Transcript A New Paradigm for Medical Products Regulation in Taiwan 2010.09.10

A New Paradigm for Medical
Products Regulation in Taiwan
Taiwan Food and Drug Administration
2010.09.10
1
TFDA Organization Chart
2
2
Pharmaceuticals Regulation in Taiwan
Pre-Market Approval
Research &
Discovery
Preclinical
Testing
IND/IDE
NDA/
PMA
Market
GPvP
GLP
IRB/GCP
ADR/AE
Reporting
Quality
ADR/AE ★
Reporting
Insurance
GTP
cGMP
★ADR/AE: adverse drug reaction/adverse event
3
Post-Market
Management
3
Drug
Injury
Relief
Milestones on Drug Regulation
1980
1990
1982
GMP
2000
2010
PIC/S GMP
1999
cGMP
1993
Local
clinical trial
2010
2000
2001
Bridging Study Pivotal trial/
Evaluation early phase trial
in accordance with
ICH E5
1998
CDE
4
2001
TDRF
2010
TFDA
Establishment of TFDA and
Reform of Drug Review System
 Enhancing quality, efficiency, and
transparency in reviewing of pharmaceuticals
and medical devices
 Fostering the development of
biopharmaceutical industry
 Promoting international harmonization on
drug regulation
5
Transparency and Quality Assurance
 Review quality assurance: QA/QC task force
(2010.03)
 On-line Roadmap : for tracking review
progress for sponsor (2010.05)
 Implementation of Good Review Practice
(GRP) (2010.07)
 Disclosure of assessment report for NCE
(2010.08)
6
NDA/PMA Review Process
Sponsor Application
TFDA Review Team
(TFDA Staff+ CDE)
Global New,
Botanical product,
Biosimilar product,
etc.
Technical and
administrative document,
GMP/PMF
Assessment report
Consult with AC experts for
special concern
Advisory
Committee
Decision
7
7
Sponsor
Establishment of modern Clinical Trial
Environment in Taiwan
 Preclinical GLP inspection
 Meet international standard
 GCP inspection
 Follow ICH –E6 GCP
 Enhancement of the quality of IRB
 international: SIDCER or FERCAP certified IRB
 domestic : DOH audited 38 IRB
 Training for clinical trial professional
 Investigators, clinical research coordinators (CRC), clinical research
associates (CRA), study nurses etc.
 Improvement of clinical trial Infrastructure
8
8
Improvement of
Clinical Trial Infrastructure
Government funded Research Centers
Grant $22 million (NT) in 2010
General Clinical Research Center (GCRC): 11 sites
Center of Excellence: 5 sites
Center of Excellence for Cancer Research: 8 sites
Site Management Organization (SMO)
Qualified sites for IND/IDE: 128 teaching hospitals
9
9
MOU ★ between Taiwan Center of Excellence
and International Pharmaceutical Company
MOU assigning date Taiwan-international pharmaceutical company
10
2007-09-30
National Taiwan University-GSK
2009-03-25
National Taiwan University-Novartis
2009-07-16
National Taiwan University-Boehringer
Ingelheim
2009-11-30
National Taiwan University-Pfizer
2010-05-13
Taipei Veterans General Hospital-GSK
2010-08-31
Chung Gung Medical Hospital-Novartis
2010-09-01
China Medical University Hospital -Novartis
★MOU: Memorandum of Understanding
Taiwan Global Trials Sponsored by
International Companies
11
Ranking
International Company
Case number (phase I-III)
1
A
49
2
B
35
3
C
31
4
D
26
5
E
26
6
F
21
7
G
21
8
H
19
9
I
19
10
J
17
11
Roche
15
12
L
15
source: 2007~2010 Q2, CDE database
Clinical trials conducted in Asia
as of July 12, 2010
East Asia
Southeast Asia
Taiwan
1792
India
1331
Singapore
692
Japan
1523
Pakistan
150
Thailand
717
Korea Republic of
1907
Bangladesh
76
Philippines
393
China
1664
Nepal
13
Malaysia
326
HongKong
519
Sri Lanka
14
Indonesia
116
Korea, Democratic
People’s Republic of
0
Afghanistan
7
Cambodia
15
Vietnam
70
Myanmar
4
Total
12
South Asia
7,405
Total
1,591 Total
2,333
Source: http://www.clinicaltrials.gov
12
Clinical Trial Environment
in Excellent Centers
Country
Taiwan
Korea
China
Population
22.9 M
48 M
1300 M
Cost



Approval of
Protocol



2~3 Months
8~12 Months
Data Quality
(US trained)





Medical staff



Patient retention



Investigator
1~1.5 Months
source: TrialTrove, May 2009
13
International Cooperation
 Memorandum of Understanding with Australia
 EOLs ★ : GMP inspection & AE information sharing with USA, EU,
and Switzerland
 TCP ★ ISO 13485 audit report sharing with 12 EU Notified Bodies
 Application of PIC/S membership
 APEC (LSIF, ISTWG), ICH-GCG and etc.
 Future works:
 Promote collaboration with Japan, China and Korea, Singapore and
Thailand
 Participate WHO and related organization or meetings, such as ICDRAs ★
14
★EOLs: exchange of letters
★ ICDRAs: International Conference of Drug Regulatory Authorities
14
★TCP:Technical Cooperation Program
Cross-Strait Cooperation in Clinical Trial
ECFA , Signed Between China and Taiwan
(2010.06), opens a favorable cross-strait
interaction mechanism and will improve the
basis of promoting Taiwan’s cooperation with
other countries
Cross-Strait cooperation on new drug
research and clinical trial (in progress)
★
★ECFA: Economic Cooperation Framework Agreement
15
Major Breakthroughs (I)
Relaxation of CPP
Non-CPP
1-CPP
2-CPP
Expected review time
720 days ( 2 years):
360days plus GXP inspection 360days
Expected review time
300 days
Expected review time
200 days
1. Early phase
clinical trials
in Taiwan
2. REMS/RMP
1. pivotal clinical trial
in Taiwan
1. REMS/RMP if necessary
2. REMS/RMP if necessary
★CPP: Certificate for Pharmaceutical Product from 10 advanced countries
★REMS/RMP: Risk Evaluation and Mitigation 16Strategy/ Risk management plan
16
★ GXP: GCP,GLP,GMP
16
Major Breakthroughs (II)
New Review Tracks
Priority Review
(unmet
medical needs)
Expected review
time：180 days
Priority review:
Full documents
Abbreviated
Review
(FDA + EMA
approved)
Accelerated
Review
(For new agents
with high
industrial value)
Expected review
time:150 days
Expected review
time：180 days
Partial review,
focused on
bridging data,
REMS, PSUR, etc.
Accelerated
Review:
Full documents
17
17
Verification Review
(Future with MOU)
Verification
based on
reference
agencies’
assessment
reports
Major Breakthroughs (III)
CTN Scheme
 Multi-national clinical trials approved by
advanced country
 One of Taiwan’s medical centers
participated
 Refer to Australian CTN scheme to
accelerate the protocol review process
 Implement since Aug 18, 2010
★CTN: Clinical Trial Notification
18
Major Breakthroughs (IV)
Biopark Cooperation
To plan the TFDA campus
and establish the Biotech
Industry Consultation and
Education Resource Center
in Nangang National
Biotechnology Research
Park
19
Future Prospect
 To create friendly
regulatory
environment
 To promote excellent
R&D infrastructure for
innovative medical
products
20
Quality
Efficiency
International
Transparency
Harmonization
20
Taiwan:
Centrally Located in East Asia
Beijing 3’00
Seoul 2’20
Tokyo 2’50
Shanghai 1’20
Osaka 2’15
Chongqing 3’00
Guangzhou 1’30
Hong Kong 1’40
Bangkok 3’45
Taiwan
Manila 2’00
Ho Chi Minh City 3’20
Kuala Lumpur 4’35
Singapore 4’20
Jakarta 5’00
21
Sydney 8’50
Thank You for Your Attention
22
22