Lessons Learned Through HBD: The Regulator’s View - PMDA Perspective Madoka Murakami Unit Chief Office of International Programs Pharmaceuticals and Medical Devices Agency (PMDA), Japan

  I, Madoka Murakami, 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 in the context of the subject of this presentation.

Medical Device Regulations EU Japan US Third Party Certification (requirements depend on device classification) Class III, IV: Minister’s approval with PMDA’s review Class II, some of Class III: Third Party Certification Class I: Self-declaration Class III: PMA Approval Class II: 510(k) clearance, Class I: exemption FDAは第三者認証ないことはないが、ほとんど使われていない。 Governmental approval/license Notified body review/certification Self declaration

Lessons learned Building trust is the key to “harmonization”

Device lag 15 years ago in Japan… Not so many medical device clinical trials were conducted in Japan Requirement of Ministerial notification: “2 clinical institutions, 60 cases” for medical device clinical trials (This notification is no longer available) Small number of reviewers No close communication with US FDA Device lag

Barriers in the past Actual barriers: Elusive barriers: Lack of regulatory information, Difference between regulations, Lack of experience, lack of communication Elusive barriers: “it seems difficult” “it seems unreliable” “It seems ….”

Building Trust through HBD POCｓ Actual barriers: Lack of regulatory information, Difference between regulations, Lack of experience, lack of communication Elusive barriers: “it seems difficult” “it seems unreliable” “It seems ….” GCP comparison STED comparison Harmonized data elements for post market registry Regular communication Unexisting barriers!

Building Trust through HBD

Many kinds of HBD Harmonization by Doing: HBD Harmonization by Developing guidelines and standards: IMDRF, ICH, ISO/IEC… Harmonization by Discussions: ICMRA, ICDRA, APEC RHSC

Specificity to/from Generality Bi-lateral to/from Multi-lateral ニッチ 革新的な

Collaboration Among Stakeholders Industry Academia Patient This slide shows the group of shareholders surrounding the medical society, that are, Academia, Industry and regulatory agencies. これらは医療を取り巻く重要なstakeholderのグループ、すなわち科学界、産業界、他国も含めた規制当局です。 Regulatory Authorities

Thank you! Madoka Murakami, Ph D Murakami-Madoka@pmda.go.jp https://www.pmda.go.jp/english/index.html