Registration Process of Drug and Dossier Filing in Russia and Its Comparison with Others CIS Countries and India

Abstract

This study was aimed to prepare registration dossier for medicinal product in Russia by reviewing the guidelines of CIS (Commonwealth independent states) countries about the registration of generic products. CIS are group of countries which are formed in December, 1991 which unites Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan & Ukraine. Registration dossier is a set of documents which contains administrative, quality, nonclinical & clinical data of products. Dossier filling is a pre requisite criteria for getting marketing approval in any country. Aim of preparation of dossier is to acquire the knowledge of rules and regulations for filling a dossier, fees, and duration of registration time by regulatory authorities for giving a final approval. Data was organized and dossier was prepared as per the country specific guideline. After reviewing the guidelines of CIS countries it was found that Kazakhstan, Moldova & Ukraine follow the CTD (Common Technical Document) format so it is not complicated to file a dossier. Azerbaijan has most stringent requirement and complicated procedure that is why pharmaceutical firms avoid filing dossier in this country. Economically most viable countries are Russia and Ukraine among all the CIS countries. Regulatory requirements for the dossier registration in these countries are not stringent. So it is beneficial and preferable to file dossier for registration of pharmaceutical product in these countries. Dossier of parenteral product was prepared using country specific format for Russia, which is similar to CTD format of European Union (EU). Russia is an emerging market and now a day most of the developed countries want to create their dominance in emerging market. Therefor the filing of the dossier will help for easier and fast availability of drug product in market of Russia.