Registration Requirements of Parenterals in Ukraine and Its Comparison with Other CIS Countries

Abstract

This study was aimed to prepare registration dossier for parenteral product in Ukraine by reviewing the guidelines of CIS countries about the registration of generic products. Registration dossier is a set of documents which contains administrative, quality, nonclinical & clinical data of products. Commonwealth independent states (CIS) are group of countries which is formed in December,1991 which unites Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan & Ukraine. Dossier filling is a pre requisite criteria for getting marketing approval in any country, My attempt in preparing this dossier is to acquire the knowledge of rules and regulations for filling a dossier, fees, and time taken by authorities for giving a final approval. As per ICH guidelines, dossier for parenteral product should include the data described in module 1, 2 and 3. Data was collected from the regulatory affairs department Administrative data), Analytical department (Quality data), Preclinical department (Nonclinical data) & Clinical department (Clinical data) from of the Cadila Pharmaceutical Limited. 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 format so it is not complicated to file a dossier. Azerbaijan have most stringent requirement and complicated procedure that is why pharmaceutical firms avoid filing dossier in this country. Economically most viable countries are Ukraine and Russia 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 was prepared as per the CTD module as demanded by Ukraine guidelines. As dossier was prepared for parenteral product which exempts the submission of module 4 and 5, therefore prepared CTD contains module 1, 2 and 3 satisfy all the regulatory requirements for the filing of parenteral product. Ukraine is a emerging market and now a days 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 Ukraine.