TOKYO — Japan wants to become a regulatory leader in Asia.
A series of reforms over the past year have cut down approval times, improved the level of science regulators expect to review drug and medical device applications and helped Japanese authorities strengthen ties with their peers around the world.
"In terms of philosophy, fundamentally, regulatory science is what we value the most. Based on the regulatory science, we make regulatory innovations and keep reforming ourselves on how to regulate drugs and medical devices," Tatsuya Kondo, chief executive of the Pharmaceuticals and Medical Device Agency (PMDA) of Japan, told Medical Device Daily in an exclusive interview.
Reforms are having an impact
The reforms are making a difference. Not only is the agency speeding up drug approvals, it is also providing benefits for patients that suffer adverse effect from drugs and working with international stakeholders on harmonization issues. The result has been an influx of investment in the country's biotech and med-tech sectors.
A key area of focus for Japan is international regulatory harmonization.
Japan is one of the founding countries of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The ICH brings together regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of drug registration.
"We understand every country's regulatory authority have to have worldwide thinking," said Kondo. "So our agency decided to perform in programs like ICH to cover the entire world."
The PMDA's associate executive director for International Programs, Toshiyoshi Tominaga, said the ICH is now undergoing a major transformation.
"There will be a new entity within this year, hopefully this month or so," Tominaga told MDD.
The U.S., EU, Japan and two new members from Canada and Switzerland are the key participants in the ICH. Representatives from EU, European Federation of Pharmaceutical Industries and Associations (EFPIA), Japan Ministry of Health, Labor and Welfare (MHLW), Japan Pharmaceutical Manufacturers Association (JPMA), U.S. FDA, Pharmaceutical Research and Manufacturers of America (PhRMA), Swissmedic and Health Canada sit on the steering committee that oversees harmonization and have voting rights. WHO is an observer on the steering committee and the IFPMA participates as a non-voting member.
"The reform progress is slower than we expected," said Tominaga. "But under the new regime, we'll retain the leading position so we can contribute to ICH more properly."
As a major health authority in Asia, Japan's PMDA also faces the issue of how to select appropriate Western products that also meet the needs of Asian consumers. For example, the China Food and Drug Administration (CFDA) requests additional clinical data from trials involving Chinese people to prove safety and efficacy of western-developed drugs.
"From the technical side, recently multi-regional clinical development is very common," said Junko Sato, director of the PMDA's Office of International Cooperation. "In the past, drug development was lagging behind in Japan compared with the U.S. and EU. Now it's parallel," Sato told MDD.
"If we can identify the reasons for different drug dosages and therapies needed for different people and ethnicities, we encourage regulatory science to identify the root causes," said Sato.
"There is a lot of academic science research going on . . . also a lot of 'mad science' . . . when products are introduced to the society, the safety, efficacy and quality of the products must be controlled by the agency through regulatory science," said Kondo.
International harmonization of regulatory requirements and better science are not enough to make sure medical products in Japan meet the needs of patients. A key metric is approval times.
Between 2004 and 2013, Japan and Canada showed the most notable improvement in average approval times for applications among the six most important regulatory authorities in the world, according to data from the FDA. The PMDA's median approval time for new active substances dropped from 600 days in 2004 to 300 days in 2012. Now Japan is on the same level with the FDA and is faster than the EMA.
"There's a pressure from the industry of course, but drug lag and device lag is detrimental to public health," said Tominaga.
The PMDA is not looking to speed up the research and development process for new products by providing consultation to industry.
"We shortened approval times but there's still lag in development from industry," said Tominaga. "We're trying to compress that development time of the industry because we have caught up with the U.S. in regulatory approval time."
Japan has long been a leader in regenerative products. It takes about two to three years to get a regenerative product to market here, which makes it four or five years faster than Western countries.
Companies from other Asian countries have expressed their willingness to work with Japan in this area. On Sept. 3, two more regenerative drugs were approved in Japan.
Global regenerative medicine leader, Mesoblast (Melbourne, Australia), also reported that day that the allogeneic mesenchymal stem cell-based regenerative medicine JR-031, developed by its Japanese partner JCR Pharmaceuticals, had been recommended for approval, and a marketing approval is expected in the near future.
"The PMDA is advanced with the relief system and regulatory innovation in regenerative medicine, so it's easier to develop [regenerative] products in Japan," said Tominaga, "That's why other countries' are having joint venture with Japanese companies."
In 2004, the PMDA started a one-of-a-kind Relief Service for Infections Acquired Through Biological Products system to provide benefits to people suffering from adverse health effects with a biological origin, such as infections, acquired through drugs or medical devices. Certain cancer and immunosuppressant drugs are not eligible for relief benefits, but regenerative drugs are. //