Many global health authorities have already adopted eCTD drug submissions. Singapore too plans to implement this system in the fourth quarter of 2024. To ease the use of eCTD in Singapore, the HSA will broadcast an eCTD regulatory guidance over the next few months. Further eCTD guidelines will be published as we get closer to the fourth quarter of 2024. Initially, the use of eCTD will be optimal but phased in over time. The HSA has said that they will base their regulations on ICH eCTD version 3.2.2. It is expected that the use of eCTD submissions will initially focus on generics and new drugs with existing DMFs.
Sending in and reviewing large amounts of information is a slow and painstaking process. eCTD submissions utilizing appropriate software generally save time, minimize errors, reduce costs, and allow for quicker submissions, leading to quicker approvals and future sales.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.