Japan Update IMDRF Open Stakeholder Forum September 2017 - - PowerPoint PPT Presentation

Japan Update IMDRF Open Stakeholder Forum September 2017

- Regulatory Authorities in Japan - MHLW PMDA Ministry of Health, Labor and Welfare Pharmaceuticals and Medical Devices Agency Final Authorization of l Scientific Review for Drugs l applications & MD Publishing Guidelines GCP, GMP Inspection l l Consultation on Clinical Trials Advisory committee l l etc. Supervising PMDA Activities l 2

Medical Device Regulations in Japan Classification Class I Class II Class III Class IV General Controlled Category Specially controlled MDs MDs MDs Self- Third party MHLW approval Premarket regulation declaration certification (PMDA review) Example Post market safety PMDA and MHLW ( vigilance/surveillance) 3

R e g i s t e r e d C e r t i f i c a t i o n B o d i e s (Ninsho-Kikan) As of Sep. 2017 TÜV SÜD Japan TÜV Rheinland Japan DQS Japan BSI Group Japan SGS Japan Cosmos Corporation Japan Quality Assurance Organization(JQA) Nanotec Spindler Corporation Japan Electrical Safety & Environment Technology Laboratories(JET) Japan Association for the Advancement of Medical Equipment(JAAME) Fuji Pharma DEKRA Certification Japan Bureau Veritas Japan Intertek Japan Further information (in Japanese) http://www.pmda.go.jp/operations/shonin/info/attestation/ninsyokikan.html http://www.jaame.or.jp/jyusho/ninjyu.html

(Reference) List of Certification Standards for Third Party Certification Essential Principles Checklist with applicable standards 5

J AP AN UPDATE 1.Introduction of Conditional Early Approval Scheme 2.Introduction of SUD Reprocessing 3.Sakigake Designation 4.International Standard Approach

Conditional Early Approval for Innovative Medical Devices Accelerate approval of M Ds in high clinical needs by balancing the pre- and post-market requirements, based on the lifecycle management of the M Ds. n Present Long period Ap Review Market - Use pro Collection of clinical data val n Conditional Early Approval for Innovative MDs Partial change Ap Collection of clinical application (e.g. Market - Use Review pro expanded data val Cooperation indication, etc.) Cooperation with with Post-market academia academia Risk - Implementation of Post-market Risk Management Measures Planning Post-market Management Plan (draft) - Data collection to confirm use results, long-term performance Risk Management 7

n Reprocessers needs MAH n Reprocessed SUD needs Approval as R-SUD n Reprocessers take responsibility for R-SUD’s safety issue Single-use Medical Device (SUD) Reprocessing n Japan has introduced SUD Reprocessing from July 2017 S c h e m e f o r S U D r e p r o c e s s i n g Standard for M anufacturing and Quality control Regular inspection by PM DA (once a year) M anufacturer d i s a s s e m b l e d C l e a n i n g R e a D M anage s i s s e i m CHECK n b f l e e c , t i r o e n p a i r Secure Traceability

SAKIGAKE Designation System 9 9

(Reference) Implementation of Strategy of Sakigake An innovative M D/ IVD for patients in urgent need of innovative therapy may be designated as a Sakigake Product if; 1)its premarket application will be filed in the first in the world AND 2)prominent effectiveness can be expected. Once an M D/ IVD is designated, its developer can enjoy such benefits as: A) Prioritized Consultation by PM DA C) Prioritized Review (12 months � 6 months [M D]) B) Pre-application substantive review D) Review Concierge assigned by PM DA 10

D e s i g n a t i o n o f S a k i g a k e p r o d u c t s i n 2 0 1 6 T h e f i r s t d e s i g n a t e d m e d i c a l d e v i c e s u b m i t t e d a p p l i c a t i o n i n J u n e 2 0 1 7 I t w i l l r e v i e w e d i n p r i o r i t y r e v i e w s c h e m e a n d w i l l a p p r o v e d w i t h i n 6 m o n t h s ! No. Product name Expected performance/effectiveness Titanium Bridge M D1 Adduction-type spasmodic dysphonia (Hinge-type plate with titanium) Improvement of neurological symptoms and functional STR01 RP1 impairment due to spinal cord injury (Autologous bone marrow-derived stem cells) G47Δ RP2 Glioma (Recombinant herpes virus) Improvement of heart function in infants with congenital RP3 Autologous intracardiac stem cells heart disease

( R e f e r e n c e ) D e s i g n a t i o n o f S a k i g a k e p r o d u c t s A s o f 2 8 F e b r u a r y 2 0 1 7 , 7 m o r e p r o d u c t s ( 3 m e d i c a l d e v i c e s , 1 I V D a n d 3 r e g e n e r a t i v e m e d i c i n e s ) h a v e b e e n d e s i g n a t e d a s S a k i g a k e p r o d u c t s . No. Product name Expected performance/effectiveness Artificial tracheal Aiding reconstruction of tracheal while maintaining M D3 (made of polypropylene mesh and collagen intratracheal structure after partial removal. sponge) Glioblastoma, head and neck cancer; Selective Boron neutron capture therapy M D4 destruction of tumor cells marked by boron agents, (BNCT) system without damaging normal cells. (Neutron irradiation system for BNCT) UT-Heart Higher accuracy of prediction of effectiveness of cardiac (Software program to aid prediction of M D5 resynchronization therapy for patients with serious heart effectiveness of cardiac resynchronization failure. therapy) Cancer-related gene panel Collective examination of cancer-related genes to aid IVD1 examination system decisions on cancer treatment strategies (Diagnostic system for DNA sequencer)

No. Product name Expected performance/effectiveness Shorter re-epithelialization period after extensive CLS2702C/D RP4 endoscopic submucosa dissection (ESD) in esophageal (Oral mucosa-derived esophageal cell sheet) cancer. Dopamine neural precursor cell Novel therapy by inducing dopamine discharge to derived from non-autologous RP5 mitigate neural symptoms of patients with Parkinson’s iPS cell disease. (Therapeutic stem cell for Parkinson’s disease) Pluripotent progenitor cell derived Novel therapy for improving functional impairment form human (allogeneic) adult bone RP6 caused by acute brain infarction. marrow (Stem cell suspension derived from adult marrow)

Facilitate Development of International Standard for Evaluation method for Innovative MDs T o Enable early introduction of innovative M Ds all over the world I.Facilitate development of evaluation method (Practical, non-clinical, properly predict effectiveness and safety) II.Facilitate development of such evaluation method into International Standard Develop Standard Research Establish Evaluation methods l Support research MHLW (Grant) Committee International Standard International Regulatory, Academia, Industry Research Conference l Select project l Research l Evaluate project Evaluation l Support proposal of Standard methods l Propose ISO, IEC, Standard etc. l Support to selection of projects PMDA l Support Proposal of Standard 2017- 2018-

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