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This article analyzes the post-approval change management systems in India and Japan, comparing them to the ICH Q12 guidelines aimed at harmonizing global practices. It discusses the challenges and impacts of implementing ICH Q12, which seeks to streamline the process of managing changes in pharmaceuticals and biologics while ensuring product safety and efficacy. The study highlights the importance of regulatory flexibility and risk-based classification of changes to improve efficiency in the pharmaceutical

Author

raja manikumar

Language

EN