M2 Recommendations

The M2 EWG has provided valuable functionality to the diverse international information exchange needs identified by the members of the three ICH regions, Europe, Japan, and USA (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:

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 establishment of common standards, especially at the international level, is a ong, 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.

The M2 EWG has gone to great lengths to ensure that, despite their disparate needs, the different regions come to a consensus before those needs are factored into the Recommendations.

• The international standards and commercial products were identified, evaluated, and tested in all three 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.

Impact

The approved ESTRI Recommendations must be adopted by the ICH member parties. Though adoption need not occur immediately, the standards must be in place when the members implement electronic transfer. The ESTRI recommendations are designed to assure successful regional implementation.