Japan Update - New measures to improve access to innovative - PowerPoint PPT Presentation

Japan Update - New measures to improve access to innovative MDs/IVDs - September, 2015

Topics 1. New international regulatory harmonization strategies by MHLW and PMDA 2. Official participation in MDSAP Pilot 3. Implementation of Strategy of Sakigake 4. Clinical Innovation Network 2

1. Establishment of new international regulatory harmonization strategies by by M MHLW LW and and PMD MDA Inter ernat national onal Regul ulat ator ory Harmoni nizat ation S on Strat ategy egy b by MHLW LW and and PMDA A Inter ernat national onal Strat ategi egic P Plan 2015 2015 by by P PMDA have been published on 26 June 2015. Based on the mutual ually c compl plem ement entar ary strategies, the following measures will be taken: A) Promotion of Regulatory Science Guidelines related to medical device regulations in Japan will be prepared and internationally announced. B) Establishment of Training Center for regulatory matters PMDA will provide regulators outside Japan with training for capacity building. C) Active commitment to IMDRF as well as advancement of bilateral collaboration 3 IMDRF has been reaffirmed as one of the most important activities.

2. Official Participation in MDSAP Japan made an announcement on the offic icia ial p partic icip ipatio ion in MDS DSAP P Pilo ilot on 23 June 2015. Further information will be provided in a timely manner. Shown at right is the press release on the official participation in MDSAP Pilot in Japan (written in Japanese). You can find the announcement in English here; http://www.fda.gov/MedicalDevice s/InternationalPrograms/MDSAPP ilot/ucm452243.htm 4

3. I Implem ement entat ation on of S f Str trategy o of f Saki kigake ke An inno nnovative M e MD/IVD f for or pat patients i in n ur urge gent need need of of inno nnovative ther erapy apy may be designated as a Sakigake Product if; 1) its premarket application will be filed in Japan firstly or simultaneously in some countries including Japan, AND ND 2) prominent effectiveness can be expected. Once an MD/IVD is designated, its developer can enjoy such benefits as: A) Prioritized Consultation by PMDA C) Prioritized Review (12 months  6 months [MD]) B) Pre-application substantive review D) Review Concierge assigned by PMDA 5

4. Clin Clinical Innov novat ation on Ne Network ( (CI CIN) N) The clin linic ical study dy i infras astruc uctur ure in Japan will be improved under the CIN project so that cost effective clinical studies can be performed with h diseas ease r e registries es , based on Regulatory Science. The improvement will accelerate clinical studies in Japan by enterprises around the world, which would results in the contribution to extended healthy life expectancy for people. Nationa nal Cente ter, Acti Nati tional Institute te o of Ind ndus ust Biom omedical l Innov ovation on, H Health by by enterprises around the world tivatio Clini nical Research h Core ry ry and N Nutr triti tion Participatio Hospitals in ne n networks i in n Japan Hospital tion o n Demographic s Therapy Hospit itals ls in A Asia of c Complication Adverse effect Data ・ Utilizes data in clin Prognosis ・ Accelera ration on o of glob obal clinical cal clinical studies provision inic ・ Dev evel elopment o of d disea ease e ・ Performs cost tr tria ials ical registr trie ies effective clinical ・ Dev evel elopment o of re registries f for or studies l studie ・ Accele leratio ion o of clin inic ical s l studie ies ・ Support f for R or R&D &D pati tients ts w with th intr tractable le ・ Pers rson onnel exch chan anges ・ Huma uman n re resourc rce culti tivati tion i in dise sease ases ・ Post m t marketin ing s safety ty ies i the c clinical cal r resear arch ch a and t trial al measu asures fiel eld in J ＰＭＤＡ ・ Research f for m meth thod t to utiliz tilize ＡＭＥ Japan dise sease ase r regist stry i in c clinical cal s study Ｄ 6 ＣＩＮ Promotion n Conf nferenc nce

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