An Overview on Pharmaceutical Regulatory Affairs Using Artificial Intelligence
Year: 2025
Type: article
Abstract: In order to improve productivity and creativity in drug development, the integration of artificial intelligence (AI) is the main emphasis of this article, which examines potential future paths in regulatory affairs. It discusses possible issues like algorithmic bias and prejudice related to the use of AI in legal systems. The authors examine the functions of numerous worldwide regulatory organizations in monitoring healthcare AI applications. The study also highlights the need for data management and structured content in Chemistry, Manufacturing, and Controls (CMC) regulatory submissions in order to optimize procedures. In the end, it promotes cooperation between interested parties to successfully negotiate the challenges of artificial intelligence in regulatory settings, guaranteeing fair access to cutting-edge medical treatments while reducing any prejudices.
Author: Vaishali Aher*, Mayur Pawar, Adesh Aware, Rahul Thosar, Sachin Valvi
Language: English
Subfield: Health Informatics
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W6911755685
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