, like simple text, multilingual text, tables, graphics, pictures, and complex/compound documents
  • Formatted data for transferring information between heterogeneous databases (Electronic Data Interchange)
  • Information transfer to include secure messaging, secure structured transfer, and secure unstructured transfer

Approach

The M2 EWG takes the necessary steps to ensure that, despite their disparate needs, the different regions come to a consensus before those needs are factored into ESTRI Recommendations.

The international standards and commercial products were identified, evaluated, and tested in all regions to ensure interoperability and functionality essential for successful regional deployment. The process for harmonization was deliberate at building consensus and obtaining the commitment of all participating members to implement the agreed upon ESTRI Recommendations.

ICH M2 EWG pursued the challenging task of recommending international solutions by identifying the key areas (domains) that demanded M2's immediate attention.

ICH M2 EWG concluded that the best approach would be to recommend a technological framework consisting of open international standards and interoperable products, or to identify proprietary solutions that are de facto standards, since the products offer all the required functionality.

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.

The establishment of common standards, especially at the international level, is a long, expensive, and complex process. This is mainly due to these fundamental needs:

  • to harmonize the disparate objectives and needs of different regions, cultures, and languages,
  • to negotiate and align all the participating entities towards common goals, and finally,
  • to obtain the commitment to implement the agreed upon standards.

ESTRI technical recommendations are generated through ICH M2 technical review and agreement by each party that the recommendation will be supported in the future. The ESTRI recommendations are designed to promote successful regional implementation.  Regions may implement restrictions for specific purposes.

 

 

Last updated: August, 2016