Role and Vision of PMDA

Role and Vision of PMDA ~Promoting Global Public Health~ Taisuke Hojo Senior Executive Director Pharmaceutical and Medical Devices Agency (PMDA) 1 st Malaysia-Japan Symposium March 10 th, 2015

Today s Topics 1. Introduction of PMDA 2. Our Major Services i. Review Services ii. iii. Post-marketing Safety Measures Relief Services for Adverse Health Effects 3. PMDA s International Activities 4.Conclusion 2

Today s Topics 1. Introduction of PMDA 2. Our Major Services i. Review Services ii. iii. Post-marketing Safety Measures Relief Services for Adverse Health Effects 3. PMDA s International Activities 4.Conclusion 3

Pharmaceuticals and Medical Devices Agency Date of Establishment : April 2004 4 Major Services Scientific Review for Drugs & Medical Devices GCP, GMP Inspection Consultation on Clinical Trials Safety Measures Relief Services Unique Three-pillar System Securing Nation s Safety Review Kansai Branch Safety Japanese citizens Relief 4

Work Flow of Drugs Development R & D Non-Clinical Study Clinical Trial Application Post-marketing GLP Inspection GCP Inspection GMP/QMS Inspection GPSP/GVP Inspection R&D Promotion Clinical Trial Consultation Review Post-marketing Safety Operations Relief National Institute of Biomedical Innovation (Established in April 2005) Health Policy Bureau MHLW Pharmaceuticals and Medical Devices Agency (Established in April 2004) Review Report Approval Minister of Health Labour and Welfare (Pharmaceutical and Food Safety Bureau) Recall Orders etc. Pharmaceutical Affairs and Food Sanitation Council (PAFSC) 5

Organization of PMDA Associate Center Director Office of Regulatory Science Executive Director Associate Executive Director Office of Standards and Guidelines Development Office of Review Administration Director of Center for Product Evaluation Associate Executive Director Office of Review Management Office of International Programs International Coordination/Liaison Officers Chief Executive Deputy Center Director (for Cellular and Tissuebased Products) Associate Center Director Associate Center Director Associate Executive Director Offices of New Drug I-V Office of Cellular and Tissue-based Products Office of Vaccines and Blood Products Offices of OTC/Quasi-Drugs Office of Generic Drugs Offices of Medical Devices I-III Auditor Auditor Deputy Center Director (for Medical Devices) Office of Conformity Audit Principal Senior Scientists Senior Scientists Associate Center Director Advanced Review with Electric Data Promotion Group Senior Executive Director Chief Safety Officer Kansai Branch Office of Manufacturing/ Quality and Compliance Offices of Safety I, II Associate Executive Director Information Technology Promotion Group Audit Office As of November 1, 2014 Executive Director Deputy Executive Director Chief Relief Officer Chief Management Officer Chief Actuary Office of Relief Funds Offices of General Affairs / Office of Financial Management / Office of Planning and Coordination

PMDA Staff Size 1200 1000 Administrative part Review Department Safety Department Planned 1065 800 600 521 605 648 678 708 753 400 256 291 319 341 426 200 0 2004.4 2005.4 2006.4 2007.4 2008.4 2009.4 2010.4 2011.4 2012.4 2013.4 2014.4 2018

Our Philosophy (September, 2008) PMDA continues to improve the public health and safety of our nation by reviewing applications for marketing approval of pharmaceuticals and medical devices, conducting safety measures, and providing relief to people who have suffered from adverse drug reactions. We conduct our mission in accordance with the following principles: We pursue the development of medical science while performing our duty with greater transparency based on our mission to protect public health and the lives of our citizens. We will be the bridge between the patients and their wishes for faster access to safer and more effective drugs and medical devices. We make science-based judgments on quality, safety, and efficacy of medical products by training personnel to have the latest technical knowledge and wisdom in their field of expertise. We play an active role within the international community by promoting international harmonization. We conduct services in a way that is trusted by the public based on our experiences from the past. 8

3 rd 5-year mid-term plan of PMDA (FY2014-2018) 4 Major challenges Shortening the time from early development to approval Measures: improvement in consultation system, accelerated review process, etc. High quality review/consultation services Measures: promotion of regulatory science research, etc. Enhancing safety measures Measures: utilization of medical information database Globalization Measures: information transfer with the world

Today s Topics 1. Introduction of PMDA 2. Our Major Services i. Review Services ii. iii. Post-marketing Safety Measures Relief Services for Adverse Health Effects 3. PMDA s International Activities 4.Conclusion 10

Team Reviewing at the PMDA Reviewers are required to have a high level of expertise Office Director Review Director Team Leader CMC Toxicology ADME Biostatistics Pharmacology Clinical Risk Manager 11

Japan s Performance on NDA Review Reference: The impact of the changing regulatory environment on the approval of new medicines across six major authorities 2004-2013. CIRS (Centre for Innovation in Regulatory Science) R&D 55 http://cirsci.org/node/73 12

Today s Topics 1. Introduction of PMDA 2. Our Major Services i. Review Services ii. iii. Post-marketing Safety Measures Relief Services for Adverse Health Effects 3. PMDA s International Activities 4.Conclusion 13

Adverse Drug Reaction (ADR) Reporting System in Japan Investigation Reporting Reporting Health Care Providers FAX Postal Mail Electronic reporting Analyze and evaluate collected data Feedback Marketing Authorization Holders (MAH) Pharmacies Safety Measures

Goal of MIHARI Project & MID-NET Create new DB = MID-NET 15

Today s Topics 1. Introduction of PMDA 2. Our Major Services i. Review Services ii. iii. Post-marketing Safety Measures Relief Services for Adverse Health Effects 3. PMDA s International Activities 4.Conclusion 16

Drug Risk & Relief Non-clinical study Clinical Trial Review Post-marketing Risk Benefit It is impossible to prevent risks completely even with benefit of Revolutionary technology Social Risk Proper usage Pharmaceutical Manufacturers, etc Social Relief System Contribution Relief Fund Relief benefits Medical costs Disability pension etc. Patients *Infectious Disease Relief Launched in April 2004 17

Today s Topics 1. Introduction of PMDA 2. Our Major Services i. Review Services ii. iii. Post-marketing Safety Measures Relief Services for Adverse Health Effects 3. PMDA s International Activities 4.Conclusion 18

Summit APEC LSIF RHSC Abbreviation Summit ICH IMDRF PIC/S HBD ICDRA APEC LSIF RHSC OECD MAD PDG IGDRP ICMRA ICH OECD Global Activities IMDRF PIC/S HBD ICDRA PDG Official Name International Summit of Heads of Medicines Regulatory Agencies International Conference on Harmonization International Medical Device Regulators Forum Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme Harmonization By Doing IDGRP ICMRA and more International Conference of Drug Regulatory Authorities APEC Life Science Innovation Forum Regulatory Harmonization Steering Committee OECD Mutual Acceptance of Data Pharmacopoeial Discussion Group International Generic Drug Regulators Pilot International Coalition of Medicines Regulatory Authorities

PMDA and the World Confidentiality Arrangement Memorandum of Understanding (MOU) Resident Staff Joint Symposium (forth coming) Health Canada, Canada FDA, US ANVISA, Brazil IMB, Ireland EMA(EU) MHRA, UK ANSM, France CBG-MEB, Netherlands AIFA, Italy Swissmedic, Switzerland CFDA, China TFDA, Thailand * HSA, Singapore PMDA Tokyo & Osaka, Japan Taiwan FDA, ** Taiwan NPCB, Malaysia NADFC, Indonesia TGA, Australia MOU between the Chinese SFDA (present CFDA) and the Japanese MHLW, under which PMDA supports cooperative activities ** MOU concluded between Interchange Association and East Asia Relations Commission, but is being implemented through cooperation of related organizations.

Dissemination of Information Review Report Safety Information PMDA Updates News Release And more 21

Training for Foreign Regulatory Officers PMDA Training Seminar Pharmaceuticals: 1st (Nov. 2010) Reviewing of New Drugs 2nd (Dec. 2011) GMP inspection 3rd (Jan. 2013) Post-Marketing Safety & Relief Services 4th (Feb. 2014) Reviewing of Generic Drugs Medical Devices: 1 st (Mar. 2014) Medical Device Regulation 2 nd (Feb. 2015) Individual Training (including OJT) NADFC (Indonesia) officials: 5 days, 2013 FDA (US) analyst: 6 months, 2014-2014 NPBC (Malaysia) officials: 1 month, 2014 Thai FDA (Thailand) officials: 5 days, 2014 2014 etc.

Today s Topics 1. Introduction of PMDA 2. Our Major Services i. Review Services ii. iii. Post-marketing Safety Measures Relief Services for Adverse Health Effects 3. PMDA s International Activities 4.Conclusion 23

Toward Global PMDA Approve innovative products first in the world! Strengthen post marketing safety measures Safety Review Japanese citizens Spread technology of Japanese origin world-wide Collaborate with review organizations globally Timely relief for acknowledged damage Health damage relief The society where people can receive necessary healthcare services at the most advanced level Extend healthy life expectancy for Japanese citizens Contribute to global healthcare 24

Thank you very much for your attention. http://www.pmda.go.jp/english/index.html 25