Multinational and International Regulation of Pharmaceuticals and US Policy

Abstract

The availability world wide of safe and effective drugs requires the joint efforts of pharmaceutical manufacturers and national drug regulatory agencies. Communication and cooperation among these agencies and between national drug agencies and multinational organizations can facilitate the introduction of important new drugs and hasten the removal or restrictive labeling of drugs that are found to cause serious safety problems. Uniform regulatory requirements may be desirable from the point of view of efficiency; they could dramatically increase the speed by which new drugs are introduced and new drug technology transfers from country to country. Such a goal is Utopian, however. Each sovereign nation has its own national health policies and needs that must be considered in its drug regulatory program. Effective communication among regulatory agencies brings the facts of issues to bear quickly and permits each country to make its own decision on the issue with minimum delay. The Food and Drug Administration has been a leader in stimulating communication and cooperation among international drug regulatory agencies. Through regular meetings with representatives of foreign drug regulatory agencies and multinational organizations involved in drug regulation, matters of drug regulatory policy are considered. This paper reviews the framework of US relations with international and multinational drug regulatory agencies and discusses US positions on pharmaceutical exports, the proposed Pharmaceutical Marketing Code, and the proposed Scientific Document Scheme.