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Objectives of the present work are as follows: • To study the current principles of rare diseases & orphan drugs. • To study the assessment, challenges and regulatory frame work of orphan drugs • To study the integrated approach for the development and approval of orphan drugs. • To carry out the study of globalization in orphan drug development strategies in US & EU markets. Methods: Internet using web page content: The literature was collected using numerous search engines e.g. Science Direct, Google Scholar and many more. Online books also served as a good source of information. Documents and information’s collected using numerous regulatory websites such as: a) USFDA: https://www.fda.gov b) EMA: https://www.ema.europa.eu/en c) CANADA: https://www.canada.ca/en/health-canada.html d) TGA: https://www.tga.gov.au/ e) INDIA: http://www.cdsco.com/ Results: US- FDA Approved Orphan Drug ex: Tafenoquine - Treatment of malaria - Krintafel is indicated for the radical cure (prevention of relapse) of Plasmodium vivax malaria. EU – EMA Approved Orphan Drug ex: Eculizumab, Soliris - Treatment myasthenia gravis. Conclusion: The orphan drug guidelines made via distinct countries have established as promoters in development of orphan drugs. The orphan drug regulation in the US and the EU has been a success in offering remedies to the patients with rare diseases.

My dissertation is grounded in policy issues that affect rural economic growth in emerging markets. In a global economic framework, where growth and redistribution are par for the course, policies promoting rural development deserve particular attention. In the first two chapters, I explore how property rights establishment affects trade, deforestation and agricultural productivity in the Brazilian Amazon. My third chapter presents substantial evidence that crises propagate differently across rural versus urban areas in Latin America.