Regulatory Affairs: “Study Report of New Drug Registration Process in European Union”

Abstract

European Union is the big market for pharmaceuticals. Every pharmaceutical company wants to starts their business in European Union. In European Union come different countries like UK, Germany, France, Ireland, Sweden etc. In these countries various different process for new drug registration process like Nationalize process, Centralize process, Decentralize process, Mutual recognition process. Before that clinical trial approval also important for new drug registration. New drug registration process in European Union takes approximately 33 to 35 weeks. Each company must follow the rules and regulation for new drug registration. European medicine agency which gives the Clinical trial authorization and Marketing authorization to the new drug.