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

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Inter ernat national

• nal Regul

ulat ator

• ry Harmoni

nizat ation S

• n Strat

ategy egy b by MHLW LW and and PMDA A Inter ernat national

• nal 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

IMDRF has been reaffirmed as one of the most important activities.

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• 1. Establishment of new international regulatory

harmonization strategies by by M MHLW LW and and PMD MDA

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.

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• 2. Official Participation in MDSAP

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

An inno nnovative M e MD/IVD f for

• r pat

patients i in n ur urge gent need need of

• f 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 B) Pre-application substantive review

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• 3. I

Implem ement entat ation

• n of S

f Str trategy o

• f

f Saki kigake ke

C) Prioritized Review (12 months  6 months [MD]) D) Review Concierge assigned by PMDA

• 4. Clin

Clinical Innov novat ation

• n 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.

ＰＭＤＡ ＡＭＥ Ｄ Ind ndus ust ry ry

・Accelera ration

• n o
• f glob
• bal clinical

cal tr tria ials ・Dev evel elopment o

• f re

registries f for

• r

pati tients ts w with th intr tractable le dise sease ases ・Pers rson

• nnel exch

chan anges ・Post m t marketin ing s safety ty measu asures

Hospitals in ne n networks i in n Japan Hospit itals ls in A Asia Nati tional Institute te o

• f

Biom

• medical

l Innov

• vation
• n, H

Health and N Nutr triti tion

Participatio n

Data provision

Acti tivatio tion o

• f c

clin inic ical l studie ies i in J Japan by by enterprises around the world

Demographic s Therapy Complication Adverse effect Prognosis

・Research f for m meth thod t to utiliz tilize dise sease ase r regist stry i in c clinical cal s study ・Support f for R

• r R&D

&D ・Huma uman n re resourc rce culti tivati tion i in the c clinical cal r resear arch ch a and t trial al fiel eld ・Dev evel elopment o

• f d

disea ease e registr trie ies ・Accele leratio ion o

• f clin

inic ical s l studie ies

・Utilizes data in clinical studies ・Performs cost effective clinical studies

ＣＩＮ Promotion n Conf nferenc nce Nationa nal Cente ter, Clini nical Research h Core Hospital

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