• Singapore HAS (Health Sciences Authority) plans to commence the development phase in 2019 in order to allow eCTD submissions by the end of 2020.
• eCTD will start with new original marketing applications (NDAs and GDAs).
• eCTD submissions will be voluntary during the initial implementation period. The requirement for mandatory submissions will be reviewed at a later date.
• The requirements for baseline submissions (quality dossiers) for currently registered products will be reviewed at a later date.