Retrospective Evaluation of Company Responses To Literature Inquiries By a Regulatory Authority

OBJECTIVES: This study aims to critically evaluate the adequacy and regulatory compliance of company responses to literature inquiries made by the SFDA. It identifies gaps in current practices and proposes recommendations to enhance the quality of future submissions.

METHODS: A retrospective document analysis was conducted, reviewing all literature inquiries and corresponding company responses filed in the electronic Common Technical Document (eCTD) from January 2021 till November 2023. Data of product submissions were collected from the Saudi Drug Registration (SDR) and Extedo Universal Review System (EURS). Descriptive analysis was performed to assess the current literature review inquiries and company responses in terms of number of inquiries, type of products, submitted evidence, search strategies, and decision outcomes related to these submissions.

RESULTS: Among 28 evaluated products, 15 met the inclusion criteria. The companies responded to 18 inquiries as three products had at least two inquiries. Nine products were generics compared to six new products from known active substance. Despite most literature inquiries satisfying SFDA requirements, substantial gaps were observed in company compliance. Approximately 80% of the responses predominantly supported the active ingredient's efficacy and safety for the proposed indication, but 40% demonstrated limited search breadth. Furthermore, over half of the responses lacked explicit search strategies.

CONCLUSIONS: The study reveals a significant discrepancy between the expectations of the SFDA and the quality of company responses to literature inquiries. The findings suggest an urgent need for regulatory guidance specific to literature reviews, aiming to standardize and improve the quality of submissions.