Personal imports of drugs to Japan in 2005--an analysis of import certificates.

BACKGROUND

Personal imports of unapproved drugs are made by physicians and patients in Japan. Such imports require submission of a request for an import certificate from the Regional Bureau of Health and Welfare (RBHW). So far, there have been few reports on personal imports of drugs in Japan.

OBJECTIVE

To assess the extent and nature of personal imports of drugs in Japan.

METHODS

The date, product name and amount of drug imported were provided by RBHW for each personal import made by physicians in 2005. All imports were classified into several groups including whether they were for 'prescription drugs for non-cosmetic use (PDNC)' or 'prescription drugs for cosmetic use (PDC)'. Identification of PDNC was made by International Non-proprietary Name (INN). All drugs were classified under therapeutic groups. For the most frequently imported unapproved drugs, the approval year in the US/EU and development status in Japan were recorded.

RESULTS

A total of 12 196 personal imports were initiated by physicians in 2005. 5428 were for PDNCs corresponding to 242 drugs by INN. 55 PDNCs were each the subject of 10 or more imports. 11 drugs (252 imports) out of the top 55 PDNCs were available on the Japanese market during 2005 and 44 (4713 imports) were not approved. Of the 44 unapproved drugs, 11 (1019 imports) had been approved and 10 (2785 imports) were in the pre-registration phase as of December 31, 2006. Of the 44 unapproved drugs, 12 (1213 imports) were approved during 2000-2004, and 17 (3138 imports), during 1995-1999 in the US or EU. While the majority of imported drugs were antineoplastic drugs, drugs for various kinds of non-serious diseases were also imported.

CONCLUSIONS

A substantial number of unapproved drugs were being imported to Japan. A formal system for monitoring the use of those drugs should be established.