Collaboration/cooperation with external institutions Partnership with PMDA

AMED concluded a partnership agreement with the Pharmaceuticals and Medical Devices Agency (PMDA) on August 19, 2015.

AMED and PMDA mutually utilize the knowledge and experience for the creation of innovative drugs, medical devices, and cellular and tissue-based products originating from Japan. Each agency fulfills its mission and responsibilities through the following operations: promoting “R&D" in the medical field conducted by AMED and reviews and consultations conducted by PMDA.

• For clarification, the following special clause was inserted into the contracts of the R&D projects entrusted from April, 2016, onward: “In principle, projects transitioning to a practical stage among those selected by AMED receive Pharmaceutical Affairs Consultation on R&D Strategy by PMDA.
• As necessary, AMED officials participate as observers in Pharmaceutical Affairs Consultation on R&D Strategy processes regarding the research projects and use the opportunity to measure the progress of project management.
• AMED and PMDA have set up contact points at each end and share information regarding Pharmaceutical Affairs Consultation on R&D Strategy.

• PMDA dispatches its officials as lecturers to various training programs (advanced CRC, data manager training, etc.) organized by AMED.
• The Department of Clinical Research and Trials in AMED and the Office of Safety in PMDA exchange opinions and share information regarding the implementation environment (GCP compliant) of the investigator-initiated trials.

• Toward the development of the Clinical Innovation Network (CIN), the research groups selected by AMED cooperate with “PMDA's WG."
• President of AMED, Makoto Suematsu, MD, PhD, explained the issues and other matters in the drug discovery process originating from academia at the Science Board of PMDA.
• AMED and PMDA hold joint workshops.
• AMDA notifies researchers of the information published by PMDA, when appropriate.

*GCP：Good Clinical Practice

• AMED and PMDA regularly hold opinion exchange meetings.
  • AMED and PMDA hold opinion exchange meetings where presidents and all the executives of both sides attend.
  • At these meetings, both sides report on organizational efforts, discuss about projects and future directions, and share their awareness when promoting “R&D" in drugs and medical devices, etc. in academia.
• PMDA officials cooperate as scientific technology inspectors in AMED's Practical Research Project for Rare / Intractable Diseases Research Program.