End of the eCTD? FDA Pushes for New KASA System to Improve Assessments

Regulatory NewsRegulatory News | 20 September 2018 |  By 

The US Food and Drug Administration’s Pharmaceutical Science and Clinical Pharmacology Advisory Committee met Thursday to discuss the positive aspects of adopting a Knowledge-aided Assessment & Structured Application (KASA) platform.

As FDA Commissioner Scott Gottlieb discussed in June, the KASA platform aims to modernize generic drug reviews from a text-based to a data-based assessment. But Thursday’s discussion made clear that the KASA system may also be extended for use with new drug applications and even biologics license applications.

Larisa Wu of FDA’s Office of Pharmaceutical Quality (OPQ) further discussed the goals of a shift to KASA, noting that it could help the assessment of post-approval changes and the lifecycle management of drug products, among other positives.



Wu also noted the current challenges with the eCTD system that the agency currently uses, explaining how it does “not follow the development flow of the drug product,” and “contains unstructured data in text-based PDF files” that can lead to “redundancy and lengthy assessments.”

Other speakers talked about the way structured submission data could be pre-processed for reviewers to make it more uniform. Sponsor representatives on the committee offered their support for the work.

The committee voted 10-0 to the question: should FDA consider the enhancement of submission format to improve the efficiency and consistency of regulatory quality assessment? Committee members offered their unanimous support for the initiative, saying it will benefit both FDA and industry.

So, when are these changes coming?

FDA said it’s still in the internal development phase and does not have a timeline for rolling out structured submissions. A draft guidance would be released for industry to comment on the proposal before anything takes effect, FDA said.

And as far as converging with other international regulators, FDA officials Thursday said the European Medicines Agency is aware of FDA’s structured submission efforts, though some suggested FDA work with the International Council for Harmonisation.


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