INDUSTRY CONSULTATION ON ELECTRONIC COMMON TECHNICAL DOCUMENT (eCTD) IMPLEMENTATION IN SINGAPORE
HSA is planning to introduce eCTD to enable full e-submissions thereby minimising the need for submitting documents using storage media such as CD/DVD ROMs.
HSA is working with our appointed vendor to develop the eCTD system (ICH eCTD version 3.2.2) in Singapore. The initial launch will be open to new drug applications, generic drug applications and their corresponding Drug Master File (DMF) submissions. HSA will adopt a phased approach and the use of eCTD for dossier submissions will be on a voluntary basis.
The purpose of the consultation is to provide an opportunity for industry to comment and submit feedback on the eCTD regulatory package for Singapore which will be published on 2 May 2023. This package includes the Singapore Regional Specification document, Module 1 Envelope Attributes and Defined Lists, Heading Elements and eCTD Validation Criteria.