PMDA established PMDA Washington D.C. Office as its first U.S. base
Objectives of establishment of PMDA Washington D.C. Office
PMDA Washington D.C. Office has been established in Washington, D.C. as the first PMDA’s U.S. office, dated November 1, 2024. This is our second overseas office after the Asia office that we established in Thailand in July.
As more and more innovative drugs are being developed by overseas start-ups (especially in the U.S.), such drugs are needed to be developed rapidly also in Japan. To work on the issue, the PMDA decided to establish the office in Washington, D.C.
Ref. Establishment of PMDA Washington, D.C. Office - as First U.S. Base - (News Release) [434KB]
Services of PMDA Washington D.C. Office
In the office, we will promote enhancement of regulatory cooperation and information exchange on regulations with administrative organizations in the U.S., including the U.S. Food and Drug Administration (FDA) on site. And for start-ups which locate in the U.S., we will provide the information regarding Japanese regulations on reviews and post-marketing safety measures, as well as offer the services including early general development consultation and related services. We believe that these measures will support to promote the development of innovative drugs and medical devices in Japan, contributing to making everyone’s lives brighter together.
Message from the Head of the PMDA Washington D.C. Office
I’m Akihiro Ishiguro, Head of PMDA Washington D.C. Office. My work at PMDA began in 2004 when PMDA was established, allowing me to involve in post marketing drug safety, new drug review, review management, and regulatory science research promotion. In order to contribute to the development of regulatory standards in the fields of Pharmacokinetics and Clinical Pharmacology, I have also involved in number of projects to develop regulatory guidelines, including international harmonized guidelines at ICH (Note 1).
Since 2017, I have served as a Pharmacokinetic review leader in the Center for Product Evaluation, PMDA, and have experiences as a primary investigator for the AMED research project (Note 2) and a regulatory chair of the ICH M12 Expert Working Group (Guideline on Drug Interaction Studies). In the office, I will utilize my experiences to strengthen cooperation with administrative organizations in the U.S. such as the U.S. FDA. I will also contribute to disseminate information about the characteristics of Japanese regulations so that start-ups which locate in the U.S. can become more interested in developing products in Japan.
(Note 1) International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
(Note 2) Japan Agency for Medical Research and Development (AMED), Research on Regulatory Science of Pharmaceuticals and Medical Devices: Achievements - Development of guideline on Population Pharmacokinetic and Pharmacodynamic Analysis -
Head, Pharmaceuticals and Medical Devices Agency (PMDA) Washington D.C. Office
Akihiro Ishiguro, Ph.D.
November 2024
Access
1730 Rhode Island Avenue, NW, Suite 403, Washington, D.C. 20036, USA
Near stations: Washington Metrorail, Red Line: Farragut North St. or Dupont Circle St.