ThaiFDA - 医薬品医療機器総合機構ThaiFDA ThaiFDA-3 Sep. 2015 Celebrating MHLW/PMDA New...
Transcript of ThaiFDA - 医薬品医療機器総合機構ThaiFDA ThaiFDA-3 Sep. 2015 Celebrating MHLW/PMDA New...
ThaiFDA
ThaiFDA-3 Sep. 2015
ThaiFDA
ThaiFDA-3 Sep. 2015
Celebrating MHLW/PMDA
New International Strategic Plans
Boonchai SOMBOONSOOK, M.D., M.T.H.
Secretary-GeneralFood and Drug Administration (ThaiFDA)
Ministry of Public Health, THAILAND
Nissho Hall, Tokyo, JAPAN
September 3, 2015
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Demographics and Healthcare Market in
Thailand
ThaiFDA: Strategy and Challenges
ThaiFDA and MHLW/PMDA Cooperation
Expectations towards MHLW/PMDA’s New
International Strategic Plan
Presentation Outline
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Demographics and Healthcare Market
in Thailand
Percentage Distribution of Population (2015)
17.7
66.5
15.812.9
54.1
33.1
0
10
20
30
40
50
60
70
0-14 15-59 over 60
%
Year
Thailand Japan
Source: Nations Department of Economic and Social Affairs/Population Division World Population Prospects: The 2015 Revision, Key Findings and Advance Table
Thailand Japan
Total Population (2015) a 67.96 million 126.57 million
Male 33.50 m. 61.56 m.
Female 34.47 m. 65.02 m.
GDP (USD) 2014b 0.373 Trillion 4.6 Trillion
GDP per capita (USD) 2014b 5,560 36,194
Total health expenditures (USD)
(% of GDP) 2013c
18 Billion
(4.6%)
505 Billion
(10.3%)
Health expenditures per capita (USD) c 264 3,966
Healthy life expectancy at birth (2013) 66 years 75 years
Life expectancy at birth (both sexes) in 2013 75 years 84 years
a. United Nations Department of Economic and Social Affairs/Population Division World Population Prospects: The 2015
Revision, Key Findings and Advance Table
b. Worldbank data
c. World Health Organization. Global Health Expenditure Databased. World Health Organization . Global Health Observatory Data Repository
Demographics and Health Statistics
Pharmaceutical products
Year Estimated ValueMillions (USD)
Import from Japan
to Thailand a2013 381
2012 350
2011 306
Export from
Thailand to Japan b2014 13.65
2013 14.80
2012 21.0
Source: a. Bureau of Drug Control, ThaiFDA
b.United Nations Commodity Trade Statistics Databasec- Medical Devices Control Division, ThaiFDA
Import and Export Values of Pharmaceuticals/ Medical Devices
Medical Devices Year Estimated ValueBillions (USD)
Import from Japan to
Thailand c2014 1.57
2013 1.63
2012 1.52
Export from
Thailand to Japan c2014 2.92
2013 2.56
2012 2.67
ImportExport
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ThaiFDA-3 Sep. 2015
ThaiFDA: Strategy and Challenges
ThaiFDA
ThaiFDA-3 Sep. 2015
Cluster Medical Services Development
Cluster Public Health Services Support
Cluster Public Health Development
• Dept. of Medical Services
• Dept. of Mental Health
• Dept. of Thai Traditional and
Complementary Medicine
• Dept. of Medical Sciences
• Dept. of Health Services
Support
• Food and Drug Administration
(ThaiFDA)
• Dept. of Disease Control
• Dept. of Health
Ministry of Public Health
Secretary-General
Deputy SG(3)
Bureau of Import/Export
Control
Medical DevicesControl Division
Bureau of Food
Bureau of Drug Control
Narcotic Control Division
Cosmetic andHazardous Substances
Control Bureau
Information Technology Center
Legal AffairGroup
Internal Audit Task Group
One Stop Service Center(OSSC)
Complaint & Suppression Center
Technical and PlanningDivision
Public & Consumer Affairs DivisionOffice of the Secretary
Rural and Local Consumer Health
Promotion Division
Committees/Sub-comm.
Senior Advisors(2) /Senior Experts
Public SectorDevelopment Group
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Regional and global cooperation
Border cooperation
Bilateral cooperation
International strategy of ThaiFDA
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Scope - Technical, Guideline, ProcedureCoverage - NCEs, Generic, Herbal med.,..Topic - GMP Inspection, Drug Evaluation,
PQP-Vaccine , DCVRN, etc…
WHO(>190 countries)
RHSC(APEC-LSIF)
ICH(EU+Japan+USA)
ThaiFDA - International Activities
on Regulatory Harmonization, Convergence & Coop.
PANDRH(Pan American)
SADC(South Africa)
GCC(Middle East)
BIMST-EC(South Asia)
PWGs /AWGPD(ASEAN)
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ASEAN = Association of Southeast Asian Nations
Established = 8 Aug. 1967
Size ~ 4.5 mil.Km2
ASEAN population ~ 600 million
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Old members = ASEAN 6
New members= CLMV
The ASEAN Member State
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The ASEAN- Cooperation
ASEAN Summit
Economic Cooperation (AEC) - Political & Security Cooperation (APSC)
- Socio-cultural Cooperation (ASCC)
WG1 - Mutual Recognition Arrangements (MRAs) & Standards
WG2 - Accreditation and Conformity Assessment
WG3 - Scientific/Industrial Metrology
AEM
SEOMACCSQ
ACC - ASEAN Committee on Cosmetic
PPWG - Pharmaceuticals PWG
Pf PWG - Prepared Foodstuff PWG
TMHS PWG - Traditional Medicine & Health Supplement PWG
Medical Devices&Equipment PWG
AWGPD – ASEAN Working Gr. on Pharmaceuticals Dev.
AHMM
ASCC Council
ASODSOMHD
EE PWG- Electrical and Electronic PWG
A PWG - Automotives PWG
RB PWG - Rubber-based PWG
…….
ASEAN Sectoral Working on Traditional Medicine
Initiatives on Traditional Medicine
ThaiFDA proactive role in ASEAN
ThaiFDA continue Proactive on POST 2015 Activities !
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ASEAN’s International Cooperation
Thailand coop. with Japan, thru ASEAN !
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Japan & Thailand joining “Nov. 1989”
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The APEC-LSIF/ RHSCAIM: Capacity Building /Strengthening & Regulatory Convergence
Through “Roadmap”
1. Roadmap on Medicinal product/Vaccine
1) Multi Regional Clinical Trail (MRCT) (Japan)
2) Promoting Regulatory Capacity and Convergence in the Assessment
of Good Clinical Practice Standards Applied to Clinical Trails
(GCP Inspection) (Thailand)3) Promote Harmonization & Convergence of Regulatory Pathways for
Biotherapeutic Products
4) Advanced Therapies (Cell and Tissue Therapy)
5) MRCT Center of Excellence
2. Roadmap on Medicinal product/Vaccine & Medical Devices
1) Good Review Practices on Medical Products (GRevP)
2) Promote Regulatory Convergence of Combination Product
3. Roadmap for Overall Regulatory
1) Global Medical Product Integrity and Supply Chain Security
2) Promote Regulatory Convergence for Pharmacovigilance(PV)
MHLW/PMDA & ThaiFDA active Members of RHSC
NOW together on “coRMs-MRCT & GCP Inspection”
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PMDA
o Annual Symposium- 2013 onwards
o Study Visit
o Strengthening Support :- Internal Reviewer, Consultative system, Abridged
Registration, Pharmacopoeia
o Joint/Co Roadmaps under APEC-LSIF/RHSC “MRCT & GCP Inspection”
China
o MOC: - SFDA and MOPH, since 2007/ now is renewing !
o Annual Executive Meeting
o Technical Training Seminar/Workshop
Bhutan: developing, on Capacity Building and Quality System)
Border Neighbor Countries : Cambodia, LaoPDR, Malaysia, Myanmar
o Border Trade
o Import & Export Monitoring System
o Capacity Building & Strengthening
Bilateral Cooperation : ThaiFDA
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Increasing WORKLOADS under the Gov. downsizing policy
High expectation on SPEED /DEREGULATION from Government
&Industry
e.g., Licensing Facilitation Act, B.E. 2558 (2015)
Lack of EXPERTISE both In-house & External
AEC framework – from Harmonization MRA
A NEED from International Strategy towards COLLABORATION
with Neighboring NRA (CLM & M)
Challenges of ThaiFDA
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Workload of Dossier Submission
Category 2012 2013 2014
Overall No. of dossier
submission
1,522 1,993 1,673
New Drug 175 169 138
Biologics
New Biologics
Vaccines
Others
64
22
10
32
90
40
5
45
39
30
2
7
Generic Drug 337 522 533
Traditional/Herbal Drug 763 1061 853
Veterinary Drug 183 151 110
Variation submission 5,818 5,971 3,247
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ThaiFDA and MHLW/PMDA Cooperation
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ThaiFDA-3 Sep. 2015
Global: Regulatory Harmonization, Convergence & Coop.
Scope - Technical, Guideline, ProcedureCoverage - NCEs, Generic, Herbal med.,..Topic - GMP Inspection, Drug Evaluation,
PQP-Vaccine , DCVRN, etc…
WHO(>190 countries)
RHSC(APEC-LSIF)
ICH(EU+Japan+USA)
MHLW/PMDA
MHLW/PMDA
MHLW/PMDA
MHLW/PMDA the World std. & Global recognized DRA
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Appreciate continuing CLOSE COOPERATION
• Annual Symposium
• Joint Programs
• Capacity Building
Need to UNDERSTAND & LEARN from MHLW/PMDA
• Japanese Pharmacopoeia (JP)
• Pre-marketing Consultative System
• Regulatory Science: TOOLS & TECHNIQUES
• As a MODEL for ThaiFDA & NIPA
MHLW/PMDA & ThaiFDA
Note: NIPA =National Institute of Health Products Assessment and Inspection)
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Expectations
towards
MHLW/PMDA International Strategic Plan
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Appreciate & Support
Establishing “Regulatory Science Center”
o Will make Regulatory Science” well-known
o Benefit “Japan”, and “other Countries”
Launching “Asian Training Center for P’cal & Med.Devices
Regulatory Affairs”
o BIG HELP to ASEAN member states
o In FILLING a GAP of “Developing Regulatory Capability” &
“Scientific Excellence”
o BENEFIT to both Regulatory Authority and Industry
Expectation Full Assessment Rpt. of NMEs in English, Abridged Registration !
Collaboration in “Dossier Review”, Innovative Products!
MHLW/PMDA International Strategic Plan : Expectation !
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Relevant Mission & Plan of ThaiFDA
• To Build “In-house Expertise”
• To Develop :o Personnel Exchange Program with Foreign Regulatory
Authorities
o System of Abridged Registration for prioritized products
• To establish “Consultative System”
• To develop “MRA” with ASEAN Member State
MHLW/PMDA’s New International Strategic Plan & Close Coop.
a Great Part of Friendship & SUCCESS !!!
ThaiFDA & MHLW/PMDA : The Final Perspective
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Ceremony-Signed Memorandum of Understanding
“8 Organization”
To Build & Strengthening Knowledge/Competency on
Regulatory Sciences of Thailand
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Ceremony-Signed Memorandum of Understanding
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Dr.Takashi MISUOffice of Safety II, PMDA
ThaiFDA
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Thank You !!!ありがとうございます / Khob Khun Krub !