ICH-M2 seeks multinational agreement on recommending electronic standards and solutions for industry and regulators.

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.

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 inter-operable 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.

Main | Background | Objectives | Approach | Recommendations 

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