REGULATORY TECHNICALITIES FOR DRUG PRODUCT REGISTRATION IN BRAZIL
Abstract
Brazilians are demanding better healthcare and modern medicines, presenting significant opportunities for foreign
investment. In Brazil, medicinal product registration is an extensive process. To do business in Brazil is not without
its challenges. Accessing the Brazilian healthcare market can be a major headache for many medium and small
companies without the resources and market knowledge to handle this highly regulated, technical, fragmented and
sometimes corrupt process. The Active Pharmaceutical Ingredient and excipients should be informed with their DCB
(Common Brazilian Denomination) number and administration, specifications, leaflets/labels, precautions, and
relevant information regarding the drug products must be submitted in Portuguese language in a dossier. The
registration process for medicine takes more than a year. In Latin America, Brazil, Argentina, and Chile are countries
which 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 geographic
location in America Latina and off course its emerging economy have proven to be enticing and promising as a
profitable market for many drug makers.
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