ABSTRACT
This chapter focuses on the conduct of biopharmaceutical research and development (R&D). It presents the main regulatory agencies for the approval of biopharmaceuticals globally are the US Food and Drug Administration, the European Medicines Evaluation Agency, and the Japanese Ministry of Health, Labour and Welfare. Their biopharmaceutical approval statistics belong to the public domain, and can supply the biopharma industry scholar with valuable insights into the industry’s R&D performance. A biopharmaceutical’s R&D stage is comprised of preclinical and clinical phases. The Health Policy Bureau handles promotion of R&D, and production and distribution policies, i.e., functions related to pharmaceutical companies. Rising costs have decreased the biopharma industry’s R&D productivity, eventually leading to questionable profitability. Biopharmaceutical companies, faced with decreased R&D productivity, are looking into new ways of shortening the times and reducing the investments required for preclinical and clinical development. The Tufts Center for the Study of Drug Development has even compared biopharmaceutical versus pharmaceutical R&D costs.
