Description: The harmonized eCTD standard takes a giant step and will be upgraded to the next major version eCTD 4.0. The ICH published their latest version of the implementation guide in July 2021. Regulatory Authorities like US FDA, EMA, Health Canada and MHLW/PMDA Japan followed the road and published their regional implementation guides and finished as the next step the technical pilot phase. ANVISA Brazil plans to implement eCTD 4.0 directly - without a phase of eCTD 3.2.2. Since January 2021, the current regional timelines for eCTD 4.0 can be found on the ICH webpage. Currently, the regulatory authorities of Brazil, USA, Canada, European Union, Japan, Switzerland, and Australia plan to implement eCTD 4.0 on the basis of a voluntary use – for not later than 2023. It seems authorities are readily preparing and implementing eCTD 4.0 - but what about the industry? Is the pharmaceutical industry also aware of this change and preparing for it? Regulatory operation teams do not need to be afraid; the changes will not be as tremendous as one could expect. This presentation will give an introduction of eCTD 4.0, what is going to change with respect to eCTD 3.2.2? What can be expected by the marketing authorisation holders, regulatory affairs teams or regulatory operation teams? The presentation is going to inform the audience what will most probably change on their daily work with eCTD. The regional differences that are still part of eCTD 4.0 will be shown on a current base.
Learning Objectives:
Inform about changes in regulatory daily business due to eCTD 4.0.
Make audience aware of the timelines for eCTD 4.0.
Understand how simple the change from eCTD 3.2 to eCTD 4.0 will be.