Investigating the Rules and Regulations of the Registration Process of Pharmaceutical Products in the Common Wealth of Independent States (CIS) in Comparison to Those in Iran

Abstract

Background: Drug Dossier is a file document submitted based on the requirement of the drug approval process. It is a comprehensive scientific document used to obtained worldwide licensing approval of a drug by diverse health authorities. There are different requirements in different countries for registration of a product. Regulatory agencies require Pharmaceutical Dossiers to gain approval to market drugs. Drug Dossier is a document file which has technical and administrative information. Pharma companies prepare dossier as per CTD / Eu CTD / non-CTD (country specific guideline). Methods:  This dissertation is completely descriptive and it is enough to collect, translate and classify the registration process of the countries under study. Finally, its key steps are compared with Iran's regulations, as well as some guidelines for developing exports in accordance with the regulations of the countries under study. Results: CIS countries follow their own country specific dossier format. Documentation of Dossier in countries of the CIS countries is different from Iran.