Pharmaceutical Product Registration and Requirements in CIS Countries

Authors

  • Rahman F. Department of Regulatory Affairs, NGSM Institute of Pharmaceutical Science, NITTE University, Mangalore, Karnataka, India
  • Dixit M. Department of Regulatory Affairs, NGSM Institute of Pharmaceutical Science, NITTE University, Mangalore, Karnataka, India
  • Charayulu R.N. Department of Regulatory Affairs, NGSM Institute of Pharmaceutical Science, NITTE University, Mangalore, Karnataka, India
  • Daniel S. Department of Regulatory Affairs, NGSM Institute of Pharmaceutical Science, NITTE University, Mangalore, Karnataka, India
  • Rasheed A. Department of Regulatory Affairs, NGSM Institute of Pharmaceutical Science, NITTE University, Mangalore, Karnataka, India

DOI:

https://doi.org/10.37591/tdd.v1i3.266

Abstract

Commonwealth of Independent States (CIS) has been identified as one of the emerging markets due to the phenomenal growth of the pharmaceutical industry. It has estimated that pharmaceutical sector in Russia and other CIS nations with CAGR of 10–11% during the year 2012–2016. Russia holds 14% of CIS market in 2013 whereas pharmaceutical market in Ukraine and Kazakhstan contributed to 3–4%, respectively. The Federal Service for Surveillance in Healthcare and Social Development (Roszdravnadzor) is a regulatory authority of the Russian. The format for pharmaceutical registration is Common Technical Document (CTD). In 2010, India and Russia have signed a Memorandum of understanding (MoU) for cooperation in the pharmaceutical trade and industry and have implemented the same. Thus this paper mainly focuses on the registration requirements for CIS countries namely Russia, Ukraine and Kazakhstan and scope for Indian pharmaceutical industry in CIS market.

 

Keywords: Common Technical Document (CTD), International Conference
of Harmonisation (ICH), pharmaceutical, Memorandum of Understanding (MoU), CIS nations

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Published

2019-02-21

Issue

Vol. 1 No. 3 (2014)

Section

Review Article

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