Regulatory Strategy for Extending Mometasone Furoate Cream Dossier From U.S. to Brazil, Europe and India

Abstract

This work emphasis on the reverse engineering of already filed drug product in US and extension of that dossier to file the same product into regions like Brazil, Europe and India. Registration of drug product requires lot of documents showing the evidences that the product desired to get registered is of the required quality. Though basis of each regulatory structure is to establish quality, safety and efficacy of the drug product being marketed in its jurisdiction, each country differ in its procedure and guideline of drug registration. This makes the registration procedure a much complicated task. Even to register the same drug, there are variations in the pathway of registration of the drug product and the whole make up of dossiers for a particular country. Thus, it makes a time consuming process for Pharmaceutical companies to switch from one market to another. Agenda of this work is to understand the difficulties faced during switch over of a common product to different country & to outline the major gaps between requirements and registration procedures of different countries so that a regulatory strategy can be formed for extension of one dossier to another for the same drug product by understanding regulations and guidelines of US, Brazil, Europe and India and comparing the same on the grounds of administrative information, CMC and parameters for BE assessment of the drug products. To understand these regulatory differences between countries, an example of mometasone Furoate cream 0.1% has been taken which is a generic version of Elocon Cream 0.1% manufactured by Schering-Plough Corporation for which an ANDA dossier is filed first in US and then the same drug product is extended into Europe, Brazil and India.