Question

Your company, DrugsRUs, has developed a generic angiotensin-converting-enzyme inhibitor, Vasotec, as a pharmaceutical drug used primarily for the treatment of hypertension and congestive heart failure. You are leading the regulatory strategy team and have been asked to describe the path to approval comparing introduction in the US versus Brasil.

Please discuss the following:

(1) Which agency or agencies will be responsible for approving/reviewing your Vastec drug: (a) before commercial introduction, and (b) after approval for commercialization/sale within the US., and

(2) Compare known issues your company will need to consider to market your generic drug is Brasil.

Answer 1

1a) In US , The food and drug administration (FDA) regulates which drug will get the approval and which not. It has six center, one of it is Center for Drug Evaluation and Research (CDER). To market a new drug, the companies requried to make an application-New drug application (NDA) and Abbreviated New Drug Application (ANDA). Next the application is reviewed by CDER and after this the new drug will get acceptance or rejected. b) once a drug comes in the market and available in the counter, it will further also be regulated by FDA.

2) In Brazil, The federal regulatory agency, National Sanitary Vigilance agenc (ANVISA) is regulating the registration of pharmaceutical drugs. When a new drug wants to come in the market of Brazil, it will need to make registration with ANVISA. To make this regristration, the company which is making the drug will apply through its local office in Brazil. Once the registration is done, it will be valid for 5 years, and after this it is necessary to reniew the registration.