REGULATORY ASPECTS CONCERNING GENERIC DRUGS APPROVAL IN “BRICS” COUNTRIES

Meghana Mylapur* and Prakash S. Goudanavar

ABSTRACT

Five significant emerging markets—Brazil, Russia, India, China, and South Africa—join forces to form the BRICS. It's important to protect the Businesses regulated by the pharmaceutical industry that are required to adhere to all applicable rules and regulations, which are enforced by regulatory bodies, for the safety and well-being of the general population. Depending on center entry, regulatory constraints might vary from one to the next. Because of this, it is difficult for pharmaceutical companies to develop a single treatment and obtain simultaneous market approval in several countries. Making sure that products are produced in line with the regulatory requirements of the regulatory body is one of the major problems it faces in the country where they are sold. BE studies must be carried out entirely against Brazilian inventors at centers that have been approved by ANVISA promptly in order to meet ANVISA regulations. It's likely that the process for submitting dossiers will change in the future. For instance, Russia will start using EU procedures in 2020, but South Africa will start adopting eCTD for the submission of dossiers in 2017. The requirements differ from one nation to another and depend on how the dossier is filed. In addition to examining and evaluating the legislative requirements that vary among these five countries. This Review article's purpose is to focus attention on the changes in dossier submission that have made it possible to submit many dossiers simultaneously.

Keywords: BRICS, CDSCO, ANVISA, Regulatory, Registration, Generic Drugs.