ICH Technology Platform Report: Secure Collaboration Requirements for Regulatory Harmonisation

Key Takeaways

• A single cloud-based platform hosted in Switzerland would enable secure, temporary sharing of commercially confidential information between Regulatory Authorities and industry sponsors to address critical gaps in ICH's current SharePoint and email-based workflows.
• The platform must incorporate encryption, role-based access controls, multi-factor authentication, and full compliance with data protection regulations, while ensuring permanent data custody remains with participating organisations.
• Stakeholder feedback confirms the platform would deliver significant value through enhanced regulatory consistency, proactive scientific leadership, and improved operational efficiency for global coordination.
• The ICH Management Committee must lead governance development, legal and IT consultation, financing, and procurement planning before issuing an RFP with clear Swiss law compliance requirements.

Why This Matters for Pharma Teams

For regulatory and cross-functional pharma teams, this report from the International Council for Harmonisation signals a potential future channel for confidential exchanges on guideline implementation and development. If advanced, the platform could support more consistent interpretation of ICH guidelines across regions, better alignment on scientific approaches to emerging technologies including digital health and artificial intelligence, and more efficient global coordination. The initiative also raises practical questions around access protocols, data handling procedures, and compliance obligations that sponsor organisations should monitor as governance structures are finalised.

What Gap Does This Address?

ICH's current SharePoint site functions as a basic file repository but lacks robust security protections required to handle commercially confidential information, trade secrets, and regulatory documents. Email-based coordination remains fragmented across time zones without standardised threading or status tracking. As regulators increasingly need to discuss specific industry data and harmonised guideline implementation approaches, the current infrastructure cannot support the secure collaboration necessary for ICH's mission in the 21st century.

What Are the Next Steps?

The ICH Management Committee is advised to undertake legal and IT consultation with participating jurisdictions, establish governance structures and financing mechanisms, develop operational policies and procedures, and prepare a Request for Proposal with clear Swiss law compliance requirements. An evaluation framework to monitor platform use and value should be established before procurement begins.

Frequently Asked Questions

Where would the platform be hosted and why?

The recommended model is a single cloud-based platform hosted in Switzerland. This location aligns with ICH's operational base and Swiss data protection frameworks.

Who would have access to the platform?

The platform would enable secure sharing between Regulatory Authorities and industry sponsors for ICH harmonisation work, with access controlled through role-based permissions and multi-factor authentication.

Would organisations lose control of their data?

No. The report emphasises that permanent data custody remains with the participating organisations. The platform serves as a secure temporary sharing mechanism only.

What specific security measures are required?

Security expectations include encryption, role-based access controls, multi-factor authentication, comprehensive audit trails, granular permission controls, and full compliance with data protection regulations across all participating jurisdictions.

Is the platform ready to launch now?

No. The Technology Task Force has completed its assessment and recommendations. The ICH Management Committee must now lead governance development, legal review, and procurement planning before issuing a Request for Proposal.