Regulatory Framework in Japan - Past and Future - Building a Regulatory Framework Essential Elements of Compliance / Surveillance
|
|
- Imogene Rogers
- 6 years ago
- Views:
Transcription
1 Regulatory Framework in Japan - Past and Future - Building a Regulatory Framework Essential Elements of Compliance / Surveillance Nobuo UEMURA Director Office of Medical Devices III Pharmaceuticals and Medical Devices Agency (PMDA)
2 Disclaimer The views and opinions expressed in the following Power Point slides and the presentation are those of the individual presenter, and do not necessarily represent the formal position of PMDA and MHLW. The amendment law has just been passed last month by the Parliament, and the precise and detailed regulations will be announced from now on. 2
3 Agenda 1. Current Regulatory Framework in Japan 2. History of medical device regulation in Japan 3. Major Topics in the next revision of PAL 1 Third party certification system 2 Quality Management System (QMS) 3 Other revisions related to medical devices 4 Regenerative and Cellular Therapy Products, and Gene Therapy Products 4. Final message 3
4 Ministry of Health Labor & Welfare (MHLW) & Pharmaceuticals & Medical Devices Agency (PMDA) Imperial palace Kasumigaseki Ministry H. L. W. PMDA 10 min. by walk 4 4
5 Role of MHLW and PMDA MHLW Ultimate Responsibilities in policies & administrative measures PMDA ex. Final judgment on approval Product withdrawal from market Actual review, examination, data analysis, etc. to assist MHLW s measures ex. Approval Review of MDs QMS/GLP/GCP inspection Collection and analysis of Adverse Event Reports 5
6 Outline of approval review process (Brand-new medical device) Consultation Applicant Application PAFSC: Pharmaceutical Affairs and Food Sanitation Council PMDA Conformity Audits ( GLP/GCP/QMS etc. ) + External Experts MHLW Advisory body PAFSC Scientific Review Review Consultation Advice Inquiry Answer Report Minister Approval 6
7 Overview of Medical Device Regulation in Japan Classification (According to the GHTF classification) Class I Class II Class III Class IV Extremely low risk Low risk Medium risk High risk Example X-Ray film MRI Dialyzer, Artificial bone Pacemaker, Artificial heart valve Category General MDs Controlled MDs Specially controlled MDs Review regulation Self-declaration Third party certification QMS inspection No requirement Registered notification body Post-market safety vigilance/surveillance PMDA and MHLW Minister s approval (PMDA s review) PMDA or Prefecture Gov. 7
8 Medical Devices Regulation EU Japan US Pre-market review Notified body certification (requirements depend on device classification) Class IV: Minister s approval Class III: Minister s approval Class II: Notified body certification Class III: PMA Approval Class II: 510(k) clearance, Class I: Self-declaration Class I: exemption Self declaration Notified body review/certification Governmental approval/license 8
9 Agenda 1. Current Regulatory Framework in Japan 2. History of medical device regulation in Japan 3. Major Topics in the next revision of PAL 1 Third party certification system 2 Quality Management System (QMS) 3 Other revisions related to medical devices 4 Regenerative and Cellular Therapy Products, and Gene Therapy Products 4. Final message 9
10 History of Review System Transition in Japan Commissioned new activities to OPSR MHW Commissioned new activities to JAAME Establishment of PMDEC at NIHS PMDEC/NIHS Introduction of Team Review Establishment of PMDA MHLW GHTF 1992 OPSR (KIKO) Drug Equivalency Review JAAME Device Equivalency Review OPSR (KIKO) Clinical Trial Consultation Compliance Audit GCP Inspection PMDA Device:Ca140 Transition of Number of Review Resources (incl. MHW, JAAME,OPSR,PMDEC,MHLW,PMDA) 89 (1994) 99(1995) 121(1996) 241(1999) 311(2004) > 650 Note) Numbers indicated here stand for sum of the officials of Drugs and Medical Devices Review and Vigilance (including administrators & reviewers) 10
11 Quantitative Increase and Background of Medical Device Reviewers 90 reviewers As of Sep Total 98 reviewers M:13, V: 2, B:12, P:34, E:35, O: 2 11
12 Japan s Medical Device regulations and international guidance documents Revision of Pharmaceutical Affairs Law (PAL) in 2002 (enforced in 2005 ) GHTF classification rule (SG1-N15) GMDN 2003 JMDN Essential Principles (EPs) + Check lists STED (GHTF-based) GCP/GLP OECD-GLP, ICH-GCP/ISO14155:
13 Regulations on medical device, based on risk GHTF Classification PAL classification Category Pre-market regulation Japanese MD Nomenclature Class A extremely low risk X-Ray film General MDs ( Class I ) Self Declaration 1,195 Class B low risk MRI, Digestive catheters Controlled MDs ( Class II ) Third party Certification 1,799 (1,367 for 3 rd Party) Class C Class D medium risk Artificial bones, Dialyzer high risk Pacemaker, Artificial heart valves Specially Controlled MDs ( Class III & IV ) Minister s Approval (Review by PMDA) As of July,
14 1. Classification of Medical Devices Former Regulation Current Regulation (From April 2005) GHTF Classification Approval is not necessarily General MDs ( Class I ) Self declaration Class A extremely low risk X-Ray film Controlled MDs ( Class II ) Third party Certification (in principle) Class B low risk MRI, Digestive catheters Minister s Approval is needed Specially Controlled MDs ( Class III & IV ) Minister s Approval Class C medium risk Artificial bones, Dialyzer Class D high risk Pacemaker, Artificial heart values 14
15 2. Japanese Medical Devices Nomenclature (JMDN) and MD classification Each MD has to fall under generic nomenclature (JMDN). JMDN is based on 2003 version of GMDN. Ministerial Notification #298 (July 20, 2004) shows lists of JMDN and their classification. Classification rule is based on GHTF document (SG1-N15). 15
16 3. The Essential Principles (EPs) (benefit) EPs provide clear requirements for MDs. (barrier) EPs were new requirements and big challenges especially for SMEs. Two step approach for introducing. - Until April 2008, the General Requirements only - Then, the Design and Manufacturing Requirements Industry has drafted ; - around 400 checklists for conformity to EPs for class II (GHTF class B) MDs, product by product checklists for class III, IV (GHTF class C, D) MDs 16
17 Structure of Product Standards Contents of certification standard (MHLW Ministerial Notification) 1. Scope Applicable medical devices are defined by Japanese Medical Device Nomenclature (JMDN). 2. Technical standard Japan Industrial Standards (JIS) 3. Intended use and indications Most of JIS are harmonized with ISO/IEC The intended use and indications for a medical device are determined based on its definition given in the JMDN. Conformity to Essential Principles (MHLW-PFSB, Notification) The Essential Principles conformity checklist is also provided for confirming the conformity to the Essential Principles. (The Essential Principles are designated by MHLW Ministerial Notification.) 17
18 3. Essential Principles and 4. STED - Application Dossier - Application Form (Form22-3 of Ministerial Ordinance on PAL) STED + + Data set Declaration of Conformity with EP Essential Principles from GHTF were introduced in Japanese regulation (PAL Art.41(3)) and any device shall be in conformity with the EPs. GHTF-based STED is required. Since 2002 : STED(PD) a trial basis for new or improved MDs. Since 2005 : STED(PD) mandatory for application. 18
19 5. GLP/GCP Good Laboratory Practice (GLP) for MD J-GLP Ministerial Ordinance incorporated OECD-GLP in 2005 Good Clinical Practice (GCP) for MD J-GCP Ministerial Ordinance incorporated ICH-GCP(ICH E6 guideline) in 2005 and ISO14155:2011 in
20 Agenda 1. Current Regulatory Framework in Japan 2. History of medical device regulation in Japan 3. Major Topics in the next revision of PAL 1 Third party certification system 2 Quality Management System (QMS) 3 Other revisions related to medical devices 4 Regenerative and Cellular Therapy Products, and Gene Therapy Products 4. Final message 20
21 The Japan Revitalization Strategy June 2013 [Three Policies] Aggressive monetary policy (first arrow) New Growth Strategy (third arrow) Flexible fiscal policy (second arrow) [Three Plans] Plan for the Revitalization of Japanese Industry Strategic Market Creation Plan Strategy of Global outreach Extend healthy life expectancy Expand the markets for pharmaceuticals, medical devices, and regenerative medicine-related industries 21
22 Brief overview of revision of PAL Points of this amendment are to; 1. Strengthen safety measures regarding drugs and medical devices 2. Revise medical device regulations based on its characteristics 3. Introduce Regenerative and Cellular Therapy Products (RCTP) & Gene Therapy Products (GTP) regulations based on their characteristics Name of PAL will be changed to Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics. The chapter for Medical Device will be prepared. 22
23 Scope of Third Party Certification will be expanded GHTF Classification Category PAL classification Pre-market regulation Japanese MD Nomenclature Class A extremely low risk X-Ray film General MDs (Class I) Self declaration 1,195 Class B low risk MRI, digestive catheters Controlled MDs (class II) Third party Certification 1,799 (1,367 for 3 rd Party) Class C Class D medium risk artificial bones, dialyzer high risk pacemaker, artificial heart valves Specially Controlled MDs (class III & IV) Minister s Approval (Review by PMDA)
24 Framework of Approval Review and QMS Inspection Pre-approval Post-approval Application Form Partial Change Application Submission of Application Form Review by Review Divisions Market Approval Minor Change Notification 軽微変更届出 Design transfer to manufacturing site QMS inspection before approval Actual production Market Release QMS inspection every 5 years after approval 24
25 QMS regulation change under the revision of PAL QMS inspection applied to Market Authorization Holder(MAH) Foreign manufacturer s Accreditation to Registration QMS inspection per product family
26 QMS inspection will be applied to MAH, not each manufacturer [Current QMS] [Future QMS] Marketing Authorization Holder (MAH) GQP QMS Marketing Authorization Holder (MAH) Plant A in USA QMS Plant B in Tokyo QMS PMDA Tokyo Plant A in USA Plant B in Tokyo PMDA or Third Party Plant C in Osaka Plant C in Osaka QMS Osaka 26
27 Registration of Foreign Manufacturer Foreign manufacturer need to register until the QMS inspection is conducted. Accreditation of foreign manufacturer would change to Registration. Accreditation Registration Manufacturing License would change to Registration. License for inland manufacturing Registration
28 QMS inspection per product family Now Ex) Product A, B,C are Product family XXX QMS Inspection per Product A, B and C After the revision of PAL QMS Inspection per Product family XXX QMS inspection per product family manufactured by the same establishments.
29 Standalone Medical Device Software (SMDS) will be regulated by the revised PAL Current PAL Image Diagnostic Apparatus It processes, stores and displays image data from CT, MRI etc. Future SMDS Hardware Software (program) Software (program) Only combination of hardware and software is regulated. Standalone Software will also be regulated. 29
30 Outcome examination system, instead of re-examination system, will be introduced Outcome examination system Outcomes (efficacy and safety) of a designated medical device under a postmarketing surveillance for an appropriate period will be examined. Current [Scope] All brand-new medical devices Future Review [Scope] Designated medical devices ex) Implantable medical devices like stent Approval Annual report Annual report Re-examination period Orphan 7 years New structure 4 years Others 3 years Post-marketing surveillance Outcome examination period Designated Period Not necessary to start the period just after approval Application for re-examination Application for outcome examination 30
31 Regulations on Package Insert will become more reasonable 1. Contents of package insert of class IV medical device should be notified to MHLW in advance. 2. Package insert notified will be uploaded on web-site. 3. Draft of package insert will be required as a material in a new medical device application. 4. Paper package insert of any medical devices can be omitted under certain conditions. 31
32 Regenerative and Cellular Therapy Products(RCTP), and Gene Therapy Products(GTP) will be newly categorized [Current] [Future] Drug RCTP GTP Drug Medical Device RCTP GTP Medical Device Regenerative and Cellular Therapy Products (RCTP) & Gene Therapy Products (GTP) 32
33 Agenda 1. Current Regulatory Framework in Japan 2. History of medical device regulation in Japan 3. Major Topics in the next revision of PAL 1 Third party certification system 2 Quality Management System (QMS) 3 Other revisions related to medical devices 4 Regenerative and Cellular Therapy Products, and Gene Therapy Products 4. Final message 33
34 Ideal Picture of Medical Device Regulation Collaboration among Industry, Regulatory Authorities(Government), Academia, and People in public with recognition of each parties obligations and responsibilities Industry Academia People Regulatory Authorities 34
35 Thank you MHLW PMDA
Japan Update - Implementation of PMD Act - March, 2015
Japan Update - Implementation of PMD Act - March, 2015 Topics Implementation of PMD Act; Revision of Pharmaceutical Affairs Law (PAL) PMDA Medical Device Training Seminar 2 Implementation of PMD Act: The
More informationCurrent Challenges of Regulation in Japan - Amendment of Pharmaceutical Affairs Act
Current Challenges of Regulation in Japan - Amendment of Pharmaceutical Affairs Act Hiroshi Yamamoto, MS Chief Safety Officer Pharmaceuticals and Medical Devices Agency (PMDA), Japan 26th Annual EuroMeeting
More informationMedical Device Product Innovation
Medical Device Product Innovation Madoka Murakami PMDA, Japan AMDC Industry Training, 3-5 Oct 2017, Surabaya Agenda Introduction of PMDA Medical Device TPLC and Quality Management Typical Nonconformities
More informationNew Direction of Japanese Regulations on MD/IVD. - Japan Update -
New Direction of Japanese Regulations on MD/IVD - Japan Update - Topics Collaboration plan to accelerate review of MDs Revision of Pharmaceutical Affairs Law (PAL); Implementation of PMD Act. 2 Collaboration
More informationCMC Workshop CMC Challenges in Japan. April Bethesda, MD. Yoshihiro Matsuda, Ph.D., PMDA Session 10
CMC Workshop 2015 April 13-15 Bethesda, MD CMC Challenges in Japan Yoshihiro Matsuda, Ph.D., PMDA Session 10 Disclaimer The views and opinions expressed in the following PowerPoint slides are those of
More informationCurrent Situation and Updates of QMS Inspection in Japan. Office of GMP/QMS Inspection Pharmaceuticals and Medical Devices Agency
Current Situation and Updates of QMS Inspection in Japan Office of GMP/QMS Inspection Pharmaceuticals and Medical Devices Agency 1 Application Form Framework of Approval Review and QMS Inspection on Medical
More informationCurrent Status and Perspectives on Pharmaceutical Products in Japan
Current Status and Perspectives on Pharmaceutical Products in Japan Yoshihiro Matsuda, Ph.D. Deputy Division Director Office of Standards and Guidelines Development Pharmaceuticals and Medical Devices
More informationHandling of Marketing Application for Combination Products
October 24, 2014 To: Commissioner of Prefectural Health Department (Bureau) N o t i f i c a t i o n PFSB/ELD Notification No. 1024-2 PFSB/ELD/OMDE Notification No. 1024-1 PFSB/SD Notification No. 1024-9
More informationGCP/Clinical Investigation in Japan
GCP/Clinical Investigation in Japan 27-28 August, 2018 Shinwa Shibata Office of Non-clinical and Clinical Compliance Pharmaceuticals and Medical Devices Agency 1 Today s Agenda 1. Japanese-GCP (J-GCP)
More informationPre-consultation system at the authority for clinical trials and NDA in Japan
Pharmaceuticals and Medical Devices Agency Pre-consultation system at the authority for clinical trials and NDA in Japan Takeyuki SATO Associate Director, Centre for Product Evaluation Pharmaceuticals
More informationContents. 1. Administrative Organizations and Affairs under Jurisdiction for Veterinary Medical Devices
Assurance System of Quality, Performance, and Safety of Veterinary Medical Devices Based on the Law for Ensuring the Quality, Efficacy, and Safety of Drugs and Medical Devices Animal Products Safety Division
More informationTo: Prefectural Governors From: Director-General, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare
Provisional Translation (as of March 2010) PFSB (Yakushoku) Notification No. 0216002 February 16, 2005 To: Prefectural Governors From: Director-General, Pharmaceutical and Food Safety Bureau, Ministry
More informationComparative Overview of Other Medical Devices Regulatory Systems
Comparative Overview of Other Medical Devices Regulatory Systems Dr David Jefferys, BSc MD, FRCP, FFPM Medical Device Expert Senior Vice President Global Regulatory, Healthcare Policy and Corporate Affairs
More informationQuestion & Answer for Challenges in Product Registration Process for Medical Device in Taiwan and Japan.
2018.11 Question & Answer for Challenges in Product Registration Process for Medical Device in Taiwan and Japan. Product Registration WG This Q&A was made for better understanding of regulations and product
More informationConditional Early Approval System for Innovative Medical Device Products (Fast-Break Scheme)
PSEHB Notification No. 0731-1 July 31, 2017 To: Prefectural Governors Director-General of the Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare (Official seal
More informationRecent Update of Medical Products Regulation in Japan
Recent Update of Medical Products Regulation in Japan Masatoshi Narita Councillor for Pharmaceutical Affairs Minister s Secretariat Ministry of Health, Labour and Welfare (MHLW), Japan 2nd Joint conference
More informationRegulatory Perspectives of Japan
International Alliance for Biological Standardization (IABS) Challenge Toward Sound Scientific Regulation of Cell Therapy Products at Kyoto International Conference Center, Kyoto, Japan Regulatory Perspectives
More informationCHAPTER 3 DRUG DEVELOPMENT. 1.1 Development of New Drugs 1. PROCESS FROM DEVELOPMENT TO APPROVAL
CHAPTER 3 DRUG DEVELOPMENT indications, which are clearly different from those of drugs, which have already been approved for manufacture and marketing. 1.1 Development of New Drugs 1. PROCESS FROM DEVELOPMENT
More informationINFORMATION ON JAPANESE REGULATORY AFFAIRS
2017 INFORMATION ON JAPANESE REGULATORY AFFAIRS Regulatory Information Task Force Japan Pharmaceutical Manufacturers Association Pharmaceutical Administration and Regulations in Japan Japan Pharmaceutical
More informationCHAPTER 3 Drug Development
CHAPTER 3 Drug Development 1. PROCESS FROM DEVELOPMENT TO APPROVAL New drugs are defined as drugs with active ingredients, dosage, administration route, or indications, which are clearly different from
More informationRegulatory frameworks of regenerative medicines and products review in Japan
Regulatory frameworks of regenerative medicines and products review in Japan August 27th, 2018 Kenji KUROIWA Deputy Director, Medical Devices Evaluation Division Ministry of Health, Labour and Welfare,
More informationBy: K.L. Sharma, Joint Secretary to the Government of India, Ministry of Health and Family Welfare
By: K.L. Sharma, Joint Secretary to the Government of India, Ministry of Health and Family Welfare Presently, The quality, safety and efficacy of notified medical devices manufactured, imported and sold
More informationKorean Medical Devices Regulations
Korean Devices Regulations The Ministry of Health and Welfare (MHW) is the healthcare agency having overall responsibility for Devices. The Korea Food and Drug Administration (MFDS), an agency under MHW,
More informationNew Regulation in Japan and Future Direction of PMDA. Tatsuya Kondo, M.D., Ph.D. Chief Executive Pharmaceuticals and Medical Devices Agency (PMDA)
New Regulation in Japan and Future Direction of PMDA Tatsuya Kondo, M.D., Ph.D. Chief Executive Pharmaceuticals and Medical Devices Agency (PMDA) 1 Disclaimer The views and opinions expressed in the following
More informationOrphan Designation System in Japan. 10, March 2014 Ministry of Health, Labour and Welfare
Orphan Designation System in Japan 10, March 2014 Ministry of Health, Labour and Welfare Background of the Orphan Designation System Before the system had been implemented, the R&D on medicines for rare
More informationDirector of Evaluation and Licensing Division Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare
Provisional translation (as of March 27, 2008) 1 PFSB / ELD Notification No. 0210004 February 10, 2005 *Revised in accordance with PFSB / ELD Notification No. 0619004 June 19, 2007 Director of Evaluation
More informationCHAPTER 2 PHARMACEUTICAL LAWS AND REGULATIONS 1. PHARMACEUTICAL LAWS 2. PHARMACEUTICAL AND MEDICAL DEVICE ACT
CHAPTER 2 PHARMACEUTICAL LAWS AND REGULATIONS 1. PHARMACEUTICAL LAWS Pharmaceutical administration in Japan is based on various laws and regulations, consisting mainly of: (1) Pharmaceutical and Medical
More informationPost-Approval CMC Changes in Japan: How We Envision the Future
CMC Strategy Forum Summer 2016, July 18-21, 2016, Gaithersburg Marriott Washingtonian Center, Gaithersburg, MD, USA Post-Approval CMC Changes in Japan: How We Envision the Future Yasuhiro Kishioka, Ph.D.
More informationCHAPTER 2 PHARMACEUTICAL LAWS AND REGULATIONS 1. PHARMACEUTICAL LAWS 2. PHARMACEUTICAL AND MEDICAL DEVICE ACT
CHAPTER 2 PHARMACEUTICAL LAWS AND REGULATIONS 1. PHARMACEUTICAL LAWS Pharmaceutical administration in Japan is based on various laws and regulations, consisting mainly of: (1) Pharmaceutical and Medical
More informationContents. Regulatory Bodies... 13
Contents UNITED STATES... 3 Regulatory Bodies... 3 Product Classification and Regulatory Control... 3 Application Documents... 3 Quality System Requirements... 4 Product and Manufacturer s License... 4
More informationTHE 2005 PHARMA, BIOTECH AND DEVICE COLLOQUIUM THE INTERNATIONAL DRUG SAFETY PARADIGM
THE 2005 PHARMA, BIOTECH AND DEVICE COLLOQUIUM THE INTERNATIONAL DRUG SAFETY PARADIGM June 7, 2005 Shinya Yamauchi Otsuka Pharmaceutical Co., Ltd. 1 Outline Revision of Japan s Pharmaceutical Affairs Law
More informationCurrent GMP Inspection of PMDA. Shingou SAKURAI, Ph.D Office of Compliance and Standards Pharmaceuticals and Medical Devices Agency(PMDA), JAPAN
Current GMP Inspection of PMDA Shingou SAKURAI, Ph.D Office of Compliance and Standards Pharmaceuticals and Medical Devices Agency(PMDA), JAPAN GMP Inspection related Organizations in Japan Organizations
More informationQMS regulation in Japan. Office of Manufacturing/Quality and Compliance As of 1st April, 2015
QMS regulation in Japan Office of Manufacturing/Quality and Compliance As of 1st April, 2015 Manufacturing/Quality and Compliance Manufacturing/Quality and Compliance QA of GMP/QMS GMP QMS KANSAI Branch
More informationImplementation of 2005 Pharmaceutical Affairs Law and ICH Q8-Q10 in Japan
JCCT workshop on Q8/Q9/Q10 Beijing Implementation of 2005 Pharmaceutical Affairs Law and ICH Q8-Q10 in Japan Yukio HIYAMA Chief, 3 rd Section, Division of Drugs National Institute of Health Sciences, Ministry
More informationINFORMATION IN ENGLISH ON JAPAN REGULATORY AFFAIRS. English Regulatory Information Task Force, Japan. Pharmaceutical Manufacturers Association
2006.3 INFORMATION IN ENGLISH ON JAPAN REGULATORY AFFAIRS English Regulatory Information Task Force, Japan Pharmaceutical Manufacturers Association Pharmaceutical Administration and Regulations in Japan
More informationRisk Management Plan Guidance
1 / 17 Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare Translated by Office of Safety Ⅰ, Pharmaceuticals and Medical Devices Agency This English version is intended to be
More informationINFORMATION ON JAPANESE REGULATORY AFFAIRS
2018 INFORMATION ON JAPANESE REGULATORY AFFAIRS Regulatory Information Task Force Japan Pharmaceutical Manufacturers Association Pharmaceutical Administration and Regulations in Japan Japan Pharmaceutical
More informationTrial acceptance of MDSAP audit reports in Japan
Trial acceptance of MDSAP audit reports in Japan Pharmaceuticals and Medical Devices Agency (PMDA), Office of Manufacturing / Quality and Compliance March 2018 1 Japan s participation to MDSAP International
More informationIndex Day reports (ADR)...59, 125
Index 15-Day reports (ADR)...59, 125 30-Day reports (ADR)...126 7-Day reports (ADR)...59 ADR reporting system Reporting by pharmaceutical companies...125 ADR Reporting System Reporting by MHLW...124 Advanced
More informationFirst Global Forum on Medical Devices Bangkok-Thailand, September Regulatory Control of Medical Devices in Tanzania
First Global Forum on Medical Devices Bangkok-Thailand, September 9-11 2010 Regulatory Control of Medical Devices in Tanzania Mr. Hiiti Sillo Ag. Director General Tanzania Food and Drugs Authority hiiti@yahoo.com/hiiti.sillo@tfda.or.tz
More informationPharmaceuticals and Medical Devices Agency, Japan. Profile of Services
Pharmaceuticals and Medical Devices Agency, Japan Profile of Services 2017-2018 Our Philosophy PMDA continues to improve the public health and safety of our nation by reviewing applications for marketing
More informationApproval Review of Generic Drugs. Office of Generic/OTC Drugs, PMDA Kazuyuki SAITO, Ph.D.
Approval Review of Generic Drugs Office of Generic/OTC Drugs, PMDA Kazuyuki SAITO, Ph.D. Outline of Presentation Introduction Approval Review of Generic Drugs Equivalency review Conformity audit Conclusion
More informationCurrent Situation of Regulations and Premarket Review in Future of Companion Diagnostics in Japan
Current Situation of Regulations and Premarket Review in Future of Companion Diagnostics in Japan Daisei Miyamoto Pharmaceuticals and Medical Devices Agency(PMDA) Review Director, Office of Medical Devices
More informationPMDA Perspectives Yoshihiro Matsuda, Ph.D.
PMDA Perspectives Yoshihiro Matsuda, Ph.D. Office of Standards and Guidelines Development Pharmaceuticals and Medical Devices Agency (PMDA) 1 Introduction of PMDA NAME: Pharmaceuticals and Medical Devices
More informationRegulatory Updates in Taiwan
6th Joint Conference of Taiwan and Japan on Medical Products Regulation Regulatory Updates in Taiwan Shou-Mei Wu, Taiwan Food and Drug Administration Oct. 11, 2018 Outlines 01 02 03 04 05 06 Mission, Vision,
More informationDEVELOPMENT PROCESS OF HIGH-LEVEL MEDICAL PRODUCT
EMERGING TECHNOLOGY AND REGULATIONS OF MEDICAL DEVEICE IN ASIA-PACIFIC REGION October 29-30, 2013 IN TAIPEI DEVELOPMENT PROCESS OF HIGH-LEVEL MEDICAL PRODUCT IN JAPAN TAKING THE CORONARY STENT CASE October
More informationRisk Management Plan templates and instructions for authors
Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare Translated by Office of Safety I, Pharmaceuticals and Medical Devices Agency This English version is intended to be a reference
More informationJapanese Pharmacopoeia s Challenge to the Globalization
Japanese Pharmacopoeia s Challenge to the Globalization Naoyuki Yabana, Ph.D. Division of Pharmacopoeia and Standards for Drugs, Office of Standards and Guidelines Development, Pharmaceuticals and Agency
More informationRegulatory Reform for Regenerative Medicine in Japan
Pharmaceuticals and Medical Devices Agency Regulatory Reform for Regenerative Medicine in Japan Daisaku Sato, PhD. Director, Office of Cellular and Tissue-based Products Pharmaceuticals and Medical Devices
More informationof Innovative Pharmaceuticals* and Takao Inoue 4
26G-ISMS44 Regulatory Science for R&D Promotion Kazuhiko Mori 1, Takao Yamori 2, Toru Kawanishi 3, 1 Ministry of Health, Labor and Welfare (MHLW), 2 Pharmaceuticals and Medical Devices Agency (PMDA), 3
More informationOutline of Regulation System of Veterinary Medicinal Products (VMPs) in Japan
Outline of Regulation System of Veterinary Medicinal Products (VMPs) in Japan -To ensure quality, efficacy and safety of VMPs based on the Pharmaceutical Affairs Law - Animal Products Safety Division,
More informationICH Q12 (Pharmaceutical Product Lifecycle Management): PMDA Perspective
ISPE Japan Affiliate 2016 Annual Meeting, April 14-15, 2016, Tower hall Funabori, Tokyo, Japan ICH Q12 (Pharmaceutical Product Lifecycle Management): PMDA Perspective Yasuhiro Kishioka, Ph.D. Principal
More informationMedical Device Regulatory Roadmap SAMED Conference 2-3 December 2015
Medical Device Regulatory Roadmap SAMED Conference 2-3 December 2015 Dr J. Gouws Registrar of Medicines Status in RSA: 2 December 2015 Legislation: Bill 6D, 2014 Defines MD and IVDs Licensing of Manufacturers,
More informationDavid W Feigal, Jr., MD MPH
Global Harmonization Summit Where have we been with Harmonization? David W Feigal, Jr., MD MPH Adjunct Professor, College of Law, Arizona State University Partner, NDA Partners LLP September 18, 2014 Washington
More informationPharmaceutical Regulations in Japan
Pharmaceutical Regulations in Japan Tamiji Nakanishi Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare * A Japanese translation is the official
More informationMedical Devices 6 Step Guide to Global Markets:
Medical Devices 6 Step Guide to Global Markets: The BRIC Countries + Japan Intertek Cleeve Road, Leatherhead, Surrey KT22 7SB UK info.uk@intertek.com 01372 370900 www.intertek.com Contents Contents...
More informationPMDA Update: Its current situation and future direction
PMDA Update: Its current situation and future direction Tatsuya Kondo, M.D. Ph.D. Chief Executive Pharmaceuticals and Medical Devices Agency Contents 1. Organization 2. Recent Approaches for Innovative
More informationRegulatory Framework for Medical Device
Regulatory Framework for Medical Device International Seminar Safety of Health Products French Ministry of Labour, Employment and Health Paris, 26 May 2011 Peter Bischoff-Everding European Commission EU
More informationCurrent status of orphan device development in Japan
Current status of orphan device development in Japan YUKA SUZUKI, Ph.D. Director of Office of Medical Devices II, Pharmaceuticals and Medical Devices Agency (PMDA), Japan Introduction of Orphan Systems
More informationHosting Inspections from foreign countries: PMDA (Japan) ANVISA (Brazil)
Hosting Inspections from foreign countries: PMDA (Japan) ANVISA (Brazil) Kathrin Abelein Vice President Quality, R-Pharm, JSC First Russian GMP Conference 20. 22. September 2016 Agenda General information
More informationTuesday, 21 October Jang Yong Choi
Tuesday, 21 October 2014 Jang Yong Choi Contents Status of Medical Device Industry in Korea MFDS Organization and Responsibilities Medical Device Regulation Overview Medical Device Regulation Updates I.
More informationPMDA Perspective: Recent Trends in the Regulation of Biopharmaceuticals
PMDA Perspective: Recent Trends in the Regulation of Biopharmaceuticals Takao Yamori, Ph.D. Director of Center for Product Evaluation and Deputy Director General of the Office of Review Innovation PMDA,
More informationMed-Info. Introduction to Korean medical device regulations. TÜV SÜD Product Service GmbH
Med-Info International expert information for the medical device industry Introduction to Korean medical device regulations The Ministry of Food and Drug Safety (MFDS) is the healthcare agency having overall
More informationASQ Tappan Zee Section Medical Devices, New Regulations and Standards. 26 th September / V. Fischer / Rev. 01
ASQ Tappan Zee Section Medical Devices, New Regulations and Standards 26 th September / V. Fischer / Rev. 01 Agenda Medical Device, General Aspects Examples Quality System(s) New Regulations & Standards
More informationMDSAP Me M dical D e D vice S i S ngle Audit Program
MDSAP Medical Device Single Audit Program Gary Minks VP, Quality & Regulatory Affairs TÜV SÜD America Inc. gminks@tuvam.com Revision: 2013(09(29 TÜV SÜD America 13(04(29 Slide 1 IMDRF International Medical
More informationAMI MQP Market & Regulatory Analysis. Kyle Cayabyab Jameel Galloway Matt Hammond Meagan Ward
AMI MQP Market & Regulatory Analysis Kyle Cayabyab Jameel Galloway Matt Hammond Meagan Ward Overview Percentage PERCENT ARRHYTHMIA CASES THAT ARE AF 70 60 50 40 30 20 10 0 Percent Arrhythmia Cases that
More informationMed-Info. Introduction to Korean medical device regulations. TÜV SÜD Product Service GmbH
Med-Info International expert information for the medical device industry Introduction to Korean medical device regulations The Ministry of Food and Drug Safety () is the healthcare agency having overall
More informationIn the huge expanse of Asia, Singapore and
New Medical Device Regulation 16 February 2009 By Ames Gross In the huge expanse of Asia, Singapore and Hong Kong are small places. However, after Japan, they are among the most advanced medical markets
More informationGCP Convergence Improves Transportability of Medical Device Clinical Data
GCP Convergence Improves Transportability of Medical Device Clinical Data By Harmonization-by-Doing Working Group 4 The safety, performance and effectiveness of medical devices are often evaluated by well-controlled
More informationTips to Taiwan Medical Device Regulation
Tips to Taiwan Medical Device Regulation 15 th March, 2017 Rachel Tserng Qualification in Biotechnology and Business Bilingual in English and Mandarin Experience in preparation and management of regulatory
More informationUpdate on Japan s Regulation of Cell-Based Therapeutic Products
NIHS Since 1874 Stem Cell & Regenerative Medicine Global Congress 2016 August 23, 2016 Gyeonggi-do, Korea Update on Japan s Regulation of Cell-Based Therapeutic Products Yoji Sato, Ph.D. Head, Division
More information8 th Kitasato- Harvard Symposium
8 th Kitasato- Harvard Symposium CONSISTENT SAFETY RISK MANAGEMENT THROUGH THE PRODUCUT LIFE CYCLE FROM CLINICAL DEVELOPEMNT TO POST APPROVAL - Efforts of Regulatory Authority in Japan - Kaoru Misawa Director,
More informationQ and A on Application of PIC/s GMP Guide
Administrative notice February 1, 2012 To Heads of the Prefectural Health Department (Bureau) Compliance and Narcotics Division Pharmaceuticals and Food Safety Bureau Ministry of Health, Labour and Welfare
More informationApproval process for veterinary medicinal products in Japan
The JVPA forum 2016 Harumi, Tokyo, December 21, 2016 Approval process for veterinary medicinal products in Japan Evaluation and Organization Section, Planning and Coordination Division National Veterinary
More information1. GMP/Quality issues Report back from the discussion in last year s symposium
2 nd Japan - India Medical Products Regulation Symposium 1. GMP/Quality issues Report back from the discussion in last year s symposium Mr. Fumihito Takanashi, Office of International Regulatory Affairs
More informationGlobal Clinical Trials in Korea
Global Clinical Trials in Korea In-Sook Park Department of Drug Evaluation Korea Food & Drug Administration Contents Regulatory changes relevant to Clinical Trials in Korea Current Status of Clinical Trials
More informationRegulation on Clinical Trials in Japan. HBD East 2017 Think Tank Meeting
Regulation on Clinical Trials in Japan HBD East 2017 Think Tank Meeting At National Institute of Global Health and Medicine Tokyo, Japan: December 7, 2017 1 Introducing Innovative MDs Previously CT is
More informationPharmaceutical Regulations in Japan
Pharmaceutical Regulations in Japan -Generic Drug Review System, MF System- Pharmaceuticals and Medical Devices Agency (PMDA) Miho Tabata Office of Generic Drugs Pharmaceuticals and Medical Devices Agency
More informationMEDICINES CONTROL COUNCIL
MEDICINES CONTROL COUNCIL GUIDELINE FOR A LICENCE TO MANUFACTURE, IMPORT, EXPORT OR DISTRIBUTE MEDICAL DEVICES & IVDs This guideline is intended to provide recommendations to applicants wishing to submit
More informationJapan Update. IMDRF Open Stakeholder Forum September 2017
Japan Update IMDRF Open Stakeholder Forum September 2017 - Regulatory Authorities in Japan - MHLW Ministry of Health, Labor and Welfare PMDA Pharmaceuticals and Medical Devices Agency Final Authorization
More informationMedical Device Regulatory Roadmap SAMED Conference 2-3 December 2015
Medical Device Regulatory Roadmap SAMED Conference 2-3 December 2015 Dr J. Gouws Registrar of Medicines Overview Global status on MD and IVDs National status on MD and IVDs Legislation Key player and Responsibilities
More informationExposition of New Regulation in the Revision of Pharmaceutical Affairs Law For Correct Understanding of Conditional & Time Limited Approval
The contents of this presentation represent the view of this presenter only, and do not represent the views and/or policies of the PMDA Exposition of New Regulation in the Revision of Pharmaceutical Affairs
More informationKorea's Medical Device Regulatory Structure - Introduction
Korea's Medical Device Regulatory Structure - Introduction South Korea first introduced the Medical Device Act in 2003 to protect the public from unsafe devices and serve the interests of many different
More informationFOOD REGULATION ON AGROCHEMICALS FOR ENSURING QUALITY AND SAFETY OF FOOD SUPPLY IN JAPAN
FOOD REGULATION ON AGROCHEMICALS FOR ENSURING QUALITY AND SAFETY OF FOOD SUPPLY IN JAPAN Shoji Miyagawa Inspection and Safety Division, Department of Food Safety Pharmaceutical and Food Safety Bureau Ministry
More informationPMDA Update. - New Regulation in Japan and Future Direction of PMDA
PMDA Update - New Regulation in Japan and Future Direction of PMDA Kazuhiro SHIGETO, M.D., M.P.H., Ph.D. Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA) 1 Disclaimer The views and
More informationMedtech: Global Regulatory Strategy in Medical Device Product Development
Medtech: Global Regulatory Strategy in Medical Device Product Development We contribute to healthcare For Medical Device & Drug May Ng Director, Regulatory & Quality Consultant may.ng@arq-on.com Disclaimer:
More informationKorea Medical Device Regulatory Requirements Update
Korea Medical Device Regulatory Requirements Update April 28 th, 2015 Prepared by MinYong Choi UL Korea, Ltd. UL and the UL logo are trademarks of UL LLC 2015 MinYong Choi Engineering Leader Medical Regulatory
More informationIncentives and Regulatory Considerations in Orphan Drug/Medical Device Development - Situation in Japan -
Incentives and Regulatory Considerations in Orphan Drug/Medical Device Development - Situation in Japan - MHLW/PMDA, Japan Speaker: Hiroshi Takeda Reviewer, Office of New Drug III, PMDA 1 Disclaimer The
More informationSurvey on Legal Measures Mechanism on Medical Devices
Survey on Legal Measures Mechanism on Medical Devices The Working Group on Medical Measurements The 24rd Forum Meeting SIEM REAP, CAMBODIA Oct. 25-27, 2017 Hui-Ling Ting Bureau of Standards, Metrology
More informationPMDA Town Hall. Tatsuya KONDO, M.D., Ph.D. Chief Executive Pharmaceuticals and Medical Devices Agency (PMDA)
PMDA Town Hall - New Regulation in Japan and Future Direction of PMDA Tatsuya KONDO, M.D., Ph.D. Chief Executive Pharmaceuticals and Medical Devices Agency (PMDA) 1 Disclaimer The views and opinions expressed
More informationClinical Study Design for Medical Devices
Clinical Study Design for Medical Devices Greg Campbell, Ph.D. Director, Division of Biostatistics Center for Devices and Radiological Health U.S. Food and Drug Administration Kitasato-Harvard Symposium,
More informationKorea GMP & DMF. April Korea Pharmaceutical Traders Association Deputy director Oh Hyun, Kwon
Korea GMP & DMF April. 2015 Korea Pharmaceutical Traders Association Deputy director Oh Hyun, Kwon Contents 1. KPTA 2. Pharmaceutical industry 3. KGMP 4. KDMF KPTA KPTA Purpose ㅇ Trade promotion of pharmaceuticals,
More informationSection I: Pharmaceuticals and Medical Devices
SUPPLEMENT on HEALTHCARE INNOVATION Visionary Goals and Recommendations 51th Japan-U.S. Business Conference Japan-U.S. Business Council / U.S.-Japan Business Council November 14, 2014 The R&D-based pharmaceutical
More informationTrack III: International Clinical Trials: Global Compliance Norms and EU Focus
Track III: International Clinical Trials: Global Compliance Norms and EU Focus EU Focus Emmanuelle Voisin, PhD Principal, Voisin Consulting May 2008 Rationale Clinical trials in EU important part of health
More informationBasic Principles for Conducting Phase I Trials in the Japanese Population Prior to Global Clinical Trials
Administrative Notice October 27, 2014 To: Prefectural Health Department (Bureau) Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare Basic
More informationCourse Title ID Duration Basic Premium. Biological Evaluation of Medical Devices: A Risk-Based Approach N mins
Pre-Clinical Basic Level : CMDA Certified Medical Device Associate Biological Evaluation of Medical Devices: A Risk-Based Approach N134 63 mins 186.00 144.00 Introduction to Process Validation N135 75
More informationThe views and opinions expressed in the following PowerPoint slides are
Expedited Reporting of Important Changes to Foreign Safety Labeling and Expected Collaboration among Companies in Japan Rie Matsui, RPh Senior Manager, Post Marketing Regulatory Strategy, Pfizer Japan
More informationFDA Requirements for Clinical Investigations of Medical Devices: A Review for European Manufacturers
FDA Requirements for Clinical Investigations of Medical Devices: A Review for European Manufacturers Autumn Dawn Ediger, 1, * Birgit Limbach 2 and Dieter Dannhorn 3 1 Regulatory Affairs, Clinical QM and
More informationRegulatory issues for academicled multinational trials in Asia: Who takes responsibility?
CVCT Asia Workshop, 15 July 2018 Regulatory issues for academicled multinational trials in Asia: Who takes responsibility? Commentary : Kaori Shinagawa, MD, PhD Senior Scientist for Clinical Medicine Pharmaceuticals
More informationOsamu Komiyama, Kotonari, Aoki, Akira Kokan, Kiyoshi Kubota JSPE Task force for good pharmacovigilance planning in Japan November 5, 2015
Good pharmacovigilance planning in Japan: Proposals from the task force for good pharmacovigilance planning in Japan of Japanese Society for Pharmacoepidemiology (JSPE) Osamu Komiyama, Kotonari, Aoki,
More information