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Abstract

OVERVIEW OF REGULATION OF MUTUAL RECOGNITION PROCESS AS PER UNITED STATES, EUROPE, JAPAN AND SWITZERLAND

*Dhara B. Bhatt, Pooja D. Patel and Dr. Dilip G. Maheshwari

Abstract

The Mutual Recognition is an effective way to ensure equivalency of “Good Manufacturing Practice” compliance Programme between different courtiers. The recognition process pre suppose the joint exercises to determine high standards of product safety and quality in order to increase communication between regulatory systems. This provision is applicable for all medicinal products manufactured in with GMP compliance, imported and exported to any regulatory authorized country. This paper high lights the regulatory requirements of United States, Europe, Japan and Switzerland for mutual recognition of medicinal products to establish working collaborative and strategical working to help ensure that patients have access to safe, effective and high-quality and more affordable medicines by minimizing duplication of inspection with better compliance activity.

Keywords: Mutual Recognition, Agreement, Regulation, GMP, Medicine


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