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"Drug lag" persists in Japan

Drug lag persists in Japan - medical translationWhile being an economic powerhouse in many industries, Japan struggles in the medical device and pharmaceutical sectors. The country's market has long been hampered by regulatory roadblocks and stagnant, uncompetitive domestic producers.

But what a difference a year makes - if you are a medical device manufacturer, that is. Pharmaceutical and biotech companies are still very much experiencing (and frustrated by) the Japanese new drug lag.

The Japanese drug lag emerged in the late 1980s and worsened throughout the 1990s. A combination of regulatory, healthcare policy, political, and economic challenges caused new drug approvals in Japan to take about 30 months longer than in the U.S.:



Japan has taken a two-pronged approach to speeding-up drug approvals, as described by pharmalicensing.com:

The first major change took place by conducting the revision of GCP, for safety concerns of clinical trials and to set up an internationally harmonized guideline. It also recognized foreign clinical trials to help minimize expensive duplication of effort. While this was taking effect and getting settled, the second development occurred in 2001-2002, with the revision in the Pharmaceutical Affairs Law. This law stipulated on the regulations relating the efficiency, quality and safety. Setting up of the Pharmaceutical and Medical Device Association is also a major step taken toward /improving and reducing the drug lag.
Have these efforts made a difference? It's still too early to tell.

A couple of years ago, just as the situation got even worse and some pharma companies were pulling out of Japan, industry began to see some improvements. And a few months ago, PhRMA politely applauded the innovations and progress being made in Japan - but is also pushing for further, faster change:
"PhRMA appreciates the ongoing efforts on the part of the U.S. Government and the Government of Japan and hope that any future reforms will continue to move in this direction."
Hopeful signs all around - but for now the Japanese new drug lag is still very much a reality.


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