DOSSIER FILLING AND COMPARITIVE STUDIES OF REGUALATORY REQUIREMENTS IN CIS COUNTRIES

The CIS region has an enormous growth potential market for India. The registration of the drug products in CIS regions is a challenging task because these countries have no harmonized regulatory organization. The CIS region includes 12 countries such as Russia, Kyrgyzstan, Ukraine, Uzbekistan, Kazakhstan, Tajikistan, Turkmenistan, Armenia, Azerbaijan, Belarus, Georgia and Moldova, which required different regulatory guidelines for medicinal product registration as per their FDA guidelines. The different guidelines for the same region become a challenging task for the manufacturer and exporter. The registration of the same product for different countries of CIS is not possible with the same dossier due to the lack of their regulatory harmonization. These countries obey their country-specific dossier format, so to target these market manufacturers and exporters needs to submit different dossier documents for different countries. But Ukraine and Kazakhstan have harmonization & it varies in Uzbekistan and Tajikistan. Ukraine and Kazakhstan are also getting strict & expecting USFDA level documents for approval

Key words: CIS, Dossier, Regulatory Authorities, USFDA