1. 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

2. 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.

3. Medical Device RegulationsEU
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

4. Lessons learned
Building trust is the key to “harmonization”

5. 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

6. 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 ….”

7. 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!

8. Building Trust through HBD

9. 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

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

11. 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

12. Thank you! Madoka Murakami, Ph D Murakami-Madoka@pmda.go.jp