An overview on comparative study of registration requirements for generics in US, Canada and Europe

  • Suryawanshi Meghraj Department of Pharmaceutics, Shree Dhanvantary Pharmacy College, Kim, Surat-394110 https://orcid.org/0000-0003-3958-2813
  • Jain minal Department of Drug Regulatory Affairs, Bharati Vidyapeeth (Deemed To Be University) Poona College of Pharmacy, Erandwane, Pune – 411038
Keywords: ANDA, ANDS, EMEA, US, Canada, Europe, Regulatory Registration Requirements

Abstract

Generic Drug Product approval is most stringent and crucial process for company with different rules and regulation in different country. For the registration of the product company has to follow regulatory rules and requirement of country specific agency. Company should apply product marketing authorization as per norms of country requirements and should manage life cycle of that product throughout market. Need to understand and describe the various regulatory requirements for the generic drug approval process and comparison of regulated country. To understand the technical requirements required to market medicines in regulated pharmaceutical market. To evaluate similarities and differences within regulated market of U.S, Canada, and Europe. To understand and evaluate differences of post approval Changes within regulated market.

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Published
02-07-2020
How to Cite
Suryawanshi Meghraj, & Jain minal. (2020). An overview on comparative study of registration requirements for generics in US, Canada and Europe. International Journal of Research in Pharmaceutical Sciences and Technology, 1(4), 117-123. https://doi.org/10.33974/ijrpst.v1i4.196
Section
Review Article