The United States Food and Drug Administration (USFDA) has released detailed guidance"Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions" for industry, aimed at standardizing the electronic submission of data and information to support New Drug Applications (NDAs) and Biologic License Applications (BLAs). This guidance focuses on facilitating the planning and conduct of Bioresearch Monitoring (BIMO) inspections by ensuring that submissions are consistent, accurate, and timely.
This guidance outlines the standardized format for submitting clinical study-related information electronically to support FDA inspections. It applies to all pivotal clinical studies used to evaluate the safety and efficacy of drugs or biologics submitted under NDAs, BLAs, or supplements. Importantly, this guidance emphasizes the use of structured electronic formats to streamline inspection planning and review processes.
The guidance enforces section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which mandates that regulatory submissions, including NDAs and BLAs, must adhere to electronic submission requirements. It aligns with other FDA guidance documents, including those on eCTD (Electronic Common Technical Document) specifications.
Key Goals:
Improve timeliness in planning inspections.
Ensure data integrity and transparency.
Align with FDA's commitment to modernizing submission processes.
BIMO inspections focus on evaluating the integrity and compliance of clinical studies. The data required for these inspections include:
Clinical safety and efficacy data.
Subject-level information.
Documentation of compliance with Good Clinical Practices (GCPs).
Description of Required Data A. Clinical Study-Level Information
The FDA specifies three critical components:
Comprehensive Table of Clinical Sites: A detailed table listing all clinical sites, including investigator names, site identification numbers, addresses, and contact details, is essential for inspection planning.
Table of Contracted Entities: Sponsors must provide a list of all entities involved in clinical study activities, describing their roles and regulatory responsibilities.
Protocols and Case Report Forms: Protocol documents, amendments, and annotated case report forms for pivotal studies are essential for assessing study design and data collection.
B. Subject-Level Data Line Listings by Clinical Site
Subject-level data, organized by clinical site, should include primary and derived data points. This facilitates the verification of key study outcomes during inspections.
C. Summary-Level Clinical Site Dataset
The clinsite dataset aggregates data from all pivotal studies to characterize clinical investigator sites, describe study-level features, and summarize outcomes. This data supports risk-based site selection and prioritization for inspection.
All required data must be submitted electronically, and formatted according to the FDA’s eCTD specifications. Submissions should be organized under Module 5 (Clinical Study Reports) and uploaded through the FDA’s Electronic Submissions Gateway. By aligning with these requirements, sponsors can streamline their submission process while supporting the FDA’s mission to safeguard public health.
For more details, refer to the full guidance:
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