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K orean Pharm ac eut i c a l Indust ryK orean Pharm ac eut i c a l Indust ry

Kyung Won Jang, Ph.D.

Director General

Department of Global Healthcare Business

In t he era o f Global izat ionIn t he era o f Global izat ion

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“ One of the most impressive reforms for the financial sector” 

- C. Noyer (Bank of France Governor) - 

Korea chaired and hosted the G20

Pursue market-determined exchange rate systems…Reduce their excessive current account surpluses…

Work together to promote global sustainable growth

- Joint Statement of G20 Korea -

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Work Together with Korean Companies for Sustainable Growth

Competitiveness of Korean Companies

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How do we manage the challenges facing pharma?

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Excellent R&D Base with Highly Educated Workforce

FastGrowing

DevelopedMarket

HighQuality

E x  p a n d a b i l i t  y   G o v e r n m

 e n t a l 

 S u p p o r t

KoreanPharmaceutical

Industry

Easy to Expandto Emerging

Markets

“Collaboration friendly”Governmental Support

High Quality

ClinicalInvestigators &

Regulatory

Authority

One of the Most

Developed

Asian PharmaceuticalMarkets

Fast Growing

Pharmaceutical Industry

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Strong Collaboration among Academia-Government-Industry

Delivery of the value of innovation

R&D Capability

Capacity and enthusiasm for R&D

Promotion of excellent outcomes

Introduction of policy & investment

Delivery of support to R&D

PharmaIndust ry

GovernmentGovernment

IndustryIndustry

R&DR&D

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2005 (total 115773) 2006 (total 119085) 2007 (total 115975) 2008 (total 142597) 2009 (total 96497)

1 New York 1140New York 969Houston 1266Houston 1165Houston 934

2 Boston 1124Houston 910New York 1232New York 1164New York 792

3 Houston 955Boston 849Boston 975Boston 966Boston 758

4 Chicago 870Chicago 826Berlin 919Berlin 864Seoul 696

5 Philadelphia 838Philadelphia 763Chicago 796Philadelphia 858Berlin 594

6 Los Angeles 799Baltimore 760Philadelphia 726Chicago 791Philadelphia 572

7 Toronto 748London 725Los Angeles 660Los Angeles 789Chicago 5728 Atlanta 744Dallas 648Dallas 637Dallas 747San Antonio 549

9 Seattle 732Los Angeles 641London 631San Antonio 747Baltimore 538

10 London 705Toronto 626San Antonio 591London 723London 532

11 Baltimore 688Berlin 617Baltimore 581Seoul 696Paris 525

12 Dallas 637Atlanta 607Rochester 580Baltimore 694Los Angeles 510

13 Portland 619Cleveland 580Cleveland 570Paris 684Dallas 508

14 Paris 611Birmingham 573Toronto 555Toronto 675Toronto 475

15 Pittsburgh 597San Antonio 548Madrid 528Atlanta 652Cleveland 446

16 Rochester 589Madrid 543Moscow 528Birmingham 623Rochester 44417 Berlin 571Rochester 538Seoul 527San Diego 604Nashville 443

18 San Antonio 558Moscow 534Columbus 522Portland 599Portland 431

19 Cleveland 549Seattle 532Atlanta 521Moscow 592San Diego 429

20 San Diego 546Portland 510Seattle 518Cleveland 587Atlanta 427

21 Birmingham 539Barcelona 508Paris 503Madrid 575Seattle 415

22 Denver 523Pittsburgh 506Barcelona 497Columbus 561Madrid 413

23 Cincinnati 516Columbus 500Nashville 473Seattle 554Birmingham 403

24 St. Louis 499Paris 477Birmingham 467Cincinnati 549Cincinnati 391

25 Montreal 497 Indianapolis 476Portland 466Nashville 544Columbus 38526 Indianapolis 492Montreal 466Pittsburgh 461Rochester 521Barcelona 378

27 Taipei 472Cincinnati 462Cincinnati 433Barcelona 521Moscow 359

28 Columbus 452Miami 455Miami 429Miami 517Miami 357

29 Kansas City 442San Diego 453San Diego 423 Indianapolis 511St. Louis 345

30 Miami 439St. Louis 426 Indianapolis 419Pittsburgh 499Pittsburgh 324

77th - Seoul 21837th - Seoul 376

City Ranking by the No. of Clinical Trials Registered each year in ‘US NIH’ 

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Internal Discovery Efforts

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중앙제약(JungAng Pharm.)

(Yuhan Corp.)

(Dong-A Pharm.)

Joint

Venture(>10)

Product

License(>50)

Tech

License

(>20)

(Daewoong Pharm.)

(Hanmi Pharm.)

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KORUS FTA on Pharmaceutical

Promoting the development of and facilitating access tohigh-quality products

Recognizing the importance of appropriate government support of

research & development

Ensuring the rules and procedures are fair, reasonable, and non-discriminatory

KORUS FTAKORUS FTA ImplementationImplementation

Formation of Medicines and Medical Devices Committee

Discussing conformity on assessment for GMP, GLP andmarketing approval of generic drugs

KORUS FTA is the first to include a separate chapter on thea separate chapter on the

pharmaceutical and medical devicespharmaceutical and medical devices

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Expanding into the greater part of Asia

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Full-scale execution of the Medical-Cluster projectEnforcement of the ‘Special Act on the Designation and Support of a Cutting-EdgeMedical Complex’ (Jun 28, 2008)

Full-scale execution of the Medical-Cluster projectEnforcement of the ‘Special Act on the Designation and Support of a Cutting-EdgeMedical Complex’ (Jun 28, 2008)

New Drug Development support Center

→ Candidates evaluation and joint development ofcandidates

Medical Device Development support Center:

→ Product design, prototype production,performance evaluation, and joint research

Clinical Trial Center

→ Minimum small-scale clinical test of prototypecandidates

FacilityFacility

ProcessProcess

Facilitate the revitalization and commercialization of the medical R&D through thecooperation among hospitals, companies, universities, and research centers.

Facilitate the revitalization and commercialization of the medical R&D through thecooperation among hospitals, companies, universities, and research centers.

Core Research InfrastructureCore Research Infrastructure

Bio resource center:→ Cells for research use and specimen storage

New drug for Clinical Trial ManufacturingCenter→ A center for production of new drugs for

clinical test use

Laboratory animal center

→ Raising and management of laboratoryanimals

Research Support FacilitiesResearch Support Facilities

Purpose

Purpose

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11 Raises experts

• Raises experts on medicine GoodManufacturing Practice (GMP).

2 2  Provides statistics

• Establishes and operates drug statisticsanalysis systems.

3 3  Supports R&D

• The innovative drug development supportproject

• The super generic cultivation project• Expands the bio medicine technology

development project.• Establishes clinical test infrastructure.

44 Supports export

• Runs the drug export support center.• Supports import/export of medicine and bio

technology.• Establishes an information bank on foreign

medicinepermission and the export/import of medicine.

• Supports the participation of overseas drug

expos.• Dispatch teams for entering into overseas

pharmaceutical markets.• Supports the acquirement of overseas drug

permission.

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Now is the best time

to form Korea-US partnership

on pharmaceutical business.

Thank you.