TOKYO – Japan is taking further steps to speed up reviews of innovative new drug and medical device applications through a new Sakigake designation. Sakigake roughly translates into "leading the way."

Japan has been working to speed up reviews and approvals for more than a year as part of an effort to lead the world in innovative medical products.

The aim of this and other efforts is to promote research and development while attracting more pharmaceutical products, medical devices and regenerative medicines to the market as quickly as possible, according to a the Ministry of Health, Labour and Welfare (MHLW).

"The Sakigake designation is similar to the U.S. breakthrough designation aiming to speed up the approval of extremely innovative drugs," Toshio Miyata, executive director of Japan's Health and Global Policy Institute, told BioWorld Today. "For example, anti-PD-1 antibody drugs are within this category." The Sakigake designation will not cover biosimilars, said Miyata, even though the number of biosimilar approvals in Japan is on the increase thanks to a government push to promote them.

The MHLW's Pharmaceutical Affairs and Food Sanitation Council announced the latest push for quicker reviews during the first week of April. The reviews will be launched this year as the regulator continues to focus on shortening review times on products that display novel mechanisms of action, are commercially scalable, have high efficacy and are launched in Japan first.

The Sakigake designation covers basic research spanning clinical research, approval reviews and safety measures to insurance coverage and improvements in infrastructure or environment for company activities and global expansion.

"The Sakigake designation system encourages any company, irrespective of nationality, to develop drugs first in Japan," says Reed Maurer, a veteran Japanese pharmaceutical industry watcher and president of International Alliances.

The designation will include prior reviews by the Pharmaceuticals and Medical Devices Agency before the launch of phase III studies. A key component is cutting in half the time between phase III document submissions and clinical trial consultations from two months to one month, while the review period will be cut from a year to six months.

Reemerging as a global driver of biotech innovation is a key goal for Japan.

During the later half of the 1980s, the country led the world in terms of first launches of new or improved drugs. Over the decades that followed, and for a variety of reasons, the pendulum swung and Japan become one of the slowest countries in the world by that measure. Despite being one of the largest pharma and biotech markets in the world, Japanese patients often have to wait months or years before having access to the latest innovative drugs.

"[Japan] was then criticized for a drug lag by many stakeholders, including patient groups," Maurer explained. "Sakigake is a response to this criticism. Also, Japan lags in providing a fertile regulatory ground for the development of so called orphan drugs indicated for rare diseases."

In other words, the regulatory pathway for a drug to treat relatively common ailments such as hypertension, for example, is quite different than that for a drug to treat a few patients. Often times, orphan drugs originate in academic labs that require more guidance in terms of drug development.

Sakigake aims to speed that process of innovation.

"In short, the motives for Sakigake are not to help commercial companies expand globally, but rather to get new drugs to Japanese patients faster," Maurer said.

The MHLW made that intention clear. It said speeding up the availability of drugs that treat serious, if often rare, diseases is in everybody's interest, particularly when the drugs are the first available treatments or have significant advantages over existing treatments.

The second part of the Sakigake strategy calls for rapid authorization of drugs aimed at speeding up the path to market of unapproved or off-label use of drugs for serious and life-threatening diseases by expanding the scope of the Council on Unapproved Drugs and Off-label Use to include unapproved in Western countries.

Under the new rules, drugs that satisfy certain conditions and improve the environment for companies to undertake development of such drugs may be processed faster.

The MHLW will implement those policies during the budgetary request process in 2015, but some of them, which are ready, will be executed ahead of schedule.