Navigating Global Regulatory Requirements for Generic Drugs: A Comparative Study of MIST, BRICS, and ICH Countries

Bringing a new healthcare product to market can be challenging, especially when navigating the complex regulatory requirements of different countries. The approval process can be a maze of differing regulations, but this study provides a roadmap to success. This study aims to provide a clear and concise comparison of the regulatory dossier requirements of MIST and BRICS with ICH countries. The results of this study highlight key similarities and differences in their standards for quality, safety, efficacy, preclinical and clinical trials, and more. Whether you're looking to meet stringent requirements or find areas of alignment, this study offers valuable insights to help you bring your product to market with confidence. This comprehensive comparative analysis helps in succeeding in today's rapidly evolving pharmaceutical market.