Regulatory Requirements for the Approval of Generic Inhalation And Nasal Products and Its Marketing Scenario in USA, Canada and EU
Pasumarthy N. V. Gopal2, Somepalli Mallikarjun*1, M. V. Nagabhushanam1, D. Nagarjuna Reddy1.
1. Department of Pharmaceutical Management and Regulatory Affairs, Hindu College of Pharmacy, Guntur, A. P, India-522002.
2. Department of Pharmaceutical Biotechnology, Hindu College of Pharmacy, Guntur, A. P, India-522002.
In this study work a comparative and differentiation has been put forwarded to make some recommendations of the regulatory framework. Now a day’s it’s too hard to invent a new drug so, the major pharmaceutical companies mainly depend up on the generic production of drugs. The generic drugs are very cheap when compared to innovator drugs in production cost and these generic products are customer friendly. . In this study the information was extracted from certain journals, text books, and related websites and from the authorized regulated authorities of the particular countries. The Topics covered in this study are introduction to regulatory affairs as well as regulated authorities in USA, CANADA and EUROPEAN UNION. About the data exclusivity and patent protection term information and the comparison among USA, CANADA and EUROPEAN UNION are enlisted in this topic. The comparison between the number of NDA approvals and ANDA approvals of USA, CANADA and European Union are represented statistically from 2006 to 2013 are labeled. The number of total molecule wise approvals in these countries is represented through pie charts and the top most pharmaceutical firms and their brand names of inhalation and nasal products are mentioned.
Keywords: Nasal Products, NDA, MAA.