Responses of Pharmaceutical Companies to Literature Review Inquiries from a Regulatory Authority: A Retrospective Analysis.
Author(s)
Zinah F. Alabdulkarim, B.Sc.Pharm, BCPS1, ?Ahmed F. Alkhaldi, MASc2;
1Saudi FDA, Senior Scientific Evaluation Expert, Riyadh, Saudi Arabia, 2SAUDI FDA, Director of Effectiveness and Safety Department, Riyadh, Saudi Arabia
1Saudi FDA, Senior Scientific Evaluation Expert, Riyadh, Saudi Arabia, 2SAUDI FDA, Director of Effectiveness and Safety Department, Riyadh, Saudi Arabia
Presentation Documents
OBJECTIVES: This study aims to assess the adequacy and regulatory compliance of company responses to literature inquiries from the Saudi FDA, focusing on the effectiveness of these responses in meeting regulatory expectations.
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 literature inquiries as three products had at least two inquiries. Nine products were generics compared to six new products from known active substance. Approximately 80% of the responses primarily supported the efficacy and safety of the active ingredients for the proposed indications; however, 40% exhibited a limited breadth of search in their supporting evidence. Additionally, more than half of the responses did not provide clear search strategies, indicating a need for improvement in the thoroughness of the submissions.
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.
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 literature inquiries as three products had at least two inquiries. Nine products were generics compared to six new products from known active substance. Approximately 80% of the responses primarily supported the efficacy and safety of the active ingredients for the proposed indications; however, 40% exhibited a limited breadth of search in their supporting evidence. Additionally, more than half of the responses did not provide clear search strategies, indicating a need for improvement in the thoroughness of the submissions.
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.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
SA48
Topic
Study Approaches
Topic Subcategory
Literature Review & Synthesis
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, STA: Generics