Artificial intelligence in pharmaceutical regulatory affairs.

Journal: Drug discovery today
Published Date:

Abstract

Artificial intelligence (AI) refers to the ability of a computer to carry out tasks associated with human intelligence, including thinking, discovering, and learning from prior experience. AI can be integrated to simplify the complexity of pharmaceutical regulatory affairs. AI tools can be applied to automate regulatory processes such as administrative work, dossier filling, data extraction, auditing, the implementation of regulations, and quality management. AI creates process links and reduces complexity, resulting in a more efficient management system. Human-AI interaction opens up new opportunities in regulatory affairs. This article explores the potential role of AI in pharmaceutical regulatory affairs.

Authors

  • Ruchika S Patil
    Department of Drug Regulatory Affairs, BVDU Poona College of Pharmacy, Pune 411 038, Maharashtra, India.
  • Samruddhi B Kulkarni
    Department of Drug Regulatory Affairs, BVDU Poona College of Pharmacy, Pune 411 038, Maharashtra, India.
  • Vinod L Gaikwad
    Department of Drug Regulatory Affairs, BVDU Poona College of Pharmacy, Pune 411 038, Maharashtra, India; Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research (NIPER), Hajipur 844 102, Bihar, India. Electronic address: vinod_gaikwad29@yahoo.com.