pmda updates: approach to making further...
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1Pharmaceuticals and Medical Devices Agency
PMDA Updates:Approach to Making Further Progress
Yasuhiro Kishioka, Ph.D. Principal Reviewer
Office of Cellular and Tissue-based Products Pharmaceuticals and Medical Devices Agency (PMDA)
The views and opinions expressed in this presentation are those of the presenter and should not necessarily represent the views and opinions of the PMDA.
CMC Strategy Forum Europe 2015, May 4-6, 2015, Radisson Blu Scandinavia Hotel, Copenhagen, Denmark
2Pharmaceuticals and Medical Devices Agency
Knowledge without wisdom is
a load of books on the back of an ass.(Japanese Proverb)
3Pharmaceuticals and Medical Devices Agency
Introduction Regulatory Updates in Japan Approach to Making Further Progress
Outline
4Pharmaceuticals and Medical Devices Agency
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
5Pharmaceuticals and Medical Devices Agency
3rd 5-year mid-term plan of PMDA (FY2014-2018)
Shortening the time from early development to approval improvement in consultation system, accelerated
review process, etc.
Providing high quality review/consultation services promotion of regulatory science research, etc.
Enhancing safety measures utilization of medical information database
Embracing globalization information transfer with the world
6Pharmaceuticals and Medical Devices Agency
PMDA Staff Size
0
200
400
600
800
1000
1200
2004.4 2005.4 2006.4 2007.4 2008.4 2009.4 2010.4 2011.4 2012.4 2013.4 2014.4 2018
Administrative part Safety DepartmentReview Department Planned
319256
648
521
678605
753
341
426
291
708
1065Administrative part
Review Department
Safety Department
Planned
2005 2006 2007 2008 2009 2010 2011 20122004 2013 2014 2018
7Pharmaceuticals and Medical Devices Agency
Introduction Regulatory Updates in Japan Approach to Making Further Progress
Outline
8Pharmaceuticals and Medical Devices Agency
SAKIGAKE strategy MHLW drew up a new strategy to lead the world in the
practical application of innovative medical products in 2014.
http://www.mhlw.go.jp/english/policy/health-medical/pharmaceuticals/140729-01.html
9Pharmaceuticals and Medical Devices Agency
Two Schemes for the Strategy
SAKIGAKE Designation System(Forerunner Review Assignment System)promoting R&D in Japan aiming at early practical application for innovativepharmaceutical products, medical devices, and regenerative medicines.
Scheme for Rapid Authorization of Unapproved Drugsaccelerating the practical application of unapproved/off-label use of drugsfor serious and life-threatening diseases by expanding the scope of theCouncil on Unapproved Drugs/Off-label Use to include unapproved inWestern countries if it satisfies certain conditions and by improving theenvironment for companies to undertake development of such drugs.
http://www.mhlw.go.jp/english/policy/health-medical/pharmaceuticals/140729-01.html
10Pharmaceuticals and Medical Devices Agency
(Image) Forerunner Review Assignment System
Non clinical studies, Clinical studies
Clinical trials I/II
2 m. 12 m.
Practical application of
Innovative medical products
1 m.
6 m.
③ Priority Review
② Prior-review
① Priority Consultations
④Review Partner System
⑤Strengthening Post-Marketing Safety
【Standard】
【Forerunner】
Consultation on Clinical
trialsphase III study Review
Reim-burse-ment
Post-Marke
ting
Pharmaceutical affairs
consultation for R&D strategy
Non clinical studies, Clinical studies
Clinical trials I/II
Consul-tation
on Clinical trials
phase III study
Fore-runner review assign-ment
Prior review (rolling submission) Review
Post-Marke
ting
※ In some cases, may acceptphase III data during review
Reim-burse-ment
Pharmaceutical affairs
consultation for R&D strategy
The pilot implementation will start very soon!
11Pharmaceuticals and Medical Devices Agency
Flexibility in Post-Approval changes
Standard program(Traditional approach)
Know
ledg
e
Product LifecycleApprovalApproval
Standard program(QbD approach)
?
Residual Risk
Control Strategy
Post-Approval
CMC Considerations for Accelerated Programs
Where is the acceptable Minimum Requirement?
12Pharmaceuticals and Medical Devices Agency
2005 2009 2010 2011 2012
Q&A
Somatropin BS [Sandoz]
Epoetin alfa BS [JCR]
2013
Regulatory History and Status of Biosimilars
Filgrastim BS [F], [MOCHIDA]
Filgrastim BS [NK], [TEVA]
• Application Category for biosimilars• Guideline• Nomenclature rules
Q&ARevision of Nomenclature rules
2014
Filgrastim BS [Sandoz]
Infliximab BS [NK], [CTH]
2015
Insulin glargine BS [Lilly]
13Pharmaceuticals and Medical Devices Agency
Approved IndicationsR.P. Biosimilar
Remicade Infliximab BS
Rheumatoid arthritis (incl. prevention of structural joint damage)
Crohn’s disease
Ulcerative colitis
Intractable uveoretinitis in Behcet's disease
Psoriasis vulgaris, Arthropathic psoriasis, Pustular psoriasis, Psoriatic erythroderma
Ankylosing spondylitis
Comparative study
R.P.: Reference product
Indication extrapolation of Infliximab BS
14Pharmaceuticals and Medical Devices Agency
•Crohn’s disease
Re-examination period of Infliximab
2002 Jan: Approved 2012 Jan: End of ReP
•RA
2003 Jul: Approved 2009 May: End of ReP
•RA (prevention of structural joint damage)
2009 Jul: Approved 2013 Jul: End of ReP•Behcet's disease
2007 Jan: Approved 2017 Jan: End of ReP•Psoriasis
2010 Jan: Approved 2014 Jan: End of ReP•Ankylosing spondylitis
2010 Apr: Approved 2020 Apr: End of ReP•Ulcerative colitis
2010 Jan: Approved 2012 Jan: End of ReP
•Crohn, RA, UC2013 Sep: Submission 2014 Jul: Approved
<Biosimilar (Infliximab BS)>
,ReP: Re-examination period
15Pharmaceuticals and Medical Devices Agency
Consultation for Biosimilars
Fiscal year
No.
of c
onsu
ltatio
ns
2006 2007 2008 2009 2010 2011 2012 20130
5
10
15
20
25
Based on date of application
(from April 1 to March 31)
2014
<Number> <Product type>
(65%)mAbs & Fc-fusion proteins
16Pharmaceuticals and Medical Devices Agency
Introduction Regulatory Updates in Japan Approach to Making Further Progress
Outline
17Pharmaceuticals and Medical Devices Agency
Key Enablers
International Cooperation
Communication with Industries
18Pharmaceuticals and Medical Devices Agency
ICH PDG IMDRF IGDRP ICCR
ICH: International Conference on Harmonisation PDG: Pharmacopeial Discussion Group IMDRF: International Medical Device Regulators Forum IGDRP: International Generic Drug Regulators PilotICCR: International Cooperation on Cosmetics Regulation APEC LSIF RHSC : APEC Life Science Innovation Forum RegulatoryHarmonization Steering Committee
OECD MAD : OECD Mutual Acceptance of DataHBD: Harmonization By Doing
ICMRA
ICDRA
ICDRA: International Conference of Drug Regulatory Authorities ICMRA: International Coalition of Medicines Regulatory Authorities
HBDAPEC LSIF RHSCChina-Korea-
Japan Tripartite
OECD MAD
Current International Activities
19Pharmaceuticals and Medical Devices Agency
PMDA’s Contributions in the Asia/WorldAt the Nov. 2014 Summit of Heads of Medicines Regulatory Agencies, enhancement of collaboration among Japan/China/Korea was affirmed.
Confidentiality arrangements* Staff posting Joint
symposium
* Confidentiality arrangements: Arrangements to exchange confidential regulatory information retained by each country
Singapore
Thailand
ChinaFrance
Switzerland
Netherlands
U.K.
Ireland
Japan
Taiwan
Indonesia
Australia
U.S.A.
Brazil
Canada.
EU
Italy
Scheduled to take the office of Vice Chair of the OECD Working Group on GLP in 2015.
Korea
20Pharmaceuticals and Medical Devices Agency
Training for Foreign Regulatory Officers
Pharmaceuticals:1st (Nov. 2010) New Drugs Review2nd (Dec. 2011) GMP inspection3rd (Jan. 2013) Post-Marketing Safety & Relief Services4th (Feb. 2014) Generic Drugs Review5th (Oct. 2014) New Drugs ReviewMedical Devices:1st (Mar. 2014) Medical Device Regulation2nd (Feb. 2015) Medical Device Regulation
NADFC (Indonesia) officials: 5 days, 2013 FDA (US) analyst: 6 months, 2014 NPBC (Malaysia) officials: 1 month, 2014 Thai FDA (Thailand) officials: 5 days, 2014 2014 etc.
Individual Training (including OJT)
PMDA Training Seminar
21Pharmaceuticals and Medical Devices Agency
Key Enablers
International Cooperation
Communication with Industries
22Pharmaceuticals and Medical Devices Agency
Many Channels with Industries Regular Meetings for Exchange of Opinions
WG for Review
WG for Consultation
WG for MRCT WG
for Audit
SWG
SWG SWG
Work Request
Progress Report
PMDA
Integrated Project Team
•MRCT project•….•QbD assessment project•Post-Approval Mfg. Changes project
Integrated Project Team in PMDAhttp://www.pmda.go.jp/english/rs-sb-std/standards-development/cross-sectional-project/0003.html
23Pharmaceuticals and Medical Devices Agency
MHLW Sponsored Science Research
(Example) Outputs (in English)
QOS (2.3.P) mockhttp://www.nihs.go.jp/drug/section3/English%20Mock%20QOS%20P2%20R.pdf
Application Form mockhttp://www.nihs.go.jp/drug/section3/English%20mock%20App.pdf
QOS (2.3.S) mockhttp://www.nihs.go.jp/drug/section3/H23SakuramillMock(Eng).pdf
CTD 2.3.P.2 mockhttp://www.nihs.go.jp/drug/section3/QbD_P2_mock_SakuraBloomTab_E_Feb2015.pdf
(Research on Regulatory Science of Pharmaceuticals and Medical Devices)
ICH Training Material for ICH Q8, 9, 10
Academia
Industries PMDA
Implementation of QbD Approach and Description in QOS and Application Form
Real Time Release Testing Design Space Analytical QbD …Etc.
24Pharmaceuticals and Medical Devices Agency
Knowledge without wisdom is
a load of books on the back of an ass.(Japanese Proverb)
25Pharmaceuticals and Medical Devices Agency
Thank you for your attention!
kishioka-yasuhiro@pmda.go.jpPharmaceuticals and Medical Devices AgencyOffice of Cellular and Tissue-based Products
Yasuhiro Kishioka, PhD.
Acknowledgements• Colleagues in the Office of Cellular and Tissue-based Products• Colleagues in the Office of International Programs
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