Developing a Global Regulatory Strategy

Abstract

This paper addresses the development of a global approach to regulatory strategy. The globalization of regulatory affairs is still in its infancy, however, and, thus, while this paper describes a number of systems and projects undertaken by Marion Merrell Dow (MMD) to aid in this process, as yet there is no practical proof that they work. On the other hand, harmonization is much more advanced in Europe and consequently the company does have considerable practical experience in developing and implementing a European regulatory strategy. This practical experience provides a valuable building block as MMD moves toward a global approach to regulatory strategy and has been drawn on in preparing this paper.