Another burst in Japan: drug approvals

Another burst in Japan: drug approvals

Alfred Romann 11 July 2014

Japan’s healthcare industry has been marked by a fascinating dichotomy for the last couple of decades. A dichotomy that hurt patients most of all.

On the one hand, Japan is home to the second largest pharmaceutical and biopharma market in the world. A market populated by world-class multinationals that develop leading drugs.


On the other hand, the country’s regulatory system has long been notoriously slow to approve new drugs. As a result, patients there would often have to wait years for new drugs that were already available in markets like the U.S., Canada, Australia or the E.U.

This seems to be changing.


An interesting story in Bioworld (paywall) catalogues the most recent results of regulators in Japan to speed up new drug approvals. Over the past couple of weeks, Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved six new drugs including a biosimilar and a the first new treatment for tuberculosis approved in four decades.


The faster approvals are not a coincidence but rather part of a concerted effort by the new Pharmaceuticals and Medical Device Agency (PMDA) to streamline its operations. In 2012, the PMDA approved 134 new drugs compared to just 77 in 2008, explains Catherine Makino in another Bioworld story (paywall) last month.


Japan is not the only Asian country looking to speed up drug and medical device approvals. China, which faces different challenges, is also keen to get the best and newest drugs to patients sooner rather than later. So is South Korea.

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