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Abstract

Comparative Study of Process of Post Approval Change Application Submission and Approval for Marketing Authorization Variations in EU, US, India, Saudi Arabia and Singapore

The present research endeavors to shed light onto the role that post approval change management in overcoming non-compliance. The present study has focused on identifying the existing policies and procedure in this area and understanding the underlying concepts for post approval compliance for licenses pertaining to marketing authorization. The study compared and contrasted policies and procedures of regulatory authorities in India, US, EU, Saudi Arabia and Singapore. The major finding of the study indicates that though change management plays a crucial role in the lifecycle of a pharmaceutical. However, lack of defined framework coupled with lack of comprehension of the same has increased the cost of compliance resulting step-motherly treatment being mitigated towards compliance and license maintenance. The initiatives by the ICH with drafting of ICH Q12 guidelines is a welcome step forward and may help the pharmaceutical industry to comply with the regulations.


Author(s): Lokesh M.S, N. Vishal Gupta, Bhushan Dinesh Belagoankar

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