Singapore Making ‘Key Changes’ Ahead Of eCTD Implementation

Submission order, identifiers and electronic signatures in pdfs are among the issues that the Health Sciences Authority is addressing as it prepares to implement the electronic common technical document format for dossier submissions this year.

Dossier submission via eCTD allows for better product life cycle management • Source: Shutterstock

Singapore’s Health Sciences Authority has provided an update on its planned implementation of the electronic common technical document (eCTD) format for dossier submissions and the key changes it is making following a consultation on the plan that received over 250 comments from 25 companies.

Companies using the eCTD format, which the HSA expects to introduce in Q4 2024, will no longer be prohibited from...

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