The US Food and Drug Administration (FDA) has been developing a new pharmaceutical quality assessment system known as the Knowledge-aided Assessment & Structured Application (KASA).
This new system is designed to:
- capture and manage knowledge during the life-cycle of a drug product;
- establish rules and algorithms for risk assessment, control, and communication;
- perform computer-aided analyses of applications to compare regulatory standards and quality risks across applications and facilities;
- provide a structured assessment that minimises text-based narratives and summarisation of provided information.
The current system used by the FDA is the Electronic Common Technical Document (eCTD), which is said to have many flaws. When a quality assessor reviews regulatory applications using eCTD, “it is not possible to easily locate historical data about similar products, processes or facilities. Such a practice has significantly reduced the efficiency of the regulatory assessment and increased the likelihood of inconsistencies. In particularly urgent cases, the FDA may not have readily available up-to-date information to provide timely, thorough, and complete responses, hindering FDA’s regulatory oversight”.
According to the FDA, when fully developed, KASA will “enrich the effectiveness, efficiency, and consistency of regulatory quality oversight through life-cycle management of products and facilities, and information sharing in a standardized and structured format”. Their aim is to help to alleviate problems associated with electronic drug applications. Overall, KASA should improve pharmaceutical quality, thereby ensuring the safety and efficacy of drugs and assuring patient-focused quality standards.
FDA have not provided a timeline for the roll-out of KASA however they will release a guidance for industry feedback before anything is actioned. The European Medicines Agency (EMA) is aware of the proposed plans for this new system but there have been no discussions regarding international harmonisation. Our recommendation for companies developing products for the American market is to monitor the situation and look out for any updates from the FDA. We will also write about any updates on our website as soon as they are published.
To read more about the FDA’s plans for KASA, click here.