Abstract
“Drug lag”, absence or delay in approval of drugs that are available in other countries, has been a much debated issue. We previously reported the “drug lag” status of the US, EU, and Japan with 398 New Chemical Entities (NCEs) approved either in the three regions between 1999 and 2007. The major data such as approval date was collected from the public sources of regulatory agency of each region. In this article, the utility and limitation of public data sources are discussed.
The advantages of utilizing of public sources are that reliable, precise, and comprehensive data can be obtained cost-free. Meanwhile, the collection of the data is time and labor-consuming work and there is a limitation of data availability. However, the study suggested that the comparison of the “drug lag” status of the three regions could be done by utilizing public data and complementary commercial databases.
