Comparative Overview of Regulatory Pathways for Generic Drug Approval in BRICS Nations

Abstract

Background: The pharmaceutical industry is highly regulated to ensure that the drugs delivered to the public are safe, effective and of good quality of the emerging economies in the world's major economies, BRICs countries, including Brazil, Russia, India, China and South Africa, have an important position in the pharmaceutical industry and the regulations associated with the pharmaceutical industry. Materials and Methods: Each country has its own National Regulatory Authority (NRA) that is responsible for laying down and enforcing regulations and guidelines to ensure the safety of public health. The regulatory bodies are responsible for the management and supervision of manufacturing and research activities of pharmaceuticals, approval and authorisation of pharmaceutical products and their regulations by various regulatory mechanisms applied to their day-to-day operations. Results: In view of the different regulations and requirements of submitting dossiers and evaluating in different countries, pharmaceutical companies face the challenges of getting simultaneous market approval of the same drug in different countries. Regulatory each drug must meet the regulatory requirements of the country where the drug is made or to be supplied. In Brazil, in order to comply with the regulations and needs of the ANVISA authority, Bioequivalence studies need to be conducted with Brazilian investigators from clinical trial that are approved and recognized by the authority. Nevertheless, it has been seen that the regulatory processes are slowly developing towards harmonization. Conclusion: For example, Russia has adopted the European Union-like procedures regarding dossier submission. South Africa has implemented the electronic version of the Common Technical Document (eCTD). It has been noticed that there is a constant change in the regulatory processes, which could open up opportunities in future.