The evaluation of new drug introduction in nine developed countries, 1970-1983

Wenchen Kenneth Wu, Albert I. Wertheimer, Ronald Hadsall

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This study evaluated the factors affecting drug lag in nine developed countries during the period of 1970-1983. Drug lag is defined as the chronological difference of a drug approved in a study country and the corresponding drug in the first approval country. 723 New Chemical Entities (NCEs) that were approved in at least one of the study countries were included in the study. Cox's proportional hazards model was used to estimate the effect of safety/efficacy control, price control, and market attractiveness on drug lag. The results indicated that less stringent safety/efficacy control, greater price control, and larger market size were associated with shorter drug lag. However, an analysis of a subgroup of five countries, which controlled the variation of the degree of safety/efficacy control, revealed that favorable price control was associated with shorter drug lag. We concluded that price control would take a more prominent role in the future new drug introduction decision.

Original languageEnglish (US)
Pages (from-to)296-308
Number of pages13
JournalJournal of Social and Administrative Pharmacy
Issue number4
StatePublished - Dec 1 1998


  • Drug lag
  • Drug legislation
  • Industry, pharmaceutical
  • International
  • Market size
  • Models, theoretical
  • NCEs
  • Price control
  • Safety and efficacy control
  • Survival analysis


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