Provide an Update on eCTD 4.0 concepts, global implementation initiatives, forward compatibility from 3.2.2 towards 4.0 and what health authorities and Industry should consider before switching to eCTD 4.0./
Method
Merck participated in the eCTD 4.0 EMA Step 2 pilot (technical pilot) from July to December 2025. We did provide a total of 9 sequence covering 4 different scenarios and use cases and the learnings and outcomes are positive and highly relevant for others who did not get the chance to participate.
Results
There was a tremendous amount of exchange between us, our eCTD 4.0 software vendor and the EMA. Tens of functionalities have been tested, feedback exchanged with ENMA and vendor and we successfully came all together to a 100% valid initial regulatory submission and lifecycle.
Conclusion
The implementation of eCTD 4.0 is closer than ever. This pilot allowed the EMA to set an enthusiastic roadmap leading to mandating eCTD 4.0 as of end of 2027 with voluntary phases in 2026, which will be pioneering and impacting the implementation of eCTD 4.0 by other agencies such as the FDA, TGA, Health Canada, and SwissMedic.
