Singapore HSA announces that electronic Common Technical Document (eCTD) format will be officially accepted for Therapeutic Products regulatory dossier submission with effect from 1 April 2026. Companies may continue with the current non-eCTD submission modes but are strongly encouraged to transition to eCTD.
- Companies may submit eCTD packages for actual dossiers through the eCTD portal using SG-HSA eCTD version 1.1, which serves as the official standard for all eCTD submissions.
- The technical files for defined lists, document matrix and submission type matrix are available online (HSA’s weblink: https://www.hsa.gov.sg/therapeutic-products/register/ectd-submissions) for real-time access and validation, along with an updated sg-regional stylesheet.
- To support users in navigating the new system effectively, HSA has also prepared the necessary resources, including the training presentation, Q&A document and a portal user manual.
In addition, HSA has updated the Guidance on Therapeutic Product Registration in Singapore (and the related Appendices) to include eCTD as a dossier submission option. The updated guidance can be found at the following link: https://www.hsa.gov.sg/therapeutic-products/guidance-documents