A Geocentric Approach to Pharmaceutical Research and Development and Drug Regulatory Affairs

Abstract

A new approach to world-wide pharmaceutical research and development and drug regulatory affairs is described. This new geocentric approach centers around a view of the entire industrialized world as an array of potential sites for research and development activities. Chosing specific sites for research and development activities involves detailed assessment of local regulatory affairs and economies-of-scale.

The geocentric approach represents a step forward from the legal and economic forces which have constrained the pharmaceutical industry through the decades of the 1960s and 1970s. In order to realized the full potential of this approach, the establishment of a multinational liason group between industry and governmental drug regulatory bodies is proposed.