Japan’s PMDA To Roll Out New Safety Infrastructure And Drug Development Support

After successfully reducing Japan’s drug and device approval lag, PMDA Chief Executive Tatsuya Kondo is ready to support drug development with an emphasis on regulatory science.

TOKYO – Tatsuya Kondo, the chief executive of Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), believes it’s his agency’s duty to offer a supporting role in the development of new drug and device technologies. Now that the agency has decreased the much-maligned approval lag, PMDA will likely take a more active role in promoting academic and startup drug development as well as improving product safety infrastructure.

Kondo, speaking during a Sept. 12 event hosted by the health care committee of the American Chamber of Commerce in Japan, said PMDA “had various issues when I joined as chief executive five years ago.”

At the time, drug and device approval lags were viewed as a barrier to entry in Japan. Kondo also felt it necessary to enhance safety measures. He determined it necessary to reform PMDA by promoting regulatory science and strengthening global partnerships with other countries to become a more capable agency.

In 2010, PMDA rolled out a plan to apply regulatory science as the basis of the agency’s activities. Within PMDA, regulatory science is now viewed as supporting the agency on three pillars: microscopic regulatory science used to improve PMDA’s evaluation methods for quality efficacy and safety; macroscopic regulatory science used to assess the risk-benefit and cost-benefit profiles of new products, and regulatory science engineering to facilitate translational research at universities and research institutes.

By 2012, the approval time for PMDA’s standard review of new drugs dropped to 10.3 months, down from 22 months in 2008. The standard review of new medical devices dropped to 12.7 months from 28.8 months in the same period (Also see "Approval Agency Reforms In Asia Leave Mark On Drug Pricing – DIA Asia New Drug Development Conference" - Scrip, 30 Apr, 2013.).

On Par With U.S. FDA

Perhaps of more interest for PMDA, which wants to be on par with U.S. and EU regulators, it now claims it has surpassed EU and U.S. FDA’s Center for Drug Evaluation and Research in NDA reviews.

Now, PMDA is in the process of improving its safety oversight of medical products. The agency is currently developing infrastructure to collect health data from 10 million patients in Japan by building database hubs at 10 university hospitals. The data, which Kondo said will be used for post-market safety studies and other risk assessment measures, will be available for use by 2015.

PMDA has also increased the number of reviewers by 70 in the past five years, but it’s still fewer than 100 people, according to Kondo, who said the goal is to reach 105 drug and device reviewers.

Kondo told ACCJ that now that the drug and device approval lags have been reduced successfully, he and PMDA will turn to helping improve Japan’s capabilities for new drug and medical device development.

PMDA launched a program for pharmaceutical consultations on R&D strategy in July 2011 to provide guidance to academia and venture firms on what is needed to bring research seeds to market.

Confidential Meetings

Since 2012, PMDA has held Science Board meetings closed to the public to allow discussion of confidential data. Comprised of researchers from universities and medical institutions, the board changes membership every two years, which allows PMDA to strengthen its relationship with academia.

Similarly, included in MHLW’s 2012 budget was a program to introduce regulatory science-based evaluation methodologies at universities “involved in the research of the most advanced technologies,” Kondo said. As of May, 21 research institutes in Japan are participating in the program.

In recent meetings, the science board has discussed how to organize biomarkers and endpoints in clinical evaluation, as well as the requirements for non-clinical pharmacology studies for cancer drugs. The science board’s special committee on medical devices recently discussed establishing a policy for the development of combination products, as well as the regulatory scope of review for generic medical devices, according to Kondo

Japan Prime Minister Shinzo Abe has made health care services a part of his cabinet’s June 2013 economic revitalization strategy. As part of the strategy, PMDA is expected to be involved in the creation of a Japanese version of the U.S. National Institutes of Health, which will act as “a control tower” to “bridge between research and clinical practice.”

[Editor’s note: This story was contributed by PharmAsia News , which provides daily coverage of the Asia biopharmaceutical industry and regulatory policies. To learn more, sign up for a free trial – no credit card needed.]