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Research Article

JCR. 2020; 7(19): 5290-5295


REGULATORY REQUIREMENTS FOR REGISTRATION OF DRUGS IN BRAZIL

Mr. Vignesh M, Dr. Ganesh Gnk, Ms. Sruthi N.

Abstract
One of the highly regulated industries is the pharmaceutical industries with more rules,
restrictions and regulations accomplished by the government to look after the comfort and prosperity of the
public wellness. In the current scenario regulatory requirements differ from the country to country around the
globe. Registration of drug products in the developing countries is a more challenging task, unlike regulated
countries as they are not unified. Brazilians are requesting better human services and current medications,
introducing huge open doors for outside ventures. In Brazil, restorative item enlistment is a broad procedure.
The economical implication of the developing market is growing universally. The preference given to the
International Council for Harmonisation (ICH) committee which is a precursor for the guidance universally in
the application of preparing drug dossier to integrate the quality, security and competent reporting
configurations. The role of investigators is stringent in dealing with the plant inspections right from the Active
Pharmaceutical Ingredient (API) or Drug Substance (DS) till the finished drug product specifications. The
registration process for the medicines takes over a year. In Latin America, Brazil, Argentina, and Chile are
nations which give consolation to nonexclusive item enrolment by limiting the enlistment charges for generics.
This review discusses about the registration, marketing authorization and regulatory requirements for marketing
the drugs in Brazil.

Key words: ANVISA, Requirements, Key challenges, Registration, Growth plan



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