This chapter describes the legal rules of pharmaceutical law that have to be followed when producing biotechnological drugs. Pharmaceutical law regulates everything that is relevant for safety, efficacy, quality and marketing of drugs. The chapter describes the good manufacturing practice (GMP) rules. Based on an overview of the fields of pharmaceutical law, the chapter focuses on the aspects relevant for manufacturing. Authorities and institutions and the most important rules issued by these bodies are described as well as official enforcement measures. The chapter provides an overview of the regulatory landscapes in the US, the EU, Germany as an EU member state, and Japan. In the US, the FDA represents a strong central authority bundling most of the functions of pharmaceutical surveillance. The chapter also gives a very short introduction to the basic terms of drug approval since these processes play an essential role when preparing for market launch.