Regulation Lag

Abstract

At a late stage in the preparation of this book information has become available on application dates for a number of drugs in the sample population. This information permits a direct measure of the time taken for drugs to obtain clearance through regulatory systems. The major deficiency of the procedure so far has been the use of marketing dates. The diffusion lag has been defined as the difference between the first marketing of a drug and subsequent introduction times elsewhere. Such a measure does not identify the total time taken to spread to other countries nor does it determine the regulatory component in the transmission process. Great care has had to be taken to remind readers that the reduction in diffusion lags throughout the sample period does not mean that drugs now spread around the world faster. It is tempting to draw such a conclusion but in fact this would be improper. However the new data changes things considerably. Some reasonably precise information is now available to measure regulatory lags. This permits factual answers to a whole series of questions. These include: Does regulatory clearance take longer now than in the 1960s? Is regulatory delay related to the stringency of registration systems? Is the total time taken for drugs to spread between countries shorter or longer now than in the 1960s? These questions will be the concern of this chapter.