Potential influence of international harmonization of pharmaceutical regulations on biopharmaceutical development

In the late 1980s, two independent efforts occurred that focused on reducing parallel regulatory requirements in different countries. These requirements had led to the need for duplicative testing to address a single issue when a single well-designed study would have been adequate to meet a sensible uniform requirement. One of these efforts was sponsored by the United States (US)-Japan Council, and included representatives of the US and Japanese pharmaceutical industries. The other effort was a series of exploratory discussions between the US Food and Drug Administration (FDA) and the European Union (EU) government body called the Committee on Proprietary Medicinal Products (CPMP), and later the Ministry of Health and Welfare (MHW) of Japan. In 1990, both of these efforts concluded with the promulgation of recommendations that arrived at the governmental centers of the developed world within several weeks of each other. It became clear to participants of both exercises and to other interested parties that a logical next step would be to involve the pharmaceutical industries and regulatory bodies of the three principal markets (Europe, Japan, and the US, which collectively comprise over 50% of worldwide pharmaceutical sales) in discussions to create a uniform set of regulations that would enable a single set of laboratory and clinical studies to meet regulatory requirements for market authorization of new pharmaceutical products in all three regions. Fulfillment of these uniform technical criteria for market authorization was widely believed to lead directly to a significant reduction in time and funding needed to secure worldwide marketing of a new drug.