Regulation & registration of drugs and biologics in Brazil

Nandini Pasam, Raju Kamaraj

SRM Institute of Science and Technology, Kattankulathur, Chengalpattu, Tamil Nadu, India

ABSTRACT

Registration of medicinal products is a challenging task in various countries as the regulatory requirements differ from country to country around the world. Like in regulated countries medicinal products regulation is a difficult piece of work in Semi-regulated countries as they are not coordinated. Being the sixth most populous country, Brazil gives a great opportunity for the bio/pharmaceutical market. Superior health maintenance, high quality, and modern medicines are being demanded by Brazilians which gives a huge opportunity for overseas investment. Medicinal products registration is a lengthy process in Brazil. Obtaining access to the marketing of drugs and biologics from the Brazilian Regulatory Authority is not an easy business for bio/pharmaceutical companies. One of the most difficult tasks facing regulatory agencies is ensuring that medications are manufactured in accordance with the country's regulatory requirements. This Review article's primary objective is to explain how pharmaceuticals and biologics are regulated and registered in Brazil.

Keywords:

Brazil, ANVISA, Drugs, Biologics, Regulation.