REGULATORY TECHNICALITIES FOR DRUG PRODUCT REGISTRATION IN BRAZIL
Journal Title: International Journal of Drug Regulatory Affairs - Year 2017, Vol 5, Issue 4
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.
Authors and Affiliations
Charmy Kothari, Shah Manan, Mohak Vaishnav
Keywords
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- EP ID EP329079
- DOI 10.22270/ijdra.v5i4.206
- Views 157
- Downloads 0
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