Regulatory Synergies in Device Innovation Japan – USA Regulatory Synergies in Device Innovation Bram Zuckerman, MD Director, FDA Division of Cardiovascular Devices FDA Center for Devices and Radiological Health
Disclosure Statement of Financial Interest I DO NOT have a financial interest, arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest.
Mission Statements FDA: “Protecting the public health by assuring that … medical devices intended for human use are safe and effective. Advancing the public health by helping to speed product innovations”. PMDA: “Our obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices…monitoring of their post-marketing safety…providing relief services for adverse health effects.
Japan – USA Regulatory Synergies Harmonization by Doing (HBD) What is the HBD Initiative? HBD launched in December 2003 seek regulatory convergence between FDA and MHLW-PMDA Pre and post-market review of cardiovascular device technology Utilize parallel development for application submissions and review of actual medical device projects Objective - eliminate redundancies, added costs, and time delays inherent in separate development
Advantages of Participating in HBD Time and cost for development solely in US Time and cost for development solely in Japan ≧ Time and cost for Communication (Meetings, etc.) Time & cost for “simultaneous” development in US and Japan Essential to have good planning
Harmonization by Doing (HBD) HBD is a “hands-on” approach to medical device development Involves Japanese and US stakeholders from: Government Academia Industry
HBD Structure Currently four working groups WG1: Pre-market clinical trial protocols WG2: Post-market data WG3: Clinical trial infrastructure WG4: Regulatory convergence Application of “proof of concept” (POC) principles Development steps will help identify specific obstacles and workable solutions to global development POC projects proposed to WGs by interested stakeholders
Accomplishments HBD Program is one important global strategy for improving public health in Japan and US Regulatory/scientific meetings in Japan and US since 2004 First Think Tank Meeting in Japan, 2005 Second Think Tank Meeting in US, 2007 Third Think Tank Meeting in Japan, 2008 Fourth Think Tank Meeting in US, 2009 Upcoming Fifth Think Tank Meeting in Japan, 2011
HBD is an Incubator for New Programs: PMDA-FDA Collaborative Scheme Paradigm for US and Japanese regulators to discuss device and trial information and/or regulatory submissions US and Japanese regulators work together with sponsor toward solutions Include sponsors in 3-way communications as appropriate Protect confidential and trade secret information Does not adversely affect US approval time lines
Regulatory Synergies USA and Japan Similarities > Differences Similar Missions Similar processes Similar trial design requirements Emphasize Development of Innovative Technology Total Product Lifecycle
Where Can I Find Out More? General information, announcements, and updates on HBD: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/InternationalInformation/ucm053067.htm