ABSTRACT
The drug development process is both long and complex. The average time from discovery to approval has been estimated to be 10 years. Throughout this process regulatory authorities play a significant role. Charged with the responsibility of ensuring the safety and efficacy of drugs and biological products that are approved for use, these regulatory bodies define the rules and regulations that guide industry in the drug development process. Through the issuance of policy and guidance documents as well as specific regulations, the regulatory authorities affect drug development from preclinical testing through registration and commercialization. The complexity of the development process is confounded by the varying regulations that exist from one country or region to another. This chapter outlines the drug approval process in the USA, the European Union (EU), and Canada, contrasting the rules and regulations that govern approval in these regions.
