adr reporting system progress and e-submissions in taiwan

19
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

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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

2

Outline

• ADR Reporting System in Taiwan

• E-submission in Taiwan

2

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

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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.

Set up ADR Reporting system (ver 3.0) for ICH E2B (R3)

in 2019

13

In the Future….

Outline

• ADR Reporting System in Taiwan

• E-submission in Taiwan

14

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

Thank you for your attention