Pharmaceutical Regulation in the European Union

The main scientific and technical aspects of new drug registration, including pathways to marketing authorization approval, clinical study design and method, and requirement of and specifications for Good Clinical Practice, Good Laboratory Practice, and Good Manufacturing Practice, are all quite similar between Europe and the United States. Differences do exist, however. This chapter provides a closer examination of the drug regulatory regime in the European Union. After providing a brief history of the European Medicines Agency, the chapter examines the agency’s organizational structure and role in ensuring the safety and efficacy of pharmaceutical products for Europe, and discusses the regulatory pathways for generics and biosimilars in the EU. The chapter also looks at recent trends in international drug approval lags.