PMDA Update: Its current situation and future direction Tatsuya Kondo, M.D. Ph.D. Chief Executive Pharmaceuticals and Medical Devices Agency (PMDA), Japan 25th Annual EuroMeeting 4-6 March 2013 RAI, Amsterdam Netherlands Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. ( DIA ), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners. 2
Contents PMDA Update; Its current situation and future direction 1. Organization 2. Activities iti in Medicinal i Products 3. Activities in Medical Devices 4. International Activities 3 PMDA s Safety Triangle Unique Three-pillar System Securing Nation s Safety Review Reduction in Risk Safety Continuous risk mitigation efforts Japanese Citizens Relief Relief measures for health damage caused by risk factors 4
PMDA Staff Size 800 700 Administrative i ti part Safety Department 600 Review Department 500 Planned 426 521 605 648 678 751 400 300 256 291 319 341 200 100 0 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 5 Major Changes Special Assistant for Chief Executive (Feb. 2012) Office of Review Innovation (Apr. 2012) Science Board (May 2012) of Center for Product Evaluation appointed (June 2012) Placed 2 Deputy Center s (June 2012) Reorganization of Office of Biologics (October 2012) 6
Organization Chart of PMDA Auditor Auditor Audit Office Chief Executive Executive Chief Relief Officer Chief Management Officer Chief Relief Officer Associate Center Associate Executive Associate Executive Center of Center for Product Evaluation Associate Center Deputy Center (for Cellular and Tissue-based Products) Associate Executive Deputy Center (for Medical Devices) Senior Executive Chief Safety Officer Offices of General Affairs / Office of Financial Management / Office of Planning and Coordination Office of Relief Funds Office of Regulatory Science Office of Standards and Guidelines Development Office of Review Administration Office of Review Management Office of International Programs / International Liaison Officers Office of New Drug Ⅰ - Ⅴ Office of Cellular and Tissue-based Products Office of Vaccines and Blood Products Office of OTC/Generic Drugs Office of Medical Devices Ⅰ-Ⅲ Office of Conformity Audit Principal Senior Scientist / Senior Scientists Office of GMP/QMS Inspection Office of Safety Ⅰ, Ⅱ 7 Contents PMDA Update; Its current situation and future direction 1. Organization 2. Activities iti in Medicinal i 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) FY2012 Target Total lreview Time (Month) 15.4 11.9 92 9.2 65 6.5 61 6.1 9 Regulatory Review Time 7.3 3.6 4.9 4.2 3.9 6 Applicant's time 68 6.8 64 6.4 34 3.4 20 2.0 11 1.1 3 Standard Review Products FY 2008 FY 2009 FY 2010 FY 2011 FY 2012 (As of Oct) FY 2012 Target Total Review Time (Month) 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 74 7.4 67 6.7 64 6.4 51 5.1 39 3.9 3 9 Pharmaceutical Affairs Consultation on R&D Strategy Valley of Death -Short of funds, Knowledge on Regulation and development strategy Basic Research Pharmaceutical and Medical Devices candidates Strategic Consultation Quality Study Consultation on quality or toxicity study of biologics, cell-and tissue-based products Non- Clinical Study Clinical Trial Up to the level of fpoc studies Practical Use Innovative Products originated from Japan * Further studies are handled by the Regular Consultation Consultation on endpoints or sample size of early clinical trial 10
Science Board Science Board Committee members: External experts from Academia Not involved in the Review Process of individual products Committee Recommendation on 1. Review policy for innovative medical products 2. Development of guidelines 3. Regulatory Science Research 4. Personnel exchanges between PMDA and Academia 5. Election of External review experts 6. Improvements in the scientific aspects of review Subcommittee Deliberation on problems in each field Collaboration with PMDA working team (RS research, guideline development, etc.) Pharma- ceuticals Medical Devices Bio-based products Cell- & tissue- Based products 11 Promotion of personnel exchange human resource development NIHS Reviewers Researchers Universities and research institutions Medical Institutions Acquisition of innovative technologies Speed up and improve product review Outcome of researches Fostering of Regulatory Scientist Promotion of appropriate R & D Develop standards d and guidelines at early phase Facilitate practical application of innovative technologies Decrease drug /device lag
Improving Safety Measures Collection of Information Analysis Assessment of Safety measure effects New Risk management system Planning and Implementation of Safety measures Hypothesis Evaluation of hypothesis Crisis management Goal Prevention of serious drug safety-related crisis from Japan Effective encouragement of proper drug use. Ensuring credibility to post-market safety management system. Contents PMDA Update; Its current situation and future direction 1. Organization 2. Activities iti in Medicinal i products 3. Activities in Medical devices 4. International Activities 14
Medical Device Procedure Mt Material il Indication treatment Form diagnostic Medical Devices Regulation EU Japan US Brazil Canada Singapore Notified body certification (requirements depend on device classification) Class III, IV: Minister s approval Class II: Notified body certification Class I: Selfdeclaration Pre-market review Class III: PMA Approval Class II: 510(k) clearance, Class I: exemption Class III, IV: Registro to ANVISA Class II, III, IV: License from Health Canada Class I, II: Cadastro to ANVISA Class I: exemption Class B, C, D: Registration to HAS Class A: exemption Governmental approval/license Notified body review/certification Self declaration
Harmonization By Doing (HBD) Activity between Japan and USA to develop global clinical trialsand and address regulatory barriers that maybe impediments to timely device approvals. (since 2003) Steering Committee FDA MHLW/PMDA DCRI JAG AdvaMed JFMDA Guidance/Suggestion Report, Request Working Groups WG1:Global Cardiovascular Device Trials WG2: Study on Post market Registry WG3:Clinical Trials Infrastructure and Methodology WG4: 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; Its current situation and future direction 1. Organization 2. Activities iti in Medicinal i products 3. Activities in Medical devices 4. International Activities 19 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 Enhance human resource exchange / Cultivate employees with international minded and communication skills Improve International PR activities / information transmission
Dissemination of Information Review Report Safety Information PMDA Updates News Release And more 21 The First Indonesia-Japan Symposium Date: February 13, 2013 Venue: Jakarta, Indonesia Focus 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) Gabungan Perusahaan Farmasi Indonesia (GPFI) 22
3rd PMDA Training Seminar 2013 January 21-25 Post-Marketing Safety & Relief Services 18 trainees from 6 countries: Korea, Taiwan, Indonesia, Singapore, Brazil, Ukraine Website: http://www.pmda.go.jp/english/events/ pmda 3rd_pmda_training_seminar.html 23 Trainings for individual Trainees Mid and short-term training May~July 2010: 2.5 months training for a SFDA reviewer Dec 2011: Medium-term Three weeks training 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 Dr. Kondo with Trainees from KFDA Dr. Kondo with Trainees from Taiwan FDA 24
To Improve Public Health Review Safety Relief 25 Thank you for your attention! ti 26