The discussions around “unstructured data” vs. “structured data” in the context of pharmaceutical submissions have begun in earnest. The eCTD submission is essentially an unstructured narrative where the information presented does not follow the flow of product development. Furthermore, as an unstructured narrative, the onus falls on the regulators to sift through the information to ascertain the risks and associated control strategies. The sheer volume of information leads to more subjective reviews, reduces visibility to best practices across the industry, and challenges agency resources slowing down the approval process. The movement to a more structured narrative is logical given these challenges and the FDA is starting down this path now. Pharmaceutical companies should be thinking about how to manage their data and information in a structured format starting with their process development activities to stay aligned with the coming changes.
Yash Sabharwal
President & CEO, QbDVision
