Regulatory Requirements for Registration of Generic Drug Product in Brazil

Abstract

Drug Product Registration is a procedure of expertise of the pharmaceutical products quality, efficacy and safety by Regulatory Authority. This present study focuses mainly on the marketing regulatory requirements for filing a generic product, the regulations that are applicable for the Pharmaceutical drug products. The emergence of various formats has enabled the manufacturers of the drug product, to easily gain access into various markets and thus, able to place their product into the market. The choice of Brazil as one of the destination for the market of the Drug products ensures the manufacturer a good market value. Brazil is considered as one of the strongest and promised market for the registration of the Generic drugs. The Brazil pharmaceutical market is the fifth largest in the world, worth around US$26.4 billion in 2013, according to Intercontinental Marketing Services-IMS Health.  The economic value, the Gross Domestic Product of the Brazil is indicates the stable drug product market it has. Of late generic drugs are holding major stake in the pharmaceutical market and are gaining more and more confidence in the usage. Majority of medicines in the Brazil are generic drugs which are considered as value for the money and affordable. In Brazil, National Health surveillance Agency i.e. ANVISA, takes the decision in the approval process of Drug product registration. The present work clearly explains the scenario of the Generic drug market in the Brazil. The market growth in this sector is promising; with many companies aiming to setup their facilities in this region the choice of market always remains a point of concern for manufacturer as the fate of the organization totally depends on the adaptability of the product in that market which results in profit.

Keywords: IMS-Intercontinental Marketing Services, ANVISA, Gross Domestic Product, Brazil, Generic drug Product

Cite this Article

Bengre Pallavi, Dixit Mudit, Dixit Rohit. Regulatory Requirements for Registration of Generic Drug Product in Brazil. Research & Reviews: A Journal of Drug Formulation, Development and Production, 2015; 2(2): 38–45p.