Ranjini D.M, Sadiq Basha G, Prabakaran N.
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Ranjini D.M*, Sadiq Basha G, Prabakaran N.
1Regulatory Executive in Generic Formulation Regulatory Science, Biocon Pharma Limited, 20th KM, Hosur Road, Electronic City, Bengaluru, Karnataka 5600100.
2Associate Vice President – Regulatory Science Biocon Pharma Limited, 20th KM, Hosur Road, Electronic City, Bengaluru, Karnataka 5600100.
3Manager in Regulatory Sciences – Generic Formulations Biocon Pharma Limited, 20th KM, Hosur Road, Electronic City, Bengaluru, Karnataka 5600100.
Volume - 14,
Issue - 6,
Year - 2021
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.
Cite this article:
Ranjini D.M, Sadiq Basha G, Prabakaran N. Regulatory Strategies for Orphan drug Development in USA–Europe. Research Journal of Pharmacy and Technology. 2021; 14(6):3449-4. doi: 10.52711/0974-360X.2021.00600
Ranjini D.M, Sadiq Basha G, Prabakaran N. Regulatory Strategies for Orphan drug Development in USA–Europe. Research Journal of Pharmacy and Technology. 2021; 14(6):3449-4. doi: 10.52711/0974-360X.2021.00600 Available on: https://rjptonline.org/AbstractView.aspx?PID=2021-14-6-90
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