Regulatory Science in Japan
“Japan’s Strategy in the Era of Global Development” was the title of the presentation given at the CDISC Japan Interchange on Thursday, 12 July by Tatsuya Kondo, M.D., Ph.D., Chief Executive, Pharmaceuticals and Medical Devices Agency (PMDA). This leader of Japan’s Regulatory organization provided a very informative keynote presentation expressing appreciation of the value of standards. Many thanks to Dr. Fukushima, head of the Translational Research Informatics Institute (TRI) in Japan, for extending the invitation. After his presentation, Dr. Kondo and two of his staff met with leaders from CDISC Global Operations, TRI, CDISC Board (Dr. Lastic) and the CDISC Japan Coordinating Committee.
Dr. Kondo stated that “the purpose of Pharmaceutical Affairs is to improve the public health through regulations to secure quality, efficacy and safety of pharmaceuticals and medical devices and take necessary measures to promote R&D, where the reliability must be verified”. There are three primary roles for PMDA in their quest to improve the public health and safety of Japan: 1) to reviewing applications for marketing approval of pharmaceuticals and medical devices; 2) to conduct safety measures, and 3) to provide relief to people who have suffered from adverse drug reactions or infectious diseases.
What was very interesting was Dr. Kondo’s focus on Regulatory Science (a term which has been used prominently by FDA in recent years). He stated that Regulatory Science is a ‘Science of Estimation’, specifically “Regulatory Science estimates social impacts (benefit and risk) of scientific / technological progresses, and regulates and adjusts them for optimal social acceptance”. He continued by stating that “Regulation is a means to protect the people and keep their lives fair and safe, or a tool to build a better society…” He spoke of Scientific Integrity/Honesty and applying Academic Science to Regulatory Science to provide a contribution to the world and society. This slide shows Three Pillars of Regulatory Science that have influenced the direction of PMDA and its current structure.
In April 2009, PMDA established an Office of Regulatory Science (ORS) and a Regulatory Science Research Division in ORS. In 2011, they established the Office of Standards and Guidelines Development two-tier office with the Division of Standards for Drugs and Division of Standards for Medical Devices through which they are developing standards and guidelines by organizing the review information as well as the outcome of research on Regulatory Science.
In addition, Dr. Kondo spoke of the Society for Regulatory Science of Medical Products, which held its Inaugural Meeting on 4 October 2010. This is an organization that is made up of Regulators, Academia, Industry and Sufferers of Adverse Drug Reactions. They take no fees from Industry and have low joining rates for students and for attending lectures. They have established a joint graduate program with 12 Universities throughout Japan where PMDA employees study and which provide graduate students who work as interns at PMDA.
Dr. Kondo then presented highlights of the PMDA Strategic Plan (below).
He spoke about the presence of Japan in the global biopharmaceutical marketplace and the fact that Japan ranks 3rd in the world in developing new drugs and 2nd in the world in developing new entities.
In 2011, they have implemented new projects, including an advisory group within PMDA to provide Pharmaceutical Affairs consultation. “The consultation service was started from July 2011 in order to develop innovative drug and medical devices originated in Japan. University laboratories and venture companies with prospective seeds can receive regulatory advice on research and clinical studies from the early stage of the development.”
Another project he mentioned is the MIHARI project (Medical Information for Risk Assessment Initiative). This project leverages EHR data for safety and will make use of the CDISC IHE Integration profile Retrieve Form for Data Capture (RFD) and involves some of our CDISC advocates in Japan, Dr. Michio Kimura and Dr. Kiyoteru Takenouchi.
In 2012, PMDA has established a Science Board of external experts “in order to improve overall services from review and provide consultation on post-market safety measures. More precisely, the Board is going to pursue regulatory science, enhance cooperation and communication with academia and medical institutions, and keep pace with the advancing science and technology utilized in the products.”
He closed his talk with the following slide and then this statement: “Ultimate medical ethics is exemplified by pharmaceutical affairs; regulatory science helps to practice medical ethics.”
Dr. Kondo was very modest, interested, and generous with his time during our meeting following his presentation,. He and his staff asked excellent questions and listened intently as J3C leaders, Dr. Pierre-Yves Lastic from Europe, Wayne Kubick and Becky Kush from CDISC and Dr. Fukushima from TRI responded to the questions. J3C and TRI leaders and Dr. Lastic specifically encouraged him to use CDISC standards where applicable for the PMDA strategy and regulatory science. He seemed to appreciate the 40 minute discussion, and we certainly did. It is indeed exciting to see this support for CDISC standards coming from the highest level of PMDA.