Pharmaceutical Drug Regulations and Registration Process to Russia

Authors

  • Fijaz Rahman Department of Regulatory Affairs, NGSM Institute of Pharmaceutical Science, NITTE University, Mangalore, Karnataka, India
  • Mudit Dixit Department of Regulatory Affairs, NGSM Institute of Pharmaceutical Science, Nitte University, Mangalore, Karnataka, India

DOI:

https://doi.org/10.37591/tdd.v2i2.276

Abstract

Commonwealth of Independent States (CIS) has been identified to be one of emerging markets due to the phenomenal growth of the pharmaceutical industry. It has been estimated that pharmaceutical sector in Russia and other CIS nations with CAGR of 10 to 11% during the year 2012–2016. Russia holds 14% of CIS market in 2013. The choice of Russia as one of the destination for the market of the drug products ensures the manufacturer a good market value. Russia is considered as one of the strongest and promised markets for the registration of the drugs In Russia Roszdravnadzor, coming under the purview of Ministry of Health takes the decision to register the product and issues registration certificate. The format for pharmaceutical registration is common technical document (CTD). India and Russia have signed a memorandum of understanding (MoU) in 2010 for cooperation in the pharmaceutical trade and industry and have implemented the memorandum of understanding (MoU). Thus the paper focuses mainly on the registration process involved labelling of Russian Federation, regulatory authority of Russian Federation and scope of Indian pharmaceutical companies in the Russian market.

 

Keywords: Russia, CIS, MoU, CTD, dossier

Cite this Article

Rahman Fijaz, Dixit Mudit. Pharmaceutical drug regulations and registration process to Russia. Trends in Drug Delivery. 2015; 2(2): 8–18p

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Published

2019-02-21

Issue

Vol. 2 No. 2 (2015)

Section

Research Article

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