A Study of Trends in Pharmaceutical Regulatory Approval Times for Nine Major Markets in the 1990s
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Drug Information l o u d , Vol. 32, pp. 7 8 7 4 0 1 , 1998 Printed in the USA. All rights reserved.
A STUDY OF TRENDS IN
PHARMACEUTICAL REGULATORY APPROVAL TIMES FOR NINE MAJOR MARKETS IN THE 1990s KATE E. THOMAS,BSc, MSc Research Associate
NEILMCAUSLANE, BSc, MSc, PHD Research Manager
CHRISTOPHER PARKINSON, BSc, FWD* Senior Research Associate
STUARTR. WALKER,BSc, FWD, CCHEM,FRSC, CBIOL,FRCPATH,FINSTD Director Centre for Medicines Research International, Carshalton, Surrey, United Kingdom
DAVIDK. LUSCOMBE, BPHARM,FWD, FIBIoL, CBIOL,FRPHARMS hofessor, Welsh School of Pharmacy, University of Wales, Cardiff, Wales
Before reaching the market, the last stage of development through which a newpharmaceutical 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 I990 and 1995 in at least one of nine major pharmaceutical markets (Australia, Caruuia, 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, howevec 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 direrences, 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. Key Words: Regulatory review; New molecular entities; Approval times *Formerly of CMR International, now with GlaxoWellcome Research & Development, Ware, Hertfordshire, UK. Reprint address: Kate Thomas, Research Associate, Centre for Medicines Research International, Carshalton. Surrey, SM5 4DS. United Kingdom.
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K. E. Thomas, N. McAuslane, C. Parkinson, S. R. Walker, and D. K. Luscombe
INTRODUCTION
TABLE 1 Factors Which May Impact on Review Times in the Future
THE REGULATORY REVIEW of a pharmaceutical compound is the last major devel- 0 Harmonization of technical requirements opment hurdle for a new molecular entity 0 Increase in dialogue between industry and authorities (NME) before it can be marketed. This re0 New European procedures view is the final stage in a lengthy research 0 Restructuring and reorganization of authoriand development process, with total developties ment, from synthesis to launch in the
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