← Dated values

Dated values

HSA post-marketing vigilance guidance Version 6

HSA post-marketing vigilance guidance Version 6

Status: final

Record details

Value
HSA uploaded Version 6 of the post-marketing vigilance guidance on 1 April 2026, revising scope, contact requirements, serious-adverse-event criteria, identifiable-patient examples, literature reports, lack-of-efficacy reports, clinical safety study reports and eCTD submission references
Unit
guidance revision
Value type
observation
Population
Companies responsible for post-marketing surveillance of therapeutic products and CTGTP in Singapore
Denominator
Guidance scope; not a marketing-authorisation decision and not a declaration that every adverse event is reportable
Reference period
Version 6 uploaded 1 April 2026
Retrieved
2026-09-02
Published
2026-04-01
Geography
sg.geo.country.singapore

Dates describe this record’s own period and applicability. A verification date does not mean a rule is currently in force.

Sources

Collection as of 2026-10-07 · An expanding collection. Published counts show available knowledge, not complete coverage of Singapore.