Abstract
Objective: “Local drugs” (or “country drugs”) are medicines which are approved and distributed only in
Japan. “Drug lag” and “drug loss” indicates medicines approved in other countries (the US or Europe) which
receive delayed or no approval in Japan, respectively. Specifically, the former problem indicates the “overdevelopment”
of medicines, while the latter indicates “under-development.” Notably, drug lag remains a
controversial issue in Japan from 2000s. This study quantitively clarifies the current situations of these
problems in Japan.
Methods: For local drugs, I used the list of medicines approved by Japan’s Pharmaceuticals and Medical
Devices Agency (PMDA) from 2017 to 2023. These data were combined with the approval status of the US Food
and Drug Administration (FDA) and European Medicines Agency (EMA). Next, the new medical entities (NMEs)
approved by the FDA from 2017 to 2023 were examined to quantify the problems of drug lag and drug loss in
Japan. Besides Japan, the launch days of the following countries were obtained from the Multinational Integrated
Data Analysis System (MIDAS) database by IQVIA: Europe (Germany), the UK, Switzerland, Canada, Australia,
New Zealand, Korea, Taiwan, and Singapore. These days were compared with the approval days by the FDA.
Results: For new medicines without new ingredients, the percentage of local drugs in Japan is approximately
40%. This number reaches 60% if the manufacturers are limited to Japanese companies. The main developers of
local drugs are relatively small-size Japanese companies. Next, 20% of the new medicines with new ingredients
were not approved either by the FDA or EMA. This number rises to 40% of medicines which were manufactured
by Japanese companies. Meanwhile, the percentage was even higher for regenerative medical products.
Further, 70% (80% for Japanese companies) of the medicines approved first in Japan were not approved by
the FDA or EMA. Conversely, regarding the drug lag and drug loss, the proportion of the launched medicines
in Japan to the FDA-approved medicines was inferior to Europe (Germany) and the UK. However, it was the
comparable with Canada and Switzerland, and higher than that in both the Oceanian (Australia and New
Zealand) and Asian countries (Korea, Taiwan, and Singapore). The results remain unchanged during the subgroup
analysis for anti-cancer drugs, orphan drugs, and drugs developed by new companies. Finally, the time
to launch in Japan from the FDA approval day is similar to that in Canada and Switzerland. It is much faster
than the three Asian countries. This is especially true for the launch speed of anti-cancer drugs, where it is the
highest except that in Germany and the UK. However, the launch speed of orphan drugs tends to be lower.
Discussion: Clearly, the problem and percentage of local drugs are not negligible. In terms of drug lag and
drug loss, most medicines are available in Japan except that in Germany and the UK. As Germany is one of the
best countries among European countries in terms of the access to new medicines, the Japanese situation may
be better than several European countries. Considering these results, further investigation is needed regarding
how much investments should be made to improve access to medicines. Finally, the policy’s cost-effectiveness
about drug lag or drug loss should be discussed.
