Risks and oppurtunities in development of new drug & question based review of regulatory compliance

Abstract

Pharmaceutical development is a costly, time exhausting and uncertain process that takes years to accomplish. In many instances, patent protection expires before a new drug is approved for marketing. Most pharmaceutical firms in the United States and European Union (EU) depend on the exclusivity rights allotted under the U.S. Federal Food, Drug and Cosmetic Act (FDCA), and the corresponding EU authorities to recover their considerable investment in the drug research and marketing approval process. Hence, pharmaceutical companies must understand and use the different   forms   of   non-patent   exclusivity   in both the U.S. and EU in order to win in the   global   marketplace. Pharmaceutical firms generally obtain patents on their products long before their product candidates are ready to enter market. Since it can take up to 12 years for a firm to obtain market approval, if any, patent protection left on the product at the time of commercializing. To provide pharmaceutical companies with a chance to recuperate their investment in drug research and development and to induce continuing innovation, the Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) have enforced numerous provisions to increase the period during which companies can market their drugs free of generic market competition.