The Regulations Concerning Adverse Reactions

Abstract

It is essential that the central organisation of a pharmaceutical company collects suspected adverse reactions associated with its products from all over the world. The laws in each country will differ and even minor differences in drug regulations will alter the quality and quantity of the adverse reactions reported to the central organisation. It is unrealistic to believe that the provision of a standard adverse reaction form and instruction to each overseas company will result in a homogeneous database. However, standardisation must be attempted. This chapter highlights the main regulations in the six most important world markets — United States of America, Japan, France, Germany, Italy and the United Kingdom. However, it is no substitute for the study of the original regulations, when appropriate. Since the United States is the most profitable market in the world, its requirements in the field of drug safety tend to dominate the thoughts of pharmaceutical companies.