Ectd/Ctd/Actd
eCTD/CTD/ACTD Implementation in Southeast Asia
Harv Martens ICH M2 JPMA Extedo, Inc.
The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or Association trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners.
Drug Information Association
www.diahome.org
2
xCTD Implementation
• ACTD in ASEAN countries • Singapore
– Supports both CTD and ACTD (ASEAN CTD)
• Korea accepts CTD as of March 2009 • Taiwan and others (ASEAN) accept ACTD (Taiwan will accept eCTD soon)
– Varying degrees of electronic/paper accepted
• Japan - eCTD
– One of the 3 ICH Regions – Fully supports the ICH M2 Standard
• But lifecycle is different… • And module 1 is quite different than other regions
3
ASEAN = Association of Southeast Asian Nations
10 Member Countries Member Countries Indonesia, Malaysia, Philippines, Singapore and pp , g p Thailand (1967) Brunei Darussalam (1984) Vietnam (1995) Lao PDR and Myanmar y (1997) Cambodia (1999)
ASEAN Economy
• As of 2006, ASEAN region has a 2006 population of about 560 million • Total area of 4.5 million square kilometers • Combined gross domestic product almost US$ 1,100 billion 1 100 • Total trade of about US$ 1,400 billion
Abida Syed M Haq - Ministry of Health, Malaysia
ACCSQ
• ASEAN Consultative Committee for Standards and
Harv Martens ICH M2 JPMA Extedo, Inc.
The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or Association trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners.
Drug Information Association
www.diahome.org
2
xCTD Implementation
• ACTD in ASEAN countries • Singapore
– Supports both CTD and ACTD (ASEAN CTD)
• Korea accepts CTD as of March 2009 • Taiwan and others (ASEAN) accept ACTD (Taiwan will accept eCTD soon)
– Varying degrees of electronic/paper accepted
• Japan - eCTD
– One of the 3 ICH Regions – Fully supports the ICH M2 Standard
• But lifecycle is different… • And module 1 is quite different than other regions
3
ASEAN = Association of Southeast Asian Nations
10 Member Countries Member Countries Indonesia, Malaysia, Philippines, Singapore and pp , g p Thailand (1967) Brunei Darussalam (1984) Vietnam (1995) Lao PDR and Myanmar y (1997) Cambodia (1999)
ASEAN Economy
• As of 2006, ASEAN region has a 2006 population of about 560 million • Total area of 4.5 million square kilometers • Combined gross domestic product almost US$ 1,100 billion 1 100 • Total trade of about US$ 1,400 billion
Abida Syed M Haq - Ministry of Health, Malaysia
ACCSQ
• ASEAN Consultative Committee for Standards and