Call for cloud-based regulatory assessments

Laurence Yu, director of the Office of New Drug Products (ONDP) in the Office of Pharmaceutical Quality (OPQ) at the Center for Drug Evaluation and Research, made the remarks at a recent symposium on structured data submissions and drug master files, according to RAPS.

As part of the International Council of Harmonisation (ICH), Yu is instrumental in modernizing quality information that is submitted in the common technical document (CTD).

Yu explained that, although progress has been since the CTD and electronic CTD (eCTD) replaced paper submissions, there is still work to be done in modernizing the regulatory submission process.

Speaking of the role of regulatory in today’s digital age, Yu described the current submissions process as ‘outdated’. “First, the submission is a static snapshot in time versus individual documents … and is open to error.

“Second, it is cumbersome to extract and access PDF content, therefore the lengthy unstructured text narratives and the lack of efficient information exchange and knowledge management makes our system not only not efficient but not effective.”

It is believed that a cloud-based regulatory platform could improve uniformity and consistency across product reviews, by facilitating a more fluid exchange of information between companies, regulators, and industry.

Currently, the FDA is moving towards a cloud-based platform by way of internal and international harmonization initiatives.

The agency is also planning to launch additional elements of a cloud-like system for submissions and assessments via its Knowledge-aided Assessment and Structured Application (KASA) initiative. This was first announced in 2019 as part of the Commission’s efforts to improve and modernise the quality assessment of drug applications.

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