REGULATORY TECHNICALITIES FOR DRUG PRODUCT REGISTRATION IN BRAZIL

Abstract

Brazilians are demanding better healthcare and modern medicines, presenting significant opportunities for foreigninvestment. In Brazil, medicinal product registration is an extensive process. To do business in Brazil is not withoutits challenges. Accessing the Brazilian healthcare market can be a major headache for many medium and smallcompanies without the resources and market knowledge to handle this highly regulated, technical, fragmented andsometimes corrupt process. The Active Pharmaceutical Ingredient and excipients should be informed with their DCB(Common Brazilian Denomination) number and administration, specifications, leaflets/labels, precautions, andrelevant information regarding the drug products must be submitted in Portuguese language in a dossier. Theregistration process for medicine takes more than a year. In Latin America, Brazil, Argentina, and Chile are countrieswhich provide encouragement for generic product registration by discounting the registration fees for generics.Regardless of the challenges and qualms, Brazil’s diverse population of nearly 200 million people, their geographiclocation in America Latina and off course its emerging economy have proven to be enticing and promising as aprofitable market for many drug makers.