Singapore

HSA has not announced adoption of eCTD v4.0. Singapore's current eCTD framework is built on the ICH eCTD specification 3.2.2, accepted on a voluntary basis from 1 April 2026. Watch HSA's eCTD page for any future v4.0 roadmap; HSA states it will give advance notice before later implementation phases.

Do not expect a v4.0 switch plan for Singapore yet. The current baseline to master is ICH eCTD 3.2.2 with the Singapore regional Module 1 (SG-HSA Specification v1.1). Build submissions against that, not v4.0.

HSA officially accepts eCTD for therapeutic-product regulatory dossiers from 1 April 2026. The framework is based on the ICH eCTD specification 3.2.2; the regional Module 1 is governed by the SG-HSA eCTD Specification v1.1, which is the official standard for all eCTD submissions to HSA. Submissions are made through the HSA eCTD Portal (ectd.hsa.gov.sg). Acceptance is voluntary (initially covering new drug applications, generic drug applications and their corresponding DMFs); non-eCTD submission modes remain permitted, and HSA will give advance notice before later phases.

Use the SG-HSA eCTD Specification package v1.1 (the current official standard) for all submissions: it includes the SG-HSA eCTD Specifications v1.1, Validation Criteria v1.1, defined lists, submission- and document-type matrices, and the regional SG-HSA Module 1 schema. Modules 2–5 follow the ICH eCTD 3.2.2 specification. Validate against the v1.1 criteria and self-check before sending through the HSA eCTD Portal. The earlier v1.0 package remains available. HSA also publishes a Q&A document and a Summary of Envelope Requirements.