Enzymes are indispensable tools in the pharmaceutical sector as they are being explored as a part of biological medicines. These therapeutics proteins are available in a range of size and structural complexities, spanning from relatively simple proteins like insulin or growth hormone to more intricate ones such as coagulation factors or monoclonal antibodies. Enzyme replacement therapies have been recommended by FDA to address the various diseases. The utilization of enzymes in the pharmaceutical industry is projected to undergo sustained expansion, driven by the escalating demand for sustainable and eco-friendly manufacturing processes. Nevertheless, the pharmaceutical sector must confront several pivotal challenges to ensure the accountable and successful long-term incorporation of enzymatic technologies. As the demand for the utilization of enzymes in the pharmaceutical industry continue to increase, it is crucial to thoroughly assess and manage the inherent risks associated with their exploration and application. Robust biosafety guidelines must be implemented to address the potential risks and ensure the safety and efficacy of these biocatalysts. This chapter describes the regulatory framework on the usage of biological medicines such as proteins in pharmaceutical industries with a particular emphasis on risk assessment procedures and biosafety guidelines.