Regulations for Health Care Biotechnology Products in Major Markets of the World

Abstract

Biotechnology products have applications in many areas such as medicine, agriculture, energy, and environmental protection. Drugs and food supplements are amongst the major biotechnology-based products that cater to the health care sector. The products that are intended for use in diagnosing, curing, mitigating, or treating disease fall in the category of a drug and regulations are applicable to it. As a general rule of thumb, such products must subscribe to the best available science at the time. Regulatory authorities/systems are entrusted with the task of securing health of common people, as well as safety of subjects and environment while accelerating economic growth, innovation, competitiveness, and job creation. The regulatory agency has the responsibility to review laboratory and clinical research before approval of such products for commercial use. Similarly, products such as food supplements that are intended to prevent a disease or help in ameliorating a disease condition also require appropriate regulations. Although the general principles on which the regulatory guidelines are based remain almost the same, minor procedural and nomenclature differences exist in the regulatory agencies in various countries. In the present article, we provide specific and compiled knowledge of current regulatory procedures in the European Union (EU), USA, and India.