ASIAN JOURNAL OF PHARMACEUTICAL SCIENCES AND RESEARCH COMPARATIVE STUDY: REQUIREMENTS FOR THE SUBMISSION OF GENERIC DRUG APPLICATION ACROSS US AND EU IN CTD/ECTD FORMAT

The major pharmaceutical markets in the world are United States and European Union, have different requirements for the registration of a pharmaceutical product. To harmonize the requirements as per the regulatory agencies, a concept of common technical and its electric version was implemented by ICH. As the CTD consists 5 modules; some modules are common to all regions. But there are still some differences in the requirements in the common modules as per the regional requirements. In this competitive world of Pharma generics, an attempt is made to highlight the difference between the two major countries registration requirements through CTD and eCTD format in this article.