The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has issued a Request for Information (RFI) for a "Global Post-Approval Chemistry, Manufacturing, and Controls (CMC) Collaborative Assessment Cloud Solution". This initiative reflects the ICH’s ambition to create a secure, scalable, and collaborative digital infrastructure to enhance regulatory processes for post-approval CMC submissions.
The RFI, published on 4 November 2024, invites input from stakeholders across the pharmaceutical and technology industries. It represents the next step in ICH’s multi-year Pharmaceutical Quality Knowledge Management (PQKM) initiative, which aims to modernize regulatory assessments globally.
The PQKM task force envisions a digital platform that facilitates real-time collaboration between regulatory authorities and pharmaceutical sponsors.
The solution will be implemented in phases, allowing for incremental improvements while scaling capabilities:
Phase 0 – Current State: Builds on existing pilot projects with decentralized processes and manual integration.
Phase 1 – Centralized Governance: Establishes a governing body and technical infrastructure for managing collaborative assessments.
Phase 2 and Beyond: Introduces advanced technologies such as artificial intelligence (AI), automated workflows, and enhanced data-sharing capabilities to support broader regulatory use cases.
By addressing regulatory convergence challenges, this solution is expected to:
Streamline Regulatory Processes: Centralize assessments of post-approval CMC submissions, reducing duplication of efforts by multiple regulatory bodies.
Improve Access to High-Quality Medicines: Enable faster and more efficient evaluations, mitigating risks of drug shortages.
Enhance Data Security: Implement advanced cybersecurity measures to protect sensitive commercial and regulatory data.
Promote International Collaboration: Provide a framework for synchronized regulatory assessments, fostering harmonization across regions.
The PQKM task force has outlined three core pillars for the proposed platform:
1. Business Process
The solution will streamline regulatory workflows, enabling sponsors to submit post-approval CMC data to multiple regulators simultaneously. Regulators will collaborate through a single interface, minimizing administrative burdens while preserving the independence of their regulatory decisions.
2. Solution Capabilities
The technology framework will include:
Workflow Automation: Tools for submission eligibility checks, automated document comparisons, and workload balancing.
Data Security: Compliance with global standards like GDPR, ISO 27000, and regional data residency requirements.
Collaborative Workspaces: Role-based access for regulators and sponsors, enabling secure document sharing and real-time communication.
3. Governance and Operations
A trusted third party will oversee governance, ensuring compliance with regional regulatory requirements and maintaining transparency. Over time, portions of the managed service may transition to the governing body.
The RFI seeks input on several critical areas, including:
Proposed architecture for the solution.
Strategies for ensuring compliance with regional regulations and data privacy standards.
Recommendations for integrating innovative technologies such as AI.
Approaches to scaling the platform for additional regulatory use cases.
Stakeholders are encouraged to submit their responses by 8 January 2025, with an information session scheduled for 18 December 2024 to address questions.
This initiative marks a significant step toward regulatory harmonization in the pharmaceutical industry. For more details, refer to the full RFI document here.