Since taking the role of chief executive of the Pharmaceuticals and Medical Devices Agency (PMDA) in 2008, Dr. Tatsuya Kondo has transformed how medical products are approved in Japan.
Through improved methodology, with an emphasis on regulatory science as an industry framework over the last ten years, the PDMA has been able to accelerate Japan’s drug approval process, making it amongst the world’s fastest. In fact, Dr. Kondo’s model of regulatory science has been popularized around the globe.
It is for these reasons that we are so honored that Dr. Kondo will be the keynote speaker at the BIO Asia International Conference March 5 - 6, 2019 in Tokyo.
The timing of Dr. Kondo’s talk is all the more pertinent, given the recent policy changes in Japan that can have an impact on its innovation environment, as well as the Trump Administration’s desire to negotiate a trade agreement which includes biopharmaceuticals and medical devices with Japan. In particular, Trump has signaled a desire for Japan to adopt standards that would improve IP and market access for U.S. products.
U.S. Trade Representative Robert Lighthizer announced this week during congressional testimony that initial trade talks with Japan will likely launch as early as next month.