Regulatory Frameworks Adopted by the US and EU for Bringing Complex Generics in the Market

Abstract

The regulatory requirements of complex generics in the USA and EU have similarities and differences in some ways which impacts the introduction of these products into the market. Thus, this article focuses on a comparative study of the approval procedures, requirements for bioequivalence, regulatory guidelines, preclinical and clinical data, post-approval data, quality and safety standards, flexibility and the user fees for drug applications between both the USA and the EU. Due to the current situation, there has been a need to come up with harmonized regulations, and guidance documents for the authorization of complex generics. The regulatory approval of complex generics in the USA is through filing an Abbreviated New Drug Application (ANDA), which is a fast and flexible method. EMA uses a Centralized Procedure which has high quality and safety requirements and is more costly and time-consuming as compared with the FDA. Thorough pre-clinical and clinical studies of complex generics are requested by the FDA and EMA to ensure the safety and efficacy of these products. This helps in promoting the global market, affordable costs, and availability of complex generics to the patients. This study is useful for manufacturers, regulators, and others who are involved in developing and regulating complex generics.