khdi korea pharma industry in the era of globalization
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7/31/2019 KHDI Korea Pharma Industry in the Era of Globalization
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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
7/31/2019 KHDI Korea Pharma Industry in the Era of Globalization
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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?
7/31/2019 KHDI Korea Pharma Industry in the Era of Globalization
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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.