FDA’s regulatory assessment has evolved from a summary-based review to a question and risk-based review with an integrated quality assessment. Over the years, the FDA has focused on the challenges of efficiency, consistency, and objectivity in its oversight of pharmaceutical quality. To address these challenges and to take advantage of emerging technology, the FDA is developing a new system called Knowledge-aided Assessment & Structured Application (KASA).
The KASA system is designed to:
- Efficiently and appropriately assess the Chemistry, Manufacturing & Controls (CMC) information contained in applications
- Enhance risk management and risk-based regulatory decisions
- Optimize computer-assisted knowledge management throughout the lifecycle of the product
- Reach consistent, logical, efficient, and risk-based regulatory decisions and improved communication of these decisions to stakeholders.
Potential implications to the industry:
- Potential change to the eCTD layout, which is currently unstructured, doesn’t follow product development workflow, varies in detail and is in PDF format that cannot be searched/mined.
- Relying on sponsors to submit applications with CMC data and information in the correct sections of the eCTD.
- Future submissions could interface with the KASA system and autopopulate information, which could alter the layout of Module 3.
- FDA will have full oversight of regulatory history and so will not review changes in isolation. This will deliver more efficient approval of lifecycle maintenance changes.
There is no current timeline for the roll out of KASA and it is anticipated that this will take a number of years to develop. The first step will be draft guidance for industry comment. Kinapse will be following progress and will update our clients as the initiative evolves.