adr reporting system progress and e-submissions in taiwan
TRANSCRIPT
1
ADR Reporting System Progress and E-submissions in Taiwan
Po-Wen Yang, Division of Medicinal products,
Taiwan Food and Drug Administration
Oct. 11, 2018
History of ADR Reporting System in Taiwan
Several events related to the adverse reactions caused by terbinafine and itraconazole broke out in 1997 in Taiwan.
3
National ADR Reporting system was established in 1998. National ADR Reporting Center was established in 2003.
• Article 92: Violators of any of the provisions shall be imposed on a fine between NT$30,000 ~ NT$2,000,000.
Legislation for Pharmacovigilance in Taiwan
Pharmaceutical Affairs Act
Article 45 PSUR/PBRER
(2004.4)
Article 45-1 sADR report
(2004.4)
Regulations for Drug Safety Monitoring
(2004.9)
Procedure for Reporting Severe Adverse Reactions to Medicines
(2004.8)
Guidance for Good Pharmacovigilance Practice (GPvP) (2008)
4
Evaluation/Assessment of
Risk-Benefit Balance
Recommendation of
Risk Management Measures
Drug Safety
Advisory Committee
(under TFDA)
Regulations
Risk Management
Risk Communication
Risk Monitoring and
Signal Detection
Signal Validation and
Refinement
National ADR
Reporting Center
TFDA
Cooperation for Pharmacovigilacne
5
Pharmacovigilance in Taiwan
Pharmacovigilance
Passive
National ADR reporting system
PSUR by Drug Companies
Global Drug Safety Information Monitoring
Retrospectively Review Safety Issues from NHI Database Active
Drug Relief
Risk Management Risk communication Labeling change Withdrawal
6
Refinement and Evaluation
Serious
Death & Life-
threatening
Initial report within 7 calendar days
and comprehensive report within an
additional 8 calendar days
Others Within 15 days
ADR reporting obligation of MAH
Serious case
• Death
• Life-threatening
• Permanent disability/incapacity
• Congenital anomaly/birth defect
• Results in hospitalization or prolongation of an
existing hospitalization
• Needs further management for other possible
permanent injuries
7
ADR Reporting System
8
ADR cases Source: Healthcare providers, Pharmacies, Pharmaceutical companies ,the general public
Domestic cases Coding (drug and event):
• ATC • MedDRA
Causality assessment (WHO causality) for serious cases
Signal detection • Case review • Data mining
Taiwan ADR reporting center
Online Fax, E-mail
~15000 domestic cases in 2017 • ~80% from Healthcare providers • ~20% from Pharmaceutical
companies
ADR Reporting system (ver 2.0) in Taiwan
hospitals pharmacies patients CRO manufacturers
Reporting portal
Drug SAE / SUSAR
Pool data
Data Analysis, Signal detection
Vaccine
Data classification
Launched in April 2013
9
Features of ADR Reporting system (ver 2.0)
• Single entry for MAHs, HCPs and the penitents
• Personalized Interface
– Search and follow up historical reports
• Computer-aid data collection & standardization
– Checking the categories of the e-sub filled-out
– Assigning corresponding databases; for example library of domestic medical products license registry, company/hospital registry information, etc.
• Coding Dictionary
– ATC, MedDRA
– Auto coding
• Case management
10
0
2000
4000
6000
8000
10000
12000
14000
16000
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
316
1524 1831 2325 2552 2507
3722 4629
6971
8316
10320 10555 10402 11357
10667 11399
12815
14102
15422
Trends of ADR Reporting in Taiwan
Included in Pharmaceutical Affairs Act (2004)
Included in Hospital Accreditation items
(2006)
year
Set up ADR Reporting system
(ver 2.0) (2013)
11
number of reporting
The analysis of ADR reporting source N
um
be
rs
0
2000
4000
6000
8000
10000
12000
2011 2012 2013 2014 2015 2016 2017HCP 9080 9779 9405 9468 10676 11396 11982
MAH 937 1222 1155 1900 2119 2696 3422
Patients 8 1 11 9 10 4 11
The numbers of ADR reporting from HCPs and industries are also increasing base on setting up ADR Reporting system.
ExPRESS
(E platform for Review & Submission)
-To improve the medicinal product review and submission efficiency. -To be in line with the international trends. -To save energy and reduce carbon emission.
15
Applicant Paper-based
Reviewer Paper-based
2
3
1 Time and Energy consuming
Documents delivery and archiving issues
Data searching and examine problem
Past- Paper-based work stream
16
ExPRESS
Filing Received
Administrative documents Technical documents -E-submission
Preliminary check
Disc Documents upload
Review &Examine
Review Report
Administrative Assistant
Reviewer
Receiver
e-CTD Builder
Applicant
Website for review Website for applicants
FTP server Database server
Technical documents -Disc
17
Application Database
Refine review process
Efficiently search& examine
Paperless work stream
Post-Approval Change
Fully implement
INDs、 NDA、ANDA…
Extension (pilot project since 2018)
ExPRESS
(E platform for Review & Submission)
18