New Submission Format for KASA Regulatory Quality Assessment

Is it a right time to enhance the submission format for efficiency and consistency of Regulatory quality assessment? The outcome of recent discussions between USFDA (US Food and Drugs Administration) and the Pharmaceutical Science and Clinical Pharmacology Advisory suggests a positive sign. With the discussions, one can clearly make out that the FDA is exploring the positive aspects of adopting a Knowledge-aided Assessment & Structured Application (KASA) platform.

The recent update suggests that KASA provides an extensive database of information which is beneficial for FDA to assess risks related to the product quality and performance. The framework of KASA, is expected to overcome the unstructured text-based system. The aim of KASA platform is expected to modernize the eCTD by changing the reviewing practices from text to data-based assessment. Though, as per earlier discussions in June 2018, KASA was aimed at reviewing generic drug applications only, in a recent development it is learnt that the new platform can even be used for reviewing the new drug applications (NDA) and biologics license applications.

What benefits KASA is expected to offer:

  1. Improved consistency, transparency, communication and objectivity of Regulatory actions.
  2. Improved Regulatory evaluation and decision making.
  3. Reduced subjectivity of documentation and time burden.
  4. Improved quality and efficiency.

Though the Advisory is in complete favor of improving the submission format to increase efficiency of the Regulatory actions and suggests that it will be beneficial for both the FDA and the industry, the primary factor that the KASA plan is still in the internal development phase makes the applicants wait for more clarity. Before deciding on timelines for structured submissions, FDA intends to release a draft guidance for industry comments. Having said that, KASA as an alternative submission format for quality assessment remains as an unanswered question. Stay tuned for more updates on KASA platform. Be Informed. Be compliant.