Table 1 Regulation and Legislation worldwide

In the U.S.A., the Food and Drug Administration (FDA) is responsible for the protection of the public health by assuring the safety, efficacy, and security of drugs, biological products, medical devices, food, and cosmetics. Based on federal legislation [4], the FDA develops several guidelines including for Good Clinical Practice (GCP).

In the European Union (EU), the European Commission (EC) is responsible for the initiation of new legislation, while the European Medicines Agency (EMA) is responsible for the scientific evaluation of medicines developed by pharmaceutical producers. The U.S.A., Japan, and the EU are also represented in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), which creates rules and guidelines for the development of new medicinal products.