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March 02, 2013

Japan altering regulations to approve practical regenerative medicine in 5 to 7 years instead of 10 years

The government will likely create a system to approve regenerative medicine products earlier than before as part of efforts to promote practical use of induced pluripotent stem cells and other such treatments.

The Health, Labor and Welfare Ministry as been proceeding with a plan to create the system by granting production approval at an earlier stage, a key pillar of the plan.

The government has so far approved only two regenerative medicine products--one for the reproduction of new skin to repair severe burns and another for the regeneration of knee cartilage.

The government's screening process, which usually takes about 10 years, is set to become a major bottleneck and hinder the progress of a large number of regenerative medicine products.

Under the new system, the government plans to grant approval with some conditions after confirming the safety and estimating the effectiveness of the products.

After the products are put on the market, the government will verify their effectiveness and grant official approval.

The introduction of the new system is expected to shorten the time needed to secure government approval by three to five years and help lessen the burden on companies--which should accelerate the commercialization of the products.

Japan's government also promises to back regenerative medicine and stem cell ventures with 110 billion yen ($1.17 billion) of hard cash.



Under another pillar of the plan, the government will oblige medical institutions to report their clinical studies and treatments using iPS cells, among others.

By creating a system to ascertain the actual conditions of clinical practice, the government plans to promote safe and secure regenerative medicine.

The ministry plans to submit to the current Diet session two bills related to governmental approval and firms' reporting of data.

Meanwhile, the government should establish a system to foster the donation of third-party cells so that many patients can benefit from regenerative medicine.

In regenerative therapies, generally a patient's own cells are used to generate the cells used for transplants on the patient's body.

Shinya Yamanaka is an oddity. The 50-year-old scientist shared the 2012 Nobel prize for medicine for his work reprogramming mature cells into induced pluripotent stem (iPS) cells

Dr Yamanaka’s success comes just as Japan is reaping the benefits of a transformation in the way it approves, pays for and administers drugs. The aim is to spur innovation and curb rising age-related health costs. The world’s biggest drugmakers are licking their lips.

“For foreign [drug] companies, it’s [Japan] the best market in the world right now,” says Ira Wolf, Japan representative of the Pharmaceutical Research and Manufacturers of America, a lobby group. Sales growth for the top eight multinational drug firms in Japan in 2011 ranged from 12% to 31%, he says, which he calls “emerging-market” growth rates. The firms are now shipping some of their brightest researchers to Japan.

Deregulation has come in three areas. First, the government has speeded up its review of new drugs, eroding Japan’s so-called “drug lag” against approval processes in America and Europe. The vastly expanded Pharmaceuticals and Medical Devices Agency (PMDA), which conducts the approval process on behalf of the Health Ministry, has slashed review times since 2008 and increased the number of new drugs it has approved (see chart). Last year it created a Science Board of outside experts to improve its rulings on cutting-edge technologies such as Dr Yamanaka’s tissue engineering. “This is a matter of survival for Japanese industry,” says the PMDA’s Takao Yamori.

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