eCTD Alerts: EMA Draft Implementation Package & Singapore's Implementation Updates
We created this LinkedIn newsletter to share interesting news, insights and updates from the regulatory world, and we are already reaching the 6000 people & 33 editions mark! Thank you very much for all your feedback, support and suggestions.
As we continue to grow, we want this newsletter to grow as well. Therefore, we are always on the lookout for insights and updates to include. If you would like to contribute an article, or know someone who can, feel free to reach out to me or my colleague Paul Ireland.
Now, let's get started. This edition is dedicated to some eCTD updates from October 2024.
EMA eCTD 4.0 Draft Implementation Package
The EMA have updated the draft implementation package for eCTD 4.0 on 4 October. This update includes changes to the implementation guide, additional controlled vocabularies and accepted file formats. Further updates are expected in the coming months.
Future of eCTD: eCTD 4.0 Activities
Brief Description of Change
The EMA have released an updated implementation package for eCTD 4.0, aimed primarily at eCTD tool vendors. The package includes updates to controlled vocabularies and new OIDs, as well as changes to the EMA eCTD v4.0 Implementation Guide (v1.2). The Implementation Guide update includes updates to the submission unit, submission reference, contact information and further guidance on Grouped Submissions.
While the EMA still state that they expect to begin a technical pilot for CAPs in Q4 2024, they are yet to release specific dates. We will continue to closely monitor for further information about the planned pilots and bring you further updates.
Singapore eCTD v1.0
The Singapore Health Sciences Authority published the final v1.0 eCTD specifications for the implementation of eCTD in Singapore on 25 Sep 2024.
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Health Authority Timelines
Description of Change
In the new version release, HSA has published the Implementation Package that includes SG-HSA eCTD Specification and Validation criteria, technical files (defined lists, validation matrices, stylesheets, schema), Sample eCTD submission.?
HSA will be arranging online training sessions for industry on the submission of eCTD packages via the eCTD portal in February 2025. Details will be provided at a later date via HSA | ECTD submissions.?
The target launch date of eCTD portal is March 2025. The system will be open for test submissions during the first 6 months from March to September 2025.? Test submissions will not be reviewed by the agency and will be deleted at the end of the testing period.
You can download the specification package and related documents here: HSA | ECTD submissions
About the authors
Alice Merrill is a Regulatory Information Management Consultant at Ennov . She has previously worked in Regulatory Operations at major pharmaceutical companies, with a focus on RIM.
P.S. Do you have an article or interesting insights you would like to share? That is the whole goal of our "Accelerating eCTD Submissions" newsletter. Feel free to reach out; I'm sure we can find a place for your topic as well.