New Drug Application (NDA) Documentation: A Comprehensive Review from A Quality Assurance Perspective
Year: 2025
Type: article
Abstract: The New Drug Application (NDA) process is a critical component of drug approval, This review discusses the NDA process, key aspects from a quality assurance perspective, the need for contextualized documentation and regulatory frameworks, and the role of quality assurance in enabling successful drug approvals. The New Drug Application (NDA) is the principal regulatory pathway to gain approval for new pharmaceutical products before they can be marketed. It guarantees that a drug adheres to the rigorous safety, efficacy, and quality standards mandated by regulatory authorities, including the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Central Drugs Standard Control Organization (CDSCO), and the World Health Organization (WHO). Emerging trends in regulatory documentation, such as the adoption of electronic submissions (eCTD), artificial intelligence-driven regulatory reporting, and Quality-by-Design (QbD) principles, are also examined. The future of NDA submissions lies in strengthening data integrity, improving documentation accuracy, and fostering international regulatory harmonization. By implementing robust quality assurance measures, the pharmaceutical industry can enhance the efficiency of regulatory submissions and expedite the approval process for innovative therapeutic products.
Author: Rushikesh Kale*, Sakshi Kape, Rohit Karne, Satwik Kanade, Kalyani Kale
Language: English
Topic: Healthcare Regulation
Subfield: Health Information Management
Field: Health Professions
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W6968634721
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