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Abstract

Post-approval Change Submission: ICH Q12 Impact Analysis on India and Japan

Author(s): S. Moorkoth* and T. Haldar
Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal-576 104, India

Correspondence Address:
Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal-576 104, India, E-mail: [email protected]


The present research provides a discussion on post approval change management of pharmaceuticals, biologics and drug device combinations, which is an important part of life cycle management. The present study focuses on understanding the existing post approval change management system in India and Japan. Comparison is then made with the elements and principles provided in draft ICH Q12 guideline. In November 2017 the draft guidance ICH Q12 entitled "Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management" has been published for comment. The discussion of this study would bring to light the key requirements, challenges and impact of future implementation of ICH Q12 in India and Japan. The initiative taken by ICH Q12 with this guideline focuses mainly on harmonizing the post approval system throughout the world which has the potential to reduce costs and time burdens for the regulators and industry.

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