Abstract
Before reaching the market, the last stage of development through which a new pharmaceutical compound must pass is regulatory review. This is one stage of the drug development process that is outside the direct control of the sponsoring company. Currently, both pharmaceutical companies and regulatory authorities are striving to increase the efficiency of the review process. For this reason, a study has been conducted to ascertain how long compounds are spending within this process.
Data on review times for compounds approved between 1990 and 1995 in at least one of nine major pharmaceutical markets (Australia, Canada, France, Germany, Italy, Japan, Spain, the United Kingdom, and the United States) have been studied. Analysis of these data has shown that review times are decreasing in the majority of markets. In 1995 the average review time was around two years in most countries, and in some cases, review times of six months were possible. There are still differences, however, in the time a compound will spend in review between authorities, even when the same compound is submitted in the same time frame.
In order to understand the reasons behind such differences, it is necessary to study a number of contributory factors. These include the quality of the dossier submitted, company response time to questions raised during the review, and the ability of authorities to manage the review both effectively and efficiently.
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