Did you know that Thailand is the first in ASEAN to implement eCTD as early as 2016?

In Asia, eCTD is fully implemented in Australia, while China and Singapore are implementing the eCTD submission infrastructure in 2023. South Korea and Taiwan are also experimenting eCTD with submission on a voluntary basis.

eCTD offers benefits in structured submission and infrastructure to enable efficient products life-cycle management. Implementing eCTD with local specific requirements, however, will hamper the full potentials of benefits that eCTD intended to offer.

Are you preparing to meet the eCTD requirement in Asia’s filings? Then this is the workshop that you can't miss.

Highlights of the Workshop:

• eCTD fundamentals and benefits
• Is my product eligible for eCTD?
• What is the difference in submission structure between the 2 versions?
• What are the benefits of eCTD v4.0 compared to the older eCTD 3.x standard
• What are implementation differences across regions?
• How long does it take for me to know that my filing has been accepted for eCTD?
• What are the important technical details?
• Will I get notified during the various stages of review?
• eCTD Implementation should be on a phased approach – the way the Australia TGA approached it. How can we leverage lessons learned from the TGA’s experience?
• Consequences of country specific requirements – what are they and how to minimize?
• Can I provide comments or recommendations on the eCTD processes?

PROGRAM AGENDA

14:00 - 14:20 Understanding eCTD and its utility

• Overview, Use and benefits of eCTD to NRA and industry (validation criteria, portal (meta-data), dataX, LCM utility: technology)
• Status of implementation across regions

Isabelle Tan, Regional Regulatory Affairs Senior Specialist MSD

14:20 - 14:40 Experience of TGA in using a phase approach for implementing eCTD
TGA Speaker

14:40 - 15:00 Experience of EMA (using gateway – allows 2-way communication)
Kristina Puusaari, EMA

15:00 - 15:30 Q&As

Moderators:

James Leong, Head, Health Products & Regulatory Science Centre of Regulatory Excellence (CoRE), Duke NUS Medical School, Singapore
Sannie SF Chong, Senior Director, Global Regulatory Policy, MSD International, Singapore
All above speakers

15:30 - 16:00 Coffee Break

16:00 - 16:30 Progress update of eCTD implementation in Asia (extrapolate ideal model to Asia)

• Key progress
• Concerns on process and technology
• Challenges

Jiao-Ying Chuang, Reviewer - Division of Medicinal Products, Taiwan FDA (TFDA)                              Boon Kian Lim, Regulatory Consultant - Therapeutics Products Branch, Health Science Authority (HSA)
Rakesh Neelam, Regional Regulatory Affairs Manager, MSD

16:30 - 17:30 Discussion (competency gap, training needs)

• Good practices for implementation eCTD



- Addressing operational concerns for seamless implementation of eCTD to support local registration   processes

- Proposals for overcoming country specific requirements when using eCTD – seamless use across   ICH countries to rest of world

- Harmonisation efforts across ASEAN and Asia Pacific

• Competency gaps and barrier

All above speakers

17:30 End