Volume : 11, Issue : 06, June – 2024
Title:
COMPARATIVE ANALYSIS OF POST -APPROVAL CHANGE APPLICATION SUBMISSION AND APPROVAL PROCESS IN THE USA, EUROPE AND INDIA-REGULATORY INSIGHTHS
Authors :
G. Manasa, Mr. C. P. Sreekanth Reddy, Dr. K. Venu Gopal
Abstract :
The aim of this research is to examine the significance of post approval change management in addressing non-compliance issues. The study primarily focuses on identifying the existing policies and procedures in this field and gaining a deeper understanding of the underlying concepts related to post approval compliance for marketing authorization licenses. By comparing and contrasting the policies and procedures of regulatory authorities in India, US, EU, Saudi Arabia, and Singapore, the study reveals that change management plays a crucial role in the pharmaceutical lifecycle. However, the lack of a defined framework and understanding of this process has led to increased compliance costs and a lack of attention towards compliance and license maintenance. The introduction of ICH Q12 guidelines by the ICH is seen as a positive step that may assist the pharmaceutical industry in complying with regulations.
Key words: Product Life Cycle Management, Post Approval Changes, Non-Compliance, ICH.
Cite This Article:
Please cite this article in press G Manasa et al Comparative Analysis Of Post -Approval Change Application Submission And Approval Process In The Usa, Europe And India-Regulatory Insights .,Indo Am. J. P. Sci, 2024; 11 (6).
Number of Downloads : 10
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