The Interactive Digital CMC Regulatory Lifecycle (DCRL) Framework and Workflow
The Digital CMC CERSI presents The Digital CMC Regulatory Lifecycle (DCRL) Framework and Workflow.
The DCRL Framework and Workflow are tools for developers, users and regulators generated from a combination of well-established regulatory readiness levels, 5 Principles for digital tool adoption adapted from the MHRA’s 5 AI Principles and 10 Stages for digital tool development and adoption. The aims of these tools are to create a harmonised approach to support predictable, proportionate, and regulator-ready adoption of digital predictive tools across the CMC and product lifecycle. It is hoped this will increase developer confidence and facilitate alignment between academia, industry and regulatory bodies.
