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

ThaiFDA

ThaiFDA-3 Sep. 2015

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

ThaiFDA

ThaiFDA-3 Sep. 2015

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

ThaiFDA

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

ThaiFDA

ThaiFDA

ThaiFDA-3 Sep. 2015

Regional and global cooperation

Border cooperation

Bilateral cooperation

International strategy of ThaiFDA

ThaiFDA

ThaiFDA-3 Sep. 2015

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)

ThaiFDAThaiFDA

ThaiFDA

ThaiFDA

ThaiFDA

ThaiFDA

ThaiFDA-3 Sep. 2015

ASEAN = Association of Southeast Asian Nations

Established = 8 Aug. 1967

Size ~ 4.5 mil.Km2

ASEAN population ~ 600 million

ThaiFDA

ThaiFDA-3 Sep. 2015

Old members = ASEAN 6

New members= CLMV

The ASEAN Member State

ThaiFDA

ThaiFDA-3 Sep. 2015

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 !

ThaiFDA

ThaiFDA-3 Sep. 2015

ASEAN’s International Cooperation

Thailand coop. with Japan, thru ASEAN !

ThaiFDA

ThaiFDA-3 Sep. 2015

Japan & Thailand joining “Nov. 1989”

ThaiFDA

ThaiFDA-3 Sep. 2015

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”

ThaiFDA

ThaiFDA-3 Sep. 2015

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

ThaiFDA

ThaiFDA-3 Sep. 2015

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

ThaiFDA

ThaiFDA-3 Sep. 2015

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

ThaiFDA

ThaiFDA-3 Sep. 2015

ThaiFDA and MHLW/PMDA Cooperation

ThaiFDA

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

ThaiFDA

ThaiFDA-3 Sep. 2015

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)

ThaiFDA

ThaiFDA-3 Sep. 2015

Expectations

towards

MHLW/PMDA International Strategic Plan

ThaiFDA

ThaiFDA-3 Sep. 2015

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 !

ThaiFDA

ThaiFDA-3 Sep. 2015

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

ThaiFDA

ThaiFDA-3 Sep. 2015

Ceremony-Signed Memorandum of Understanding

“8 Organization”

To Build & Strengthening Knowledge/Competency on

Regulatory Sciences of Thailand

ThaiFDA

ThaiFDA-3 Sep. 2015

Ceremony-Signed Memorandum of Understanding

ThaiFDA

ThaiFDA-3 Sep. 2015

Dr.Takashi MISUOffice of Safety II, PMDA

ThaiFDA

ThaiFDA-3 Sep. 2015

Thank You !!!ありがとうございます / Khob Khun Krub !