PMDA Update: pIts current situation and future directionand future direction
Tatsuya Kondo, M.D. Ph.D.Tatsuya Kondo, M.D. Ph.D.Chief Executive
Pharmaceuticals and Medical25th Annual
Pharmaceuticals and Medical Devices Agency (PMDA), Japan EuroMeeting
4-6 March 2013RAI, Amsterdam
Netherlands
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Contents
PMDA Update;PMDA Update;
Its current situation and future direction
1. Organization
2 A ti iti i M di i l P d t2. Activities in Medicinal Products
3. Activities in Medical Devices
4. International Activities
3
PMDA’s Safety Triangle
Unique Three-pillar System Securing Nation’s Safety
ReviewReduction in
Risk
Japanese CitizensJapanese Citizens
Safety ReliefR li f Safety
Continuous risk mitigation
efforts
Relief measures for health
damage caused by risk factors
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efforts by risk factors
PMDA Staff Size
800
Ad i i t ti t751751
600
700Administrative part
Safety Department
ReviewDepartment
648648605605
678678
500
600 Review Department
Planned521521
426426
300
400 341341319319291291256256
200
256256
0
100
5
2004 2005 2006 2007 2008 2009 2010 2011 2012 2013
Major Changes
Special Assistant for Chief Executive (Feb. 2012)Special Assistant for Chief Executive (Feb. 2012)
Office of Review Innovation (Apr. 2012)Office of Review Innovation (Apr. 2012)
Science Board (May 2012)Science Board (May 2012)
Director of Center for Product Evaluation appointed (June 2012)Director of Center for Product Evaluation appointed (June 2012)
Placed 2 Deputy Center Directors (June 2012)Placed 2 Deputy Center Directors (June 2012)
Reorganization of Office of Biologics (October 2012) Reorganization of Office of Biologics (October 2012)
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Organization Chart of PMDA
Office of Relief Funds
Offices of General Affairs / Office of Financial Management / Office of Planning and Coordination
Auditor
Auditor
Chief Relief Officer
Executive Director
Chi f R li f Offi
Chief Management Officer
Office of Review Administration
Office of Regulatory Science
Office of Standards and Guidelines Development
Associate Center
Director
Associate
AuditOffice
Chief Relief Officer
Office of Review Administration
Office of Review Management
Office of International Programs / International Liaison OfficersExecutive
Directorf C t
Associate Center
Executive Director
Chief
Office of Vaccines and Blood Products
Office of New Drug Ⅰ - ⅤExecutive Director
of Center for Product Evaluation Associate
Center Director
Center Director
Chief Executive
Office of Cellular and Tissue-based Products
Deputy Center Office of Vaccines and Blood Products
Office of Medical Devices Ⅰ-Ⅲ
Office of OTC/Generic Drugs
Associate Executive
DirectorDeputy Center Director
(for Cellular and Tissue-based
Products)
Office of Conformity Audit
Office of GMP/QMS Inspection Senior
Director
Principal Senior Scientist / Senior Scientists
Deputy Center Director
(for Medical Devices)
Office of Safety Ⅰ, Ⅱ
Office of GMP/QMS Inspection Executive Director
Chief Safety Officer
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Contents
PMDA Update;PMDA Update;
Its current situation and future direction
1. Organization
2 A ti iti i M di i l d t2. Activities in Medicinal products
3. Activities in Medical devices
4. International Activities
8
Review Time for New Drugs
Priority Review Products
FY 2008 FY 2009 FY 2010 FY 2011 FY 2012(As of Oct)
FY2012Target
15 4 11 9 9 2 6 5 6 1 9T t l R i Ti (M th) 15.4 11.9 9.2 6.5 6.1 9
Regulatory Review Time 7.3 3.6 4.9 4.2 3.9 6
Applicant's time 6 8 6 4 3 4 2 0 1 1 3
Total Review Time (Month)
Applicant s time 6.8 6.4 3.4 2.0 1.1 3
Standard Review Products
FY 2008 FY 2009 FY 2010 FY 2011 FY 2012(As of Oct)
FY 2012Target
22.0 19.2 14.7 11.5 10.0 12
Regulatory Review Time 11.3 10.5 7.6 6.3 6.0 9
Applicant's time 7 4 6 7 6 4 5 1 3 9 3
Total Review Time (Month)
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Applicant s time 7.4 6.7 6.4 5.1 3.9 3
Pharmaceutical Affairs Consultation on R&D Strategygy
Valley of Death -Short of funds, Knowledge on Regulation and development strategy, g g p gy
Strategic Consultation
Practical Use
Basic Research
Pharmaceutical and
Strategic Consultation
Innovative Products originated from Japan
Pharmaceutical and Medical Devices
candidatesNon-
Clinical Study
Quality Study
Clinical Trial
Up to the levelf POC diStudy of POC studies
* Further studies are handled by the Regular
Consultation on quality or toxicity study of biologics,
Consultation on endpoints or sample size
Consultation
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y y gcell-and tissue-based products
p pof early clinical trial
Science Board
Science Board
Committee
・Committee members: External experts from Academia・Not involved in the Review Process of individual products
Recommendation on1. Review policy for innovative medical products2 Development of guidelines
Committee
2. Development of guidelines 3. Regulatory Science Research4. Personnel exchanges between PMDA and Academia5. Election of External review experts6 Improvements in the scientific aspects of review6. Improvements in the scientific aspects of review
Subcommittee
Deliberation on problems in each fieldCollaboration with PMDA working team (RS research, guideline development, etc.)
Cell- & tissue- Based products
Medical Devices
Pharma-ceuticals
Bio-basedproducts
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productsDevicesceuticals products
Promotion of personnel exchange
human resource developmentdevelopment
ReviewersNIHS
Universities and research institutions
Medical Institutions
Researchers
Outcome of researches Fostering of Regulatory
Scientist↓
Acquisition of innovative technologies
Speed up and improve
D l t d d d id li t l
Promotion of appropriate R & D
Speed up and improve product review
Develop standards and guidelines at early phase
Facilitate practical application of innovative technologiesg
Decrease drug /device lag
Improving Safety Measures
AnalysisCollection of Collection of InformationInformation
New Risk
InformationInformation
management system HypothesisHypothesisAssessment of
Safety measure ff t
Planning and Implementation of
Evaluation of Evaluation of hypothesishypothesis
effects
Safety measures
Crisis managementCrisis management
• Prevention of serious drug safety-related crisis from Japan
• Effective encouragement of proper drug use.
GoalGoal
• Ensuring credibility to post-market safety management system.
Contents
PMDA Update;PMDA Update;
Its current situation and future direction
1. Organization
2 A ti iti i M di i l d t2. Activities in Medicinal products
3. Activities in Medical devices
4. International Activities
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Medical Device
Procedure
M t i lMaterial
FIndication
Formtreatment
diagnostic
Medical Devices Regulation
EU Japan US Brazil Canada Singapore
Pre-market review
Notified bod
Class III, IV: Minister’s approval
Class III: PMAApproval Class III, IV:
Registro to ANVISA
Class II, III, IV: License from Health Canada
Class B, C, D: Registration to HAS
Notified body certification (requirements depend on device
Class II: Notified body certification
Class II: 510(k) clearance,
ANVISA
device classification)
Class I: Self-declaration
Class I: exemption
Class I, II: Cadastro to ANVISA Class I:
exemptionClass A:
exemption exemption exemption
Notified body review/certification Self declarationGovernmental approval/license
Harmonization By Doing (HBD)
• Activity between Japan and USA to develop global clinical trials and address regulatory barriers that may be impedimentstrials and address regulatory barriers that may be impediments to timely device approvals. (since 2003)
SteeringCommittee
FDA MHLW/PMDA DCRI JAG AdvaMed JFMDA
Report, RequestGuidance/Suggestion
Working
WG1:Global Cardiovascular Device TrialsWG2: Study on Post‐market RegistryWG3:Clinical Trials Infrastructure and Methodology
h k k ( l k )
GroupsWG3:Clinical Trials Infrastructure and MethodologyWG4: Regulatory Convergence and Communication
•HBD Think Tank East 2013 (July 8‐10, Tokyo, Japan)
J-MACS
Future partnership between Japan and the US
(US Registry: INTERMACS)
Contents
PMDA Update;PMDA Update;
Its current situation and future direction
1. Organization
2 A ti iti i M di i l d t2. Activities in Medicinal products
3. Activities in Medical devices
4. International Activities
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PMDA’s international activities
【PMDA International Vision: PMDA EPOCH】
1.Highest level of Excellence in Performance
2.Close Partnership with the Orient
3 Contribution to International Harmonization
Strengthen bilateral and multilateral relationship
3.Contribution to International Harmonization
Strengthen bilateral and multilateral relationship
Enhance human resource exchange / Cultivate employees with international minded and communication skills
Improve International PR activities / information transmission
Dissemination of Information
Review ReportReview ReportReview ReportReview Report
Safety InformationSafety InformationSafety InformationSafety Information
PMDA U d tPMDA U d tPMDA UpdatesPMDA Updates
News ReleaseNews Release
And more…And more…
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The First Indonesia-Japan Symposium
Date: February 13, 2013Venue: Jakarta IndonesiaVenue: Jakarta, IndonesiaFocus on: Pharmacovigilance and Good Distribution Practice
Organizers: Pharmaceuticals and Medical Devices Agency (PMDA)
Japan Pharmaceutical Manufacturers Association (JPMA)
National Agency of Drug and Food Control (NADFC)National Agency of Drug and Food Control (NADFC)
Gabungan Perusahaan Farmasi Indonesia (GPFI)
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3rd PMDA Training Seminar
2013 January 21-25
Post-Marketing Safety & Relief Servicesg y18 trainees from 6 countries: Korea, Taiwan,
Indonesia, Singapore, Brazil, Ukraine
Website: http://www pmda go jp/english/events/
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http://www.pmda.go.jp/english/events/3rd_pmda_training_seminar.html
Trainings for individual Trainees
Mid and short-term training
Medium-term trainingMay~July 2010: 2.5 months training for a SFDA reviewer
Dec 2011: Three weeks training for three KFDA officials on general issues
Feb 2012: One month training for TFDA (Taiwan FDA) officials on Medical Devices
Mar 2013: One week training for Indonesian NADFC officials on pharmaceuticals
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Dr. Kondo with Trainees from KFDA Dr. Kondo with Trainees from Taiwan FDA
To Improve Public Health
Review Safety Relief
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Th kThank you
ffor
tt ti !your attention!
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